Leading a life sciences company comes with a unique level of responsibility. The decisions taken in boardrooms do not stop at business performance. They influence patient outcomes, regulatory trust, investor confidence, and in some cases, public health itself.

That responsibility also comes with a level of scrutiny that is materially different from most sectors.

Over the last several years, the regulatory landscape for life sciences companies has become more layered, more global, and far more unforgiving of oversight gaps. Expectations around governance, clinical integrity, disclosures, product safety, adverse event reporting, and data stewardship have evolved significantly. What may have been considered adequate governance a few years ago may no longer withstand scrutiny today.

For directors and officers, this is no longer only a corporate risk. Increasingly, it is a personal one.

When corporate issues become personal liability

Many directors understand, at least broadly, that they carry fiduciary responsibilities. What is often underestimated, however, is how quickly a regulatory issue can translate into personal legal and financial exposure.

An inquiry arising from a product issue, an allegation around inadequate disclosures, concerns over clinical or operational governance, or even a regulatory investigation into compliance failures can extend beyond the company itself. Directors and officers may find themselves personally named, drawn into lengthy investigations, defence proceedings, or reputational challenges — even where there has been no deliberate wrongdoing.

In life sciences, accountability is increasingly attached to named individuals, not merely institutions.

This is precisely where Directors & Officers (D&O) insurance is expected to respond. Yet, in my experience, one of the most common assumptions boards make is equating the existence of a D&O policy with adequate protection.

The more important question is this: Was the policy designed for the regulatory anatomy of your business?

Why generic D&O structures often fall short

Life sciences is not a conventional corporate environment. The sector operates under an intricate framework of approvals, compliance obligations, inspections, pharmacovigilance requirements, clinical governance, quality controls, and increasingly, cross-border regulatory expectations.

As companies scale — whether through international expansion, partnerships, fundraising, acquisitions, or product diversification — their liability profile evolves rapidly.

Yet, many D&O programmes continue to be structured as standard corporate placements.

This is where vulnerabilities often emerge.

For example, boards should evaluate whether their D&O framework adequately addresses:

• Regulatory investigation costs, particularly where individual directors may require legal representation early in proceedings
• Cross-border exposure, especially for organisations operating or raising capital across multiple jurisdictions
• Governance failures linked to clinical, product, or compliance oversight
• Data and disclosure-related liabilities, as healthcare and life sciences businesses become increasingly digitised and data-dependent

These are not theoretical risks. They are practical governance realities in a sector where regulatory expectations continue to rise.

D&O should evolve as the business evolves

One of the most overlooked aspects of D&O insurance is that it is often treated as an annual procurement exercise rather than a strategic governance tool.

A company that was primarily domestic two years ago but now exports, operates across regulated markets, or has institutional investors on its cap table is fundamentally different from a liability perspective.

Similarly, events such as:

• onboarding independent directors,
• entering regulated international markets,
• expanding into new therapeutic or healthcare categories, or
• preparing for fundraising or strategic transactions

should act as natural triggers to reassess whether the existing D&O structure still reflects the organisation’s actual exposure.

The policy that worked for yesterday’s business may not be sufficient for today’s board.

D&O as a governance signal

Increasingly, sophisticated investors, lenders, and independent directors view D&O insurance as more than a risk-transfer mechanism. Quietly, it has become an indicator of governance maturity.

Strong boards recognise that protection is not merely about insurance limits. It is about whether the wording, scope, and response mechanisms are aligned to the realities of the business they govern.

In a sector as regulated and consequential as life sciences, being underprepared is itself a risk.

The organisations that navigate this well are typically the ones that approach risk management not as a compliance obligation, but as an extension of responsible leadership. In life sciences, where trust is central to long-term success, that distinction matters.

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CMT2S is a rare, inherited neurological condition that progressively causes muscle weakness and motor function loss.

VCA-894A is being investigated specifically for a patient who was diagnosed early in life with this rare subtype of Charcot-Marie-Tooth disease.

The therapy’s target is a specific genetic variant of CMT2S, which to date has not been observed in other patients.

As determined by the FDA, CMT2S predominantly impacts individuals from birth up to 18 years of age, meeting the established criteria for a rare paediatric disease.

The agency noted in its designation letter that severe disease symptoms largely affect paediatric patients.

Vanda Pharmaceuticals president, CEO and chairman Mihael Polymeropoulos said: “CMT2S is a devastating inherited neuropathy for which patients and families have limited treatment options.

“The FDA’s rare paediatric disease designation recognises the significant unmet medical need in this patient population and supports our efforts to develop a potentially transformative therapy for patients affected by this rare disease.”

The designation is designed to encourage development of new therapies for serious rare diseases mainly affecting children.

Through this, sponsors may qualify for a priority review voucher if their product achieves approval for a marketing application, although the FDA will determine final eligibility at the time of application review.

Vanda Pharmaceuticals is continuing to progress the development of VCA-894A and is coordinating with the FDA on its clinical programme.

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Whitehawk Therapeutics will assess them in conjunction with its own ADC linker-payload platform.

Following the evaluation, Whitehawk can choose to further advance any resulting BsADC candidates as part of its pipeline.

Biocytogen’s RenLite platform uses a common light-chain design to support the discovery and optimisation of fully human bispecific antibodies across a wide range of target combinations.

This approach is intended to minimise the risk of light-chain mispairing during development and to support subsequent work on BsADCs.

The collaboration is structured to leverage Biocytogen’s antibody generation capabilities and Whitehawk’s expertise in ADC technologies, with the aim of identifying BsADCs that have differentiated targeting characteristics.

Biocytogen president and CEO Dr Yuelei Shen said: “Whitehawk has established strong expertise in ADC technology and oncology drug development. This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development.

“We look forward to supporting the efficient advancement of multiple programmes by contributing high-quality antibody molecules and integrated research capabilities to identify differentiated therapeutic candidates and ultimately bringing new treatment options to patients with cancer.”

Financial terms include an upfront payment to Biocytogen, with eligibility for additional payments tied to development, regulatory and commercial milestones, as well as low single-digit royalties on net sales.

Other financial details have not been disclosed. If Whitehawk opts to move forward with any BsADC candidates developed through the partnership, it will hold global rights and complete programme control over them.

In April 2026, Biocytogen entered a strategic partnership with Sihuan Pharmaceutical to advance new therapeutics across several disease areas, including weight loss.

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The recent H5N1 avian influenza resurgence in poultry farms in certain districts of Maharashtra and Karnataka once again reminds us that human health is connected to animal health. How has animal health science and research evolved to meet these challenges? 

When we see outbreaks like H5N1, it is a very real reminder that animal health and human health are deeply connected. These are not abstract public health concepts. They affect farms, families, food systems, trade and livelihoods, often very quickly. 

Highly Pathogenic Avian Influenza (HPAI) remains one of the most serious threats to global animal health. India has had experience with H5N1 since its first poultry outbreak in Maharashtra in 2006, so the current resurgence builds on a history that has already shown why vigilance, rapid response and coordination matter. According to the World Organisation for Animal Health’s HPAI Situation Report 71 dated May 2025 (1), HPAI has led to the death or mass culling of more than 633 million poultry worldwide between 2005 and 2024, and the recent spread of H5N1 beyond poultry into other species, including mammals, reinforces why surveillance and scientific readiness matter.prediction, prevention, detection and rapid response – from biosecurity and genomic sequencing to faster diagnostics, better field-level.

What has changed is the speed and precision of animal health science. The response is no longer only reactive. It is increasingly built around surveillance and data sharing. 

At Zoetis, this aligns closely with how we think about innovation. With nearly 75 years of experience in animal health, our role is to support veterinarians, producers and public health systems with science that helps predict, prevent, detect and treat disease. 

But science only delivers when the systems around it are strong. That means robust biosecurity, surveillance, rapid diagnostics, transparent reporting and collaboration across government, industry and the veterinary community. Where appropriate and permitted by local policy, vaccination can also be part of that broader disease-control strategy. That is One Health in practice. 

What can be done to proactively detect and predict zoonotic spillover incidents, especially as industrial livestock farming intensifies? 

The shift we need is from waiting for disease to appear, to building systems that help us prevent disease and detect risk earlier. That means stronger biosecurity, surveillance, better field-level sampling, faster diagnostics, genomic sequencing, and the ability to connect data across animal health, human health and the environment. Biosecurity remains fundamental, but it cannot stand alone. It needs to be supported by surveillance, diagnostics, responsible vaccination strategies where appropriate, and clear channels for rapid reporting and response. 

The real opportunity is to make those systems more connected. If something is detected at farm level, that information should move quickly through veterinary, public health and government systems so that risk can be assessed and action taken earlier. Digital platforms, data analytics and AI can support this by helping identify patterns, prioritise risks and enable faster decisions. 

At Zoetis, we have a long history with avian influenza beginning in the early 2000s when we developed a vaccine in response to outbreaks in SE Asia. Since then, we continue to monitor avian influenza as well as many other zoonotic diseases so we can be ready with updated solutions if warranted. 

We are also investing in genomics, predictive analytics and digital tools, and our India Capability Centre is part of that global capability. As livestock systems become more complex, the most effective approach will be a connected One Health system: good farm practices, strong veterinary capacity, science-led surveillance and prevention and close collaboration across industry, government and public health authorities. 

How is India’s poultry sector evolving vis a vis other countries? Has it demonstrated the capability to tackle such public health challenges while balancing growth imperatives? 

India’s poultry sector is evolving quickly, and its importance goes well beyond agriculture. Poultry is one of the most accessible sources of animal protein, and India is now the world’s second-largest egg producer. India also ranks fourth globally in overall meat production, with poultry accounting for nearly half of the country’s meat output. 

The opportunity is significant, but so is the responsibility. As the sector grows, strong animal health systems become even more important. Among larger integrated producers, we are seeing greater focus on biosecurity, veterinary oversight, housing, hygiene and disease prevention. That is encouraging because animal health is not only a welfare issue. It is a productivity, food security and public health issue. India has demonstrated the ability to respond to animal disease threats through national and state-level surveillance, reporting and containment systems. At the same time, recent avian influenza outbreaks show that the next step is consistency: ensuring good biosecurity, veterinary access, rapid reporting and preventive health practices across the full poultry ecosystem. 

What is encouraging is India’s pace of modernisation, technical talent and growing recognition that prevention is far less costly than a serious outbreak. The poultry markets that will lead over the next decade will not simply be those that produce more, but those that grow responsibly and build resilience into the system. 

What are the latest technologies available in this space? 

There is a great deal of innovation happening across poultry health, and I would group it into three areas: prevention, production systems and decision-making. 

On prevention, vaccine science is becoming more precise and adaptable as disease threats evolve. Vector and recombinant vaccines are a fast-growing area, and approaches such as DIVA – Differentiating Infected from Vaccinated Animals – are increasingly important because they support surveillance, disease control and confidence in global trade.

The way vaccines are delivered is also changing. India has seen a remarkable shift from more conventional farmlevel vaccination and treatment-led protocols toward hatchery vaccination and prevention-led health programmes. For Zoetis, our in-ovo vaccination technologies, including Inovoject and Inovoject NXT, are strong examples. They support vaccine delivery during incubation, helping hatcheries automate and standardise vaccination at scale. India has adopted this technology quickly and is one of Zoetis’ strongest markets in Asia for in-ovo vaccination, reflecting how fast the sector is modernising. 

Beyond vaccines, environment-controlled farming is another important advancement. Better control of temperature, ventilation, humidity and housing conditions can improve predictability, productivity and flock health. 

On detection and decisionmaking, faster diagnostics, field-level sampling, genomic sequencing, environmental surveillance, digital platforms and AI are all changing what is possible. They can help identify risks, support faster decisions and strengthen the connection between farm-level signals and public health response. 

That is the direction poultry health innovation is moving in: stronger prevention, more consistent production systems, faster detection and more connected decision-making. 

How affordable and implementable are these technologies for India’s poultry sector, given that each country would have localised situations linked to capex, labour available at poultry farms etc? 

These are exactly the right questions, because technology only matters if it can be implemented in the system where it is needed. In a market like India, affordability and practicality are just as important as scientific sophistication. 

The answer will not be the same for every part of the poultry sector. For larger integrated producers, many technologies – from improved vaccination systems and stronger biosecurity to digital monitoring and diagnostics – are increasingly viable because the business case for prevention is clear. 

For smaller and mediumscale producers, the model has to be different. It cannot depend on every farmer making large capital investments. Shared infrastructure, veterinary extension services, practical farm-level training and partnership models become much more important. For smaller and mediumscale producers, the model has to be different. It cannot depend on every farmer making large capital investments. Shared infrastructure, veterinary extension services, practical farm-level training and partnership models become much more important. 

This is where Zoetis can bring value beyond products alone. We bring both products and services – including technical knowledge, training, field support and experience from different markets – which can help producers of different sizes adopt solutions in a way that is practical for their operations.India also has an implementation advantage: people on the ground. Farm workers can observe changes in flock health, follow biosecurity protocols and escalate concerns quickly, but only if they are trained, supported and given clear protocols. 

So the technologies are implementable, but not through a one-size-fits-all model. The right approach is tiered: advanced systems for larger integrated producers, shared access and support models for smaller producers, and strong basic biosecurity, surveillance and training across the sector. That is how we can partner in the industry’s transition to become more efficient, resilient and sustainable. 

A key feature of preventive strategies is vaccination, be it human or animal health. What are the latest offerings in this space for animal health and the advantages over traditional methods? 

Vaccines are one of the most important tools we have in preventive animal health. Across livestock, poultry and companion animals, they help protect animal welfare, support more reliable food production, and reduce the need to use antimicrobials to manage disease. That is why vaccines should be seen as part of core health infrastructure, not just as a response during an outbreak. 

What is changing is the precision of vaccine science and the consistency of delivery. Compared with more traditional approaches, newer vaccine technologies can be more targeted, more adaptable to changing disease threats, and easier to deliver consistently at scale. In areas such as avian influenza, they can also support surveillance through strategies like DIVA, which we discussed earlier.

Delivery is advancing too. Zoetis in-ovo vaccination technologies, including Inovoject and Inovoject NXT, help hatcheries automate and standardise vaccine delivery at scale, which is especially relevant for modern poultry systems.For India, the opportunity is to make prevention practical across different production systems. That means combining strong vaccine science with biosecurity, surveillance, training and technical support, so that innovation works not only in theory, but in the day-today reality of farms, hatcheries and veterinary practice. 

What is Zoetis’ annual spend on R&D as a percentage of overall revenues? Give us an idea of the projects in the animal health research pipeline to watch out for in this space. 

R&D is central to who we are as a company. Since our IPO, Zoetis has invested more than $6 billion in research and development, reflecting our sustained commitment to science-led innovation. 

What matters is not only the level of investment, but where it is focused. Our pipeline includes 12 potential blockbuster candidates across areas of significant unmet need, including chronic kidney disease, oncology, cardiology, anxiety and obesity in companion animals. We are also continuing to advance innovation in core areas such as osteoarthritis pain, dermatology, vaccines and livestock health. 

One area to watch is precision animal health. Zoetis has announced an agreement to acquire Neogen’s animal genomics business, which would strengthen our capabilities in genomic technologies and data-led insights for livestock producers, subject to closing and regulatory approvals. 

More broadly, the future of animal health will be increasingly integrated. It will not be medicines, vaccines, diagnostics or data in isolation, but these capabilities working together to help veterinarians and producers predict, prevent, detect and treat disease earlier and more effectively. That is where we see the next wave of innovation. 

Besides industrial livestock, the One Health philosophy includes the pet and companion animals. What is the current share of global revenues coming from India and what is predicted growth of the overall animal health market in India? 

India sits within our International segment, which remains an important growth driver for Zoetis. In our most recent quarter, our International segment delivered 10% organic operational growth, and India is an active part of that broader story. The market itself is very promising. Public estimates vary, but India is widely expected to be a high-growth animal health market, driven by the continued importance of livestock and poultry, as well as the rapid evolution of companion animal care. 

On the companion animal side, we are seeing a clear shift. Urbanisation, rising incomes, changing family structures and the growing role of pets in households are changing expectations of veterinary care. Pet owners are becoming more aware of prevention, diagnostics, parasite protection, dermatology and chronic disease management – not just treatment when something goes wrong. 

For Zoetis, the opportunity is to support that transition across both livestock and companion animals: helping producers improve health, productivity and disease prevention, while supporting veterinarians and pet owners with innovative solutions that improve quality of life for pets.

That is One Health in practice – stronger animal health, stronger veterinary capacity and better preventive care contributing to healthier animals, people and communities. 

What are Zoetis’ plans for India? Where does it fit into the company’s overall strategy, besides being a huge market? 

India is an important market for Zoetis, and not simply because of its size. What makes India distinctive is the combination of commercial opportunity, scientific capability and technology talent.We have a strong commercial presence in India, a Veterinary Medicine Research and Development presence in the Mumbai-Thane area, and our Zoetis India Capability Center in Hyderabad, which has become an important part of our global digital and technology capability. That gives India a role beyond local market growth – it contributes to how we innovate for customers globally. 

On the ground, our focus is to expand access to our portfolio across livestock and companion animals, while bringing global innovation to Indian veterinarians, producers and pet owners in a way that fits the market. That includes preventive care, productivity, diagnostics, dermatology, pain management and digital tools that support better decision-making.

More broadly, we want to be a long-term partner in strengthening India’s animal health ecosystem. As India’s ambitions in food production, productivity and companion animal care continue to grow, strong animal health infrastructure will be a critical enabler. What gives me confidence is the depth of talent we see in India – across our teams, our customers, and the veterinary and technology communities we work with. 

References: 1. High Pathogenicity Avian Influenza (Hpai) Situation Report 71 https://www.woah.org/app/uploa ds/2025/06/hpai-report-71.pdf 

viveka.r@expressindia.com
viveka.roy3@gmail.com 

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For a long time, pharma packaging was treated as a back-end function something that got done after the formulation work was complete. The focus was on cost, compliance, and timelines. That view is changing. As geopolitical tensions affect shipping routes, energy prices, and raw material supply, packaging has moved into sharper focus for procurement, supply chain, and leadership teams across the Indian pharmaceutical. 

The triggers are well known: Pritam Shimpi, General Manager-Supply Chain, ACG Packaging Materials explains, “Geopolitical risks are now directly influencing pharma packaging operations. Tensions in the Middle East, uncertainty around key trade routes, freight disruption, energy volatility, war risk and insurance premiums, currency movement, and potential trade restrictions, sanctions, or sudden regulatory changes are creating pressure across the packaging value chain. For Indian pharma packaging, the implications are significant because several packaging inputs are linked to global supply networks, crude derivatives, metals, polymers, films, additives, energy, and international logistics. Any disruption in raw material flow, port operations, shipping routes, container and vessel availability or insurance availability can affect lead times, landed costs, and production planning.” 

“Pharma packaging has therefore moved from being a cost focused support to a critical supply continuity enabler for pharma customers.” 

These are not new developments, but their combined effect on pharma packaging like a function that depends on polymers, aluminium, glass, specialty films, and stable logistics has been meaningful. 

Manish Jain, Director, Naprod Life Sciences, says the impact extends beyond logistics. “Escalating geopolitical tensions, including conflicts in the Middle East and disruptions to critical maritime chokepoints, are creating volatility in global freight, crude and petrochemical markets, directly affecting the availability and pricing of packaging raw materials, increasing transit times, and exposing supply chains to greater risk of delay or interruption. Geopolitical risk also intersects with trade policy shifts, tariffs and export restrictions that can complicate cross-border movement of packaging supplies while amplifying cost pressures and compliance burdens across global markets.” 

Jitendra Srivastava, CEO, Triton Logistics and Maritime, offers a view from the logistics side, “One of the biggest lessons from this year’s geopolitical disruptions is that the most critical risks in pharma are often invisible until they affect continuity. What appears to be a shipping issue quickly becomes a manufacturing issue. Extended transit times, rerouting through the Cape of Good Hope, and changing vessel schedules influence production planning, packaging availability, and inventory cycles.” 

What has changed on the ground 

Giving a market analysis, Ankush Kapoor, Founder, PharmNXT said, “While India’s pharma exports grew by over 5 per cent to $28.29 billion during April-February FY26, the industry’s $32 billion FY26 export target is considered challenging due to tariff uncertainties and geopolitical risks. Achieving this would require exports of nearly $3.7 billion in March 2026, compared to about $1.6 billion in March 2025. 

Dhananjay M. Chaudhari, DGM-Packaging Development(Formulations), Indoco Remedies notes, “India’s pharma exports is rising upto almost by 10 per cent year-onyear, showing the broader export momentum behind generics. More than 60 per cent of exports go to stringent regulatory markets, which strengthens India’s reputation as a reliable supplier of affordable medicines. The recent MiddleEast geopolitical crisis raises packaging material costs, tighten supply and increase logistics risk for India’s pharmaceutical packaging.” 

The industry’s ability to supply these markets reliably depends, in part, on a packaging supply chain that has historically been built around cost efficiency and singlesource procurement. That approach is now showing its limits. 

The most visible impact has been on input costs. Urvee Garg, Director, HAB Pharma, shares what the organisation has seen directly, “Prior to the conflict, PVC was being procured at approximately Rs 115 per kilo; currently, prices have increased to nearly Rs 150 per kilo, although we expect them to stabilise at around Rs 135 per kilo. Similarly, aluminium foil (Alu) prices have surged from around Rs 480 per kilo before the conflict to nearly Rs 650 per kilo now. These are just small examples highlighting the increase in tablet packaging material costs.” 

Rajendra Prasad A, AGMPackaging Development, Maiva Pharma provides a wider view of cost movement, “The Iran–US–Israel conflict and disruptions in the Hormuz have emerged as one of the most critical risks in 2026. This has impacted energy supplies (oil, gas), petrochemical feedstocks (critical for plastics and polymers) and global shipping routes. India imports a significant portion of crude oil via this region, and disruptions have caused raw material cost increases significantly in some cases and plastic resin prices from 50 per cent to 60 per cent. 

He also notes that, “Recent tariff escalations particularly from the US and EU have introduced higher input costs (metals, polymers, components), uncertainty in export markets and supply chain reconfiguration pressures. Tariffs of 20–40 per cent (potentially up to 200 per cent) on pharmaceutical-related goods are expected to increase cost burdens and force relocation strategies.” 

Since packaging materials from PVC and HDPE to aluminium and specialty films are tied to petrochemical and energy markets, any disruption in feedstock supply or energy pricing tends to move through the entire packaging value chain.

The feedstock connection 

To understand why pharma packaging is affected, it helps to look upstream. Many packaging materials are manufactured from petrochemical feedstocks such as naphtha, ethylene, and propylene. India imports a significant share of these from the Middle East region. 

Chaudhari explains, “Feedstocks such as naptha, ethylene, propylene and other derivatives which India is mainly exporting from Middle-East region is hampered due to Middle-East crisis. Many primary packaging materials such as bottles, blister films production is constrained due to reduced supply or shipping of feedstock causing tightened supply and price hike affects almost all pharmaceutical sector in India.” 

On the logistics side, route disruptions have added to the challenge. Shivaji Chakraborty, Head of Packaging Development, Fresenius Kabi Oncology notes, “Attacks in the Red Sea and tensions in the Strait of Hormuz force vessels to reroute around Africa, adding weeks to transit times and sharply increasing the freight costs forcing Indian farms to rethink sourcing strategies.” For temperature-sensitive products, longer transit times also raise questions around product integrity. Chaudhari points out, “Just-in-time inventories with only weeks’ cover are vulnerable — shortages are forcing production slowdowns, product reformulation, or use of inferior substitutes that may affect regulatory compliance or shelf-life.” Dr Sufi Roomi, Medical Spokesperson, Jolly Healthcare shares, “One of the main risks today is overdependence on limited geographies for all packaging inputs, well specialised materials, polymers and other allied suppliers. Any kind of disruption in shipping routes, customs movement, cost of energy and directly impact timelines of packaging and in turn product dispatches schedule. For all pharma companies, even a slight delay in availability of packaging can impact market commitments, and patient access.” 

Availability is as much a concern as cost 

Rising costs are one issue. The other and in some situations the more pressing one is availability. When supply is tight, materials can go to buyers who pay a premium or commit to advance payments, leaving others with longer lead times or gaps in supply. 

Jain says the current environment has exposed structural dependencies in packaging sourcing. “Packaging material availability is being stressed by supply chain dependencies on foreign petrochemical inputs and long logistics corridors, while shipping route disruptions cause lead time volatility and higher insurance and freight costs; this, combined with heavy reliance on imports of specialised materials such as polymers and barrier components, can impede operational continuity and force firms to reallocate inventory, change carriers, or resort to costly expedited shipping.” 

Garg describes a specific situation her organisation has faced, “We have one product that is an extremely important brand for us. To prevent counterfeiting, we use a holographic film on the PVC sheet for its packaging. We currently have two approved vendors for this material, both of whom are very large listed companies specialising in high-security packaging solutions. However, even these suppliers are facing difficulties in maintaining consistent supply during the current conflict situation. This, in turn, has a significant impact on our operational continuity.” 

The regulatory structure of the pharma industry means that supplier changes are not quick. An alternate source needs to go through qualification, documentation, and change control before it can be used. When even established, approved suppliers face supply issues, companies have limited immediate options. 

Shimpi frames the implication for how the industry needs to think about suppliers, “Supplier reliability is no longer measured only by price and quality; it must also include continuity capability, feedstock risk management, early communication, and compliance support.” 

Srivastava puts the same point in the context of logistics planning, “The challenge today is less about whether packaging materials are available and more about whether they arrive with the predictability that pharmaceutical operations require. Inputs that once moved through stable freight cycles are now exposed to disruptions that can alter timelines with little warning, creating uncertainty across production schedules and supplier commitments.” 

A different kind of risk: Compliance and serialisation 

tics, there is a dimension of the geopolitical impact that tends to get less attention: the effect on compliance and serialisation. As trade relations between countries shift, destination markets are introducing their own data and traceability requirements, and these are not always aligned with each other. 

Siddharth Reddy, CoFounder, AltiusHub mentions, “The risk most operators underestimate is not material scarcity but regulatory fragmentation. As trade blocs harden, every major destination market is mandating its own serialisation and reporting regime, and they are diverging rather than converging. India exports to over 50 regulated markets, each with its own data format, reporting cadence and national portal. A packaging line that was compliant for one corridor can be non-compliant for another overnight when a regulator updates a mandate. The geopolitical story for packaging is increasingly a data-sovereignty story, not just a logistics one.” 

Reddy also highlights an aspect of the hardware supply chain that many quality teams have not had to consider before, “The industry’s dependence on a narrow set of geographies for specialty films, foils, aluminium, and crucially the electronic components inside vision systems and printand-apply hardware, means a single export control or port disruption can idle a line even when the drug substance is available. We have seen lead times on serialisation-grade printers and cameras stretch precisely when shipping lanes get politicised. Packaging continuity now depends on hardware supply chains that most quality teams have never had to think about.” 

This points to a broader reality. The packaging function today has more dependencies on materials, logistics, hardware, and data infrastructure than it did even five years ago. Each of these can be affected by geopolitical developments, and they do not all respond to the same mitigation strategies. 

How companies are responding 

Across the industry, the response to these pressures has broadly moved in a few directions: building buffer stocks, qualifying more suppliers, diversifying sourcing geographies, and investing in supply chain visibility. 

Chakraborty outlines the near-term actions being taken: “Build safety stock of imported packaging materials, viz., aluminium foils, polymers, and inks to absorb shipping delays… use multimodal transport (air, sea and rail) and reroute via Europe or Central Asia to avoid Red Sea bottlenecks… Source packaging materials/raw materials from other countries including Europe to reduce dependency on China and Gulf countries.” 

Garg describes the broader pattern she has observed: “Pharma companies are increasingly adopting multi-vendor sourcing strategies and expanding partnerships with domestic packaging suppliers to reduce overdependence on single geographies or suppliers. Vendor qualification programs are also being strengthened to build flexibility and ensure continuity during disruptions. Many organisations are maintaining higher safety stocks for critical packaging materials and investing in better forecasting and supply chain visibility tools.” 

Kapoor identifies the shift in thinking this is prompting: “There is a shift away from the lowest cost supply chain philosophy to that of lowest risk qualified supply. This is evident in firms making safety stocks for critical components, qualifying alternative suppliers, regionising critical raw material supplies as well as getting packaging and process containment vendors involved early on in the manufacturing design.” 

Srivastava describes this same shift from the logistics side: “The most significant change we are witnessing is a move away from efficiencyonly models toward resilienceby-design. Pharma companies are no longer treating alternate routes as contingency plans; they are becoming part of the network architecture from the outset. Dual-route sourcing strategies, diversified ports of entry, and multimodal flexibility are increasingly standard expectations rather than exceptional measures.” 

He also highlights what visibility can do for companies during periods of disruption: “Real-time shipment intelligence allows disruptions to be identified early and responses to be activated before they escalate into operational challenges. The invisible journey of a resilient supply chain lies in its ability to adapt quietly in the background so that manufacturers, healthcare providers, and ultimately patients experience continuity rather than disruption.” 

An important context comes from Shimpi: “Alternate sourcing requires quality checks, documentation, validation, customer approval, qualification, change control, and regulatory discipline. For customers, resilience must not mean uncontrolled substitution. It must mean pre qualified, compliant, and approved alternatives.” 

The pharma supply chain operates within a regulatory framework that does not allow for quick substitutions, even under pressure. Companies that move too fast on alternate sourcing without following the required steps may create compliance problems that are harder to resolve than the original supply issue. 

Sustainability amid disruption 

The industry was already working through sustainability commitments when the geopolitical pressures intensified. For pharma packaging, the two objectives: supply continuity and reduced environmental impact do not always point in the same direction. 

Dr Roomi reflects, “The industry also needs to balance both sustainability and continuity. Eco friendly packaging is very significant, but it should be practical, compliance and scalable during the essential conditions of supply. Future ready pharma packaging also requires those material which are safe, cost efficient and adaptable to continuous changing regulations.” 

Garg is straightforward about the specific challenge pharma faces: “When it comes to sustainability goals, the answer is slightly more complex for the pharma industry. In many other sectors, it is comparatively easier to reduce or eliminate the use of single-use plastics. However, in pharma, where sterility and minimal exposure are critical requirements, it becomes far more difficult to completely move away from plastic-based packaging materials.” 

Srivastava notes that sustainability and logistics are now being looked at together rather than separately: “We are also seeing a meaningful shift in sustainability thinking. Packaging design, weight optimisation, emissions, and transport modes are no longer being evaluated independently. Companies are increasingly viewing them as interconnected decisions that influence both environmental performance and long-term supply chain resilience.” 

The longer-term picture 

The current disruptions have brought to the surface a structural issue: India’s domestic packaging material manufacturing capacity has not kept pace with the country’s pharmaceutical ambitions. This gap is something companies are now more directly aware of. 

Garg points to the plastics sector as a specific area that needs attention: “India needs to improve both the quality and availability of pharmaceutical-grade plastics. I believe this is one area where the industry is still lacking. At present, there is one major corporation manufacturing high-quality plastic materials, but even they are not always able to meet the volumes required by the market. Apart from them, very few players can consistently match the same quality standards. There is a strong need for greater investment in the plastics manufacturing sector, along with government support to encourage the growth of more companies in this space.” 

Shimpi points to the role of digital systems: “Digital tools and digital manufacturing will play a major role in building early risk visibility and faster response capability. Stronger systems for demand sensing, inventory visibility, supplier monitoring, logistics tracking, scenario planning, real time operational visibility, advanced quality systems, and data led decision making can help companies respond before disruption reaches the customer.” 

Kapoor frames the investment case in terms of India’s next growth opportunity: “Estimates show that 118 biologics will lose patent protection between 2025 and 2034, opening a $232 billion to $234 billion biosimilar opportunity. It has also been reported that biologic drugs with more than $300 billion in global sales are set to lose patent protection over the next decade. India has recognised this shift through Biopharma SHAKTI, a Rs 10,000 crore, five-year initiative to strengthen biologics and biosimilars, with an ambition to capture 5 per cent of the global biopharma market. To make this real, India must localise the critical enabling layer: specialty films, sterile bags, tubing, connectors, filters, cold-chain systems and traceable packaging formats. Future-proofing will come from validated localisation not basic import substitution.” 

Prasad highlights, “For Indian pharma companies, packaging functions must evolve from a transactional role to a strategic pillar of supply chain resilience. Proactive diversification, localisation, innovation, and long-term planning will be essential to ensure uninterrupted supply, regulatory compliance, and product integrity in an increasingly uncertain global environment.” 

The road ahead 

The geopolitical pressures affecting pharma packaging are unlikely to ease quickly. Supply chain dependencies built over many years will take time to reconfigure. Regulatory frameworks in destination markets will continue to evolve. Input costs will remain linked to global energy and commodity markets. 

Srivastava is clear about what the long-term response needs to look like: “Looking ahead, resilience must become a built-in capability rather than an emergency response mechanism. Diversifying sourcing geographies for critical packaging inputs, strengthening regional supply networks, and reducing dependency on single trade corridors will be essential for long-term stability. We are already seeing companies reassess traditional supply models and create greater redundancy across both procurement and logistics functions.” 

Chakraborty summarises where the industry stands: “Indian pharma is being squeezed by higher costs, shipping delays, and stricter compliance. Short-term resilience comes from buffer stocks, agile logistics, and supplier diversification, while long-term stability requires local manufacturing, smart packaging, and trade alliances.” 

Shimpi puts the collaboration agenda plainly: “Pharma companies and packaging partners must work more collaboratively. Early demand visibility, faster approvals for alternate sources, transparent cost discussions, and joint risk planning will be essential to protect medicine availability in an increasingly uncertain world.” 

Reddy makes the case for treating packaging as a strategic function: “Standardise internal master data so you are mandate-agnostic; insist on interoperable, exportable serialisation data so no single portal or vendor can strand you; wargame disruptions the way other industries run continuity drills; and elevate compliance from a cost centre to a board-level resilience function. India’s advantage as the world’s pharmacy will, over the next decade, be defended less at the chemistry bench and more in the packaging hall, where physical integrity and digital traceability meet.” 

The current situation has made clear that packaging is not just a downstream activity. It carries supply risk, cost risk, compliance risk, and in the longer run, competitive risk. How the industry responds to that reality including how much it invests in building domestic capacity and better supply chain structures will shape its ability to meet export commitments and grow in regulated markets over the years ahead. 

Kalyani.sharma@expressindia.com 

journokalyani@gmail.com

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Introduction: Moving beyond conventional QbD

Quality by Design (QbD) has become a cornerstone of pharmaceutical development by enabling a structured, science- and risk-based approach to formulation and process design. Regulatory frameworks such as ICH Q8 and ICH Q9 emphasize linking critical quality attributes (CQAs) to formulation and process variables to ensure consistent product performance.

However, as formulations become more complex, traditional QbD approaches—largely dependent on Design of Experiments (DoE)-face practical limitations. These include challenges in capturing non-linear interactions, increasing experimental burden, and limited ability to predict outcomes beyond defined experimental spaces.

Artificial intelligence (AI) tools, particularly artificial neural networks (ANN), offer a complementary approach by enabling predictive, data-driven modeling. Integrating ANN within QbD frameworks provides an opportunity to move from empirical development toward a more efficient and predictive paradigm.

“AI-enabled QbD is transforming pharmaceutical development from experimental optimization to predictive, data-driven design.”

Hybrid QbD–AI framework

A hybrid QbD–AI approach integrates structured experimentation with advanced modeling to improve formulation understanding and optimization. In this framework, initial DoE studies generate experimental data that are used to train ANN models. These models extend the design space, identify complex relationships, and support virtual optimization of formulation variables. Experimental confirmation then validates predictions, enabling robust and scalable formulation design.

“The integration of artificial neural networks within QbD enables the identification of complex, non-linear relationships that traditional models fail to capture.”

Hybrid QbD–AI workflow (practical view)

1. Define QTPP and CQAs

2. Run initial DoE screening to generate structured data

3. Train ANN on curated formulation/process datasets

4. Predict and refine the design space

5. Confirm with targeted validation runs

6. Establish control strategy and monitoring plan (PAT-enabled)

Figure 1. Hybrid QbD–AI framework for formulation development. Integration of traditional QbD elements with AI-driven modeling enables predictive design space expansion, optimized formulation selection, and robust control strategy development.

A comparative summary of traditional and AI-enabled QbD approaches is provided in Table 1

Table 1. Comparison of Traditional QbD vs AI-Enabled Hybrid QbD Approaches

“The integration of AI into QbD enables a shift from experimental optimization to predictive and knowledge-driven formulation development.”

Application example

In a representative application aligned with previously published work (Singh et al., 2026), artificial neural networks (ANN) were integrated within a QbD-guided formulation development strategy to optimize a multi-component modified release tablet system. Initial DoE studies were conducted to evaluate key formulation variables and their influence on CQAs. The resulting dataset was used to train ANN models capable of capturing non-linear relationships not fully described by conventional statistical approaches.

In the published study, the ANN model showed excellent predictive performance, with generalized R² values of 0.9989 (training), 0.9999 (validation), and 0.9988 (test), supporting reliable optimization of polymer ratios and modified-release performance.

These findings highlight the practical value of integrating AI within QbD frameworks to enhance formulation robustness, scalability, and development efficiency.

“Hybrid QbD–AI approaches significantly reduce experimental burden while improving formulation robustness and scalability.”

“AI models enable expansion of the design space beyond experimental boundaries, enhancing predictive confidence.”

Figure 2. Comparison of Traditional QbD and AI-enabled Hybrid QbD approaches.

Impact on manufacturing and scale-up

AI-guided models improve scale-up predictability by quantitatively linking critical material attributes (CMAs) and critical process parameters (CPPs) to CQAs across scales. By identifying process sensitivities and non-linear interactions, these models enable more robust design space definition and support control strategy optimization. Integration with process analytical technology (PAT) further allows data-driven monitoring and reduces variability during scale-up, technology transfer, and commercial manufacturing.

AI models should be managed under lifecycle governance (e.g., version control, retraining criteria, and audit trails) to support sustainable deployment within a pharmaceutical quality system.

“AI-guided formulation development improves scale-up predictability and reduces risk during commercialization.”

Practical adoption checklist (industry-ready)

• Use structured DoE to generate high-quality training data and avoid bias in factor coverage.

• Define CQAs and acceptance criteria before model training (QTPP-driven).

• Validate ANN predictions using an independent confirmation set before expanding the design space.

• Translate model outputs into a control strategy and monitoring plan (PAT where appropriate).

• Maintain model governance through documentation, change control, and periodic performance review.

Analytical procedures supporting PAT, release, and stability testing should follow science- and risk-based development and validation principles consistent with current ICH guidance (e.g., ICH Q14 and ICH Q2(R2)).

Conclusion

Hybrid QbD–AI approaches represent a significant advancement in pharmaceutical development, enabling more predictive, efficient, and robust formulation design. By integrating AI with established QbD principles, these approaches improve understanding of complex formulation–process relationships, enhance design space definition, and support robust control strategies across development and manufacturing. As pharmaceutical systems become increasingly complex, AI-enabled QbD frameworks offer a practical pathway toward more informed, efficient, and reliable product development.

“The future of pharmaceutical R&D lies in converging QbD principles with AI-driven predictive modeling.”

References

1. Singh, P.K., Kumar, V., Parihar, A., et al. AI-Powered Predictive Modeling to Optimize Pharmaceutical Formulation and Precise Drug Delivery in Modified Release Tablets. Journal of Pharmaceutical Innovation. 2026; 21:52. https://doi.org/10.1007/s12247-025-10283-2

2. International Council for Harmonisation (ICH). ICH Q8(R2): Pharmaceutical Development. Final version (Step 4), August 2009. https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf

3. International Council for Harmonisation (ICH). ICH Q9(R1): Quality Risk Management. Final version (Step 4), adopted 18 January 2023. https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2022_1219.pdf

4. International Council for Harmonisation (ICH). ICH Q10: Pharmaceutical Quality System. Final version (Step 4), 4 June 2008. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf

5. International Council for Harmonisation (ICH). ICH Q14: Analytical Procedure Development. Final version, adopted 1 November 2023. https://database.ich.org/sites/default/files/ICH_Q14_Guideline_2023_1116.pdf

6. International Council for Harmonisation (ICH). ICH Q2(R2): Validation of Analytical Procedures. Final version, adopted 1 November 2023. https://database.ich.org/sites/default/files/ICH_Q2%28R2%29_Guideline_2023_1130.pdf

(Paritosh Singh is a pharmaceutical R&D leader with extensive expertise in advanced drug delivery and AI-driven formulation development, leveraging Quality by Design (QbD), statistical modeling, and machine learning to develop robust and scalable pharmaceutical products. He is recognized for original and impactful contributions to the application of artificial intelligence in formulation science, with influence across multiple development programs. He has held critical scientific roles within global pharmaceutical organizations, including Jubilant, Johnson & Johnson, and Perrigo. He serves as a reviewer for leading scientific platforms, including AAPS and the Journal of Controlled Release, and as an international award judge, including AOAC scholarship panels, reflecting peer recognition of his expertise and contributions to the field.)

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It is expected to close in the third quarter (Q3) of 2026, pending regulatory approvals and shareholder consent from Crinetics.

The transaction adds two main endocrinology assets to Vertex’s portfolio.

Crinetics’ Palsonify (paltusotine), a once-daily oral therapy for adults with acromegaly, was approved by the US Food and Drug Administration (FDA) in September 2025 and also by the European Medicines Agency (EMA) in April 2026.

Acromegaly is a rare condition usually caused by a pituitary tumour that leads to excess growth hormone secretion.

The company’s pipeline also includes atumelnant, a once-daily oral adrenocorticotropic hormone receptor antagonist in Phase III development for congenital adrenal hyperplasia (CAH).

CAH is a chronic genetic disorder characterised by impaired cortisol synthesis and excess androgen production.

Vertex has stated that the acquisition is anticipated to contribute to its revenue growth from the ongoing launch of Palsonify, and that atumelnant, if approved, could also generate significant revenue in CAH and potentially in Cushing’s syndrome.

The two assets together are projected by the companies to have a combined annual peak sales potential exceeding $5bn.

Vertex intends to fund the acquisition with a mixture of cash on hand and debt, supported by a fully committed bridge financing of $4.5bn from Bank of America and Morgan Stanley Senior Funding.

Vertex CEO and president Reshma Kewalramani said: “Crinetics is an excellent strategic fit for Vertex, with its focus on serious diseases in speciality markets with significant unmet need, well-understood causal human biology, and potentially best-in-class medicines that could deliver transformative benefit to patients.

“We are also excited by the significant potential of atumelnant to transform the treatment landscape for CAH, setting a new standard of care where patients do not have to choose between managing their excess adrenal androgens and enduring the side effects of high-dose steroids.”

In April 2026, Halozyme Therapeutics’ subsidiary Halozyme Hypercon signed a global exclusive partnership and licence agreement with Vertex for the Hypercon technology.

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These results showed that the combination reduced the risk of disease progression or death by 79% versus R² alone. Patients treated with the Tepkinly-based therapy achieved an overall response rate of 96%, compared to 81% for those receiving R².

Complete response (CR) rates reached 74% for patients receiving the combination, with 181 out of 243 patients achieving this outcome. For those treated with R² alone, the CR rate was 43%, with 106 out of 245 patients achieving a CR.

The safety profile observed in the trial was consistent with the known characteristics of the individual treatments.

The most frequent adverse reactions, occurring in 20% or more of patients, included anaemia, constipation, Covid-19, cytokine release syndrome (CRS), diarrhoea, fever, hypogammaglobulinaemia, neutropenia, pneumonia and thrombocytopenia.

Serious adverse reactions were reported in 44% of patients receiving the combination. CRS, pneumonia, Covid-19, and febrile neutropenia were among the events affecting at least 5% of participants.

AbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar said: “This approval is important because it brings an effective treatment option to patients across Europe, representing meaningful progress for patients with follicular lymphoma.”

Epcoritamab is a subcutaneous IgG1-bispecific antibody developed using Genmab’s DuoBody technology.

It is being co-developed by AbbVie and Genmab and is approved for certain lymphoma indications in more than 65 territories, under the names Epkinly in Japan and the US, and Tepkinly in the European Union.

The companies are investigating further uses of epcoritamab, alone and in combination, for various haematological malignancies in clinical trials.

Last month, AbbVie agreed to acquire Apogee Therapeutics for $10.9bn, potentially further fortifying its legacy in the immunology space and marking another sizeable investment into the disease area as it garners notable big pharma interest.

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Introduction

India is often described as the “pharmacy of the world.” Yet, the growing menace of counterfeit and substandard medicines poses a serious threat to public health, consumer safety and India’s pharmaceutical credibility.

Recent incidents involving adulterated cough syrups, oxytocin-related deaths, fake Mounjaro injections and large-scale counterfeit medicine seizures are not isolated violations. They point to a deeper systemic problem: counterfeit medicine is no longer merely a regulatory offence. It is an organised criminal enterprise involving illegal manufacturing, forged documentation, interstate supply chains, financial fraud, corruption and, increasingly, digital distribution.

Despite the seriousness of the offence, conviction rates in counterfeit drug cases remain extremely low. Investigations often stop at seizure and prosecution of retailers or wholesalers, while manufacturers, financiers, transporters and masterminds escape scrutiny. The Drugs and Cosmetics Act, 1940, by itself, is inadequate to address the scale and complexity of such organised networks.

The Delhi–Agra–Puducherry investigation, unfolding between 2025 and 2026, provides an important investigative model. It demonstrates how coordinated action by Drug Inspectors, police, Special Task Forces, CDSCO, State Drug Departments and the pharmaceutical industry can expose the full supply chain — from retail seizure to illegal manufacturing units.

Delhi: The value of police–drug inspector coordination

The Delhi investigation began with intelligence received by the Delhi Drugs Control Department. Acting with the assistance of Delhi Police, Drug Inspectors conducted a raid at a residential premises in Paschim Vihar, where counterfeit medicines worth crores were allegedly stocked and distributed.

The key significance of the Delhi case was its legal and investigative approach. The matter was not treated only as a violation under the Drugs and Cosmetics Act. Investigators also examined offences relating to cheating, forgery and criminal conspiracy.

This marked an important shift. When Drug Inspectors and police work together from the beginning, they are better placed to preserve documentary, digital, financial and forensic evidence. The Delhi investigation showed that an apparent local seizure could, through proper backward tracing, reveal links to illegal manufacturing units in Puducherry.

The lesson is clear: every counterfeit medicine seizure must trigger both backward and forward tracing. Investigators must identify the source of manufacture, distribution channels, transporters, financiers, beneficiaries and the larger criminal network.

Agra: Following the supply chain

The Agra investigation took the matter to a larger scale. In August 2025, Uttar Pradesh STF, FSDA and Agra Police uncovered a major counterfeit medicine syndicate. Counterfeit medicines worth more than ₹5 crore were reportedly recovered. Fake invoices, GST irregularities, cloned QR codes and interstate supply chains were also detected.

Unlike conventional enforcement actions, investigators did not stop with the seizure. They examined transport records, GST documents, warehouse operations, digital communications and movement of consignments across states. This approach led them to the same manufacturing source in Puducherry.

The Agra case also revealed the financial strength and audacity of such networks. During the enforcement action, one of the main accused allegedly offered ₹1 crore to investigating officials to stop the proceedings. Instead of derailing the investigation, this resulted in an additional case under the Prevention of Corruption Act.

This episode reinforces two important points. First, counterfeit medicine networks often possess substantial illicit financial power. Second, attempts to obstruct or influence investigations must be prosecuted firmly, as they form part of the organised crime ecosystem.

Puducherry: Reaching the manufacturing source

The most significant breakthrough came when evidence from Delhi and Agra led enforcement agencies to illegal manufacturing facilities in Puducherry.

Teams from Delhi Police, Drugs Control Department, Agra Police and FSDA travelled to Puducherry to pursue leads. Their efforts, along with joint operations by CDSCO and the Puducherry Drugs Control Department, uncovered clandestine units allegedly manufacturing counterfeit medicines in the names of reputed pharmaceutical companies.

Large quantities of counterfeit medicines, packaging material, holograms, empty capsules, manufacturing machinery, forged labels and other incriminating material were seized. The investigation also revealed the use of shell entities, fake invoices, forged QR codes and interstate logistics to move counterfeit products into North Indian markets.

This stage of the investigation confirmed that Delhi and Agra were not isolated cases. They were linked to a wider interstate manufacturing and distribution network. Several units were sealed, licences were cancelled and financial transactions came under scrutiny.

The Puducherry investigation shows that effective enforcement cannot end at the retail or wholesale level. To dismantle counterfeit medicine networks, investigators must reach the source of manufacture, disable production infrastructure, expose financial channels and identify all participants in the supply chain.

Multi-agency coordination changed the investigation

A defining feature of the investigation was coordinated action between Drug Regulatory Authorities, State Police, Special Task Forces, CDSCO and the pharmaceutical industry.

This coordination allowed agencies to connect cases that may otherwise have remained isolated. Industry support also played a crucial role. Pharmaceutical companies helped authenticate seized products, identify counterfeit packaging, verify QR codes, examine trademarks and establish whether the seized goods were genuine or fake.

Such cooperation transformed routine regulatory inspections into organised crime investigations.

Recognising the interstate ramifications of the case, the Hon’ble Lieutenant Governor of Puducherry directed that the matter be transferred to the Central Bureau of Investigation for a wider probe into the criminal conspiracy. This makes the case particularly significant in the context of counterfeit medicine enforcement in India as the first of its kind investigation handed over to the CBI.

From counterfeit medicines to corruption

The investigation also exposed the link between counterfeit medicine and corruption.

During the CBI probe, attempts were allegedly made to influence the investigation through illegal gratification. This led to the arrest of intermediaries, a Delhi Police Inspector and, subsequently, a senior IPS officer in connection with an alleged bribery conspiracy.

A similar attempt had earlier surfaced during the Agra investigation, where an accused allegedly offered ₹1 crore to investigating officers.

These developments show that organised pharmaceutical crime does not stop at illegal manufacturing. It can extend into bribery, obstruction of justice, financial crime and attempts to compromise enforcement agencies through their ill-gotten financial prowess.

Legal lesson: A drugs case alone is not enough

One of the strongest lessons from the Delhi–Agra–Puducherry investigation is that counterfeit medicine cases should not be investigated only under the Drugs and Cosmetics Act.

Every such case may also involve cheating, forgery, criminal conspiracy, trademark infringement, copyright violation and organised financial crime. Therefore, investigators should examine offences under:

• The Drugs and Cosmetics Act, 1940;
• The Bharatiya Nyaya Sanhita;
• The Trades Marks Act;
• The Copyright Act;
• The Information Technology Act;
• The Prevention of Corruption Act, where applicable;
• GST laws and financial statutes;
• The Income Tax violations;
• The Prevention of Money Laundering Act, where proceeds of crime are involved.

Counterfeit medicines are not merely illegal products. They are instruments of fraud. They deceive consumers, damage genuine brands, endanger public health and generate unlawful profits.

Financial investigation must therefore proceed in parallel. Investigators should examine bank accounts, GST records, ITRs, shell companies, benami assets, transport payments, digital wallets and suspected proceeds of crime. Where appropriate, the Enforcement Directorate should examine money-laundering dimensions.

Only an integrated legal strategy can ensure that the entire network — not merely the person in possession of counterfeit stock — is prosecuted.

The Mounjaro Case: The next stage of counterfeit crime

The fake Mounjaro case illustrates the changing nature of pharmaceutical crime.

Counterfeit medicine is no longer limited to conventional tablets and capsules. It now includes sophisticated biologics, injectable products, imported raw materials, forged labels, online marketing and digital supply chains having national and international ramifications.

In Avi Sharma v. State of Haryana, relating to the Mounjaro counterfeit case, the accused sought bail on the ground that he had cooperated with the investigation and that no direct recovery was made from his possession. It was also argued that the matter was merely a complaint under the Drugs and Cosmetics Act involving an experimental product. The defense did raise very many procedural lapses during the hearing which will cost the case heavily during the trial.

The Court, however, noted prima facie material indicating the manufacture and distribution of spurious medicines using forged labels and counterfeit branding of an international pharmaceutical company. Considering the public health risk, bail was declined.

The case reinforces the need for future investigations to combine cyber investigation, forensic examination, financial intelligence and pharmaceutical expertise.

The way forward

The Delhi, Agra and Puducherry investigations show that counterfeit medicine networks can be dismantled when enforcement is intelligence-led, evidence-based and coordinated.

India must move away from treating counterfeit medicine as a routine regulatory violation. It must be treated as organised crime affecting public health, market integrity and national credibility.

Future investigations must institutionalize joint operations between Drug Inspectors and police from the very beginning of the case. Every seizure should be followed by mandatory backward and forward supply-chain tracing so that investigators identify not only the person in possession of counterfeit medicines, but also the source of manufacture, transporters, distributors, financiers and end beneficiaries.

Investigations must also move beyond the Drugs and Cosmetics Act alone. Appropriate provisions relating to cheating, forgery, criminal conspiracy, trademark infringement, copyright violation, organised crime and corruption should be invoked wherever applicable. This wider legal approach is necessary because counterfeit medicine cases involve deception, brand misuse, public health risk and unlawful financial gain.

Forensic examination should become a routine part of such investigations. Packaging material, labels, QR codes, holograms, batch numbers, digital devices, transport records and financial documents must be scientifically examined to establish linkages between accused persons, locations, products and transactions.

A parallel financial investigation is equally essential. Bank accounts, GST records, shell entities, benami assets, logistics payments and proceeds of crime must be scrutinized. Where the proceeds of crime are identifiable, appropriate action under money-laundering laws should also be considered.

Data analytics must be used to identify repeat offenders, counterfeit medicine hotspots, targeted brands and recurring supply-chain patterns. Industry cooperation is also crucial, as pharmaceutical companies can assist enforcement agencies in product authentication, verification of packaging, identification of counterfeit labels and technical analysis of cloned QR codes or trademarks.

In cases involving interstate syndicates, central agency involvement should be considered at an early stage. Coordinated action between regulators, police, financial intelligence agencies and the pharmaceutical industry is necessary to dismantle the entire organized network rather than merely seize the counterfeit stock.

In this context, IPA’s proposed “Nautilus Counterfeit Medicine Databank” is a timely initiative. By collating information from FIRs, seizure reports, news articles and enforcement records, such a databank can help identify repeat offenders, map crime hotspots, detect targeted brands, track frequently counterfeited medicines and link persons, places, objects and events across cases.

The data already indicates that several accused have been involved in multiple offences across the country. Such repeat offenders must be investigated under appropriate provisions dealing with organised crime and criminal networks. BNS section 111 and 107 should be invoked.

The National Human Rights Commission’s recognition of counterfeit medicine as a human rights issue and the Bureau of Police Research and Development’s national-level training programmes further underline the urgency of the issue.

Conclusion

The Delhi–Agra–Puducherry investigation is a turning point in counterfeit medicine enforcement. It shows that when investigators go beyond seizure and follow the evidence, they can uncover the full criminal architecture behind fake medicines.

Counterfeit medicine is not a minor regulatory lapse. It is organised crime involving public health endangerment, forgery, cheating, financial fraud, corruption and interstate criminal networks.

The future of enforcement lies in coordinated investigation, data-driven intelligence, forensic support, financial scrutiny and strong industry–law enforcement cooperation. Only such a multidisciplinary approach can protect consumers, preserve public health and dismantle organised counterfeit medicine networks in India.

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It is expected to close in the second half of 2026, pending customary closing conditions and regulatory approvals.

Myricx Bio is developing antibody-drug conjugates (ADCs) that target cancer cells using N-myristoyltransferase inhibitor (NMTi) payloads.

These next-generation payloads are designed to address limitations of commonly used ADC payload classes such as topoisomerase 1 (TOPO-1) inhibitors.

The company’s pipeline includes two lead candidates directed at the tumour-associated targets B7 homologue 3 (B7-H3) and human epidermal growth factor receptor 2 (HER2), indicating potential application across various solid tumour types.

Novartis biomedical research president Fiona Marshall said: “ADCs have become an important part of cancer treatment, but there remains a clear need for new payload mechanisms to overcome resistance and expand their impact for patients.

“Myricx Bio has developed a promising NMTi payload platform with a differentiated mechanism that could broaden the use of ADCs across multiple tumour settings.

“This proposed acquisition reflects our strategy to scale innovative platforms, as we have with radioligand therapies, to deliver more durable, transformative treatments for patients.”

Based on preclinical data, the NMTi payloads may display broad activity across solid tumours, including those resistant to existing therapies such as TOPO-1 inhibitors.

The agreement would enable Novartis to assist in establishing NMTi, pending clinical validation, as a new class of ADC payloads that could be used for a variety of targets and platforms.

Prior to this, the European Commission granted approval for Novartis’ Itvisma (onasemnogene abeparvovec) as a treatment for children two years and older, teenagers and adults who have 5q spinal muscular atrophy with a bi-allelic mutation in the survival motor neuron 1 gene.

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Besins Healthcare will acquire UniD’s site in Seraing, Belgium. A total of 52 employees will also be transferred to the company.

The transaction will see UniD Manufacturing rebranded as Besins Healthcare PharmTech, which is intended to become a centre dedicated to future innovation and development projects.

Besins Healthcare has developed hormone therapies for both men’s and women’s health, including products such as Estrogel / Oestrogel (estradiol), Utrogestan (micronised progesterone) for women, and Androgel / Testogel (testosterone) for men.

UniD Manufacturing adds capabilities for developing drug delivery systems intended to enable less frequent administration of treatments.

Besins Healthcare co-CEOs Nicolas and Alexandre Besins said: “This acquisition unites two teams with deep and complementary expertise, and we couldn’t be more pleased to welcome UniD to Besins Healthcare. This is a natural partnership for both companies, and we are excited about what lies ahead.”

UniD Manufacturing executive chairman Marc Foidart said: “We are proud of what the UniD team has built over the past 20 years, and we are delighted to see those capabilities take on a new dimension as part of Besins Healthcare.

“The UniD team looks forward to innovating further with Besins Healthcare, as well as continuing to serve our existing clients with the same commitment they have always received.”

The companies have not disclosed the deal value.

In the immediate future, UniD Manufacturing will continue its current operations and service to existing clients.

Besins Healthcare operates in 114 countries through 22 subsidiaries.

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Immuneel Therapeutics, India’s pioneering cell and gene therapy  company, announced a strategic partnership with Arogya Finance to introduce India’s first  Zero Cost EMI program of up to ₹25 lakhs for eligible patients undergoing treatment with  Qartemi (Varnimcabtagene autoleucel), Immuneel’s CD19-directed autologous CAR-T cell  therapy.

The collaboration marks a significant milestone in improving patient access to advanced cancer  care by addressing one of the most critical barriers to treatment—timely affordability. The  partnership has been formalized through a collaboration agreement under which Arogya Finance  will independently provide financing to eligible patients, while Immuneel continues to focus on  delivering world-class CAR-T therapy.

For patients with relapsed or refractory B-cell malignancies, CAR-T cell therapy is often considered  after conventional treatment options have failed. While these patients are fighting against time,  families are frequently faced with another challenge—arranging substantial funds within a matter  of days. For many, this financial burden can delay treatment at a stage where every day is clinically  important.

Recognising this unmet need, Immuneel has introduced the Saksham Patient Access Program,  under which eligible patients can now avail Zero Cost EMI financing of up to ₹25 lakhs for a tenure  of up to 12 months, subject to credit assessment, lender approval and applicable terms and  conditions. The initiative has been designed to ensure that financial constraints do not become a  barrier to accessing potentially life-saving therapy.

Amit Mookim- Chief Executive Officer, Immuneel Therapeutics said “Innovation in healthcare is  meaningful only when patients can access it. While tremendous progress has been made in  developing advanced cellular therapies, affordability remains a significant challenge for many  families. Through this partnership with Arogya Finance, we are addressing a critical unmet need  by helping eligible patients access Qartemi without the burden of arranging the entire treatment  cost upfront. This is another important step towards making advanced cancer care more  accessible in India.”

Under the program, every patient first undergoes a comprehensive medical evaluation by  Immuneel’s Medical Affairs team to determine eligibility for CAR-T cell therapy. Eligible patients  are then supported through the Saksham Desk, which provides dedicated financial counselling  and facilitates the financing process. Upon submission of the required documentation, loan  applications are independently evaluated by Arogya Finance, enabling rapid processing so that treatment planning can proceed without unnecessary delays. The financing arrangement is  independently administered by Arogya Finance, which is solely responsible for loan approval,  disbursement and servicing.

Jose Peter, Co-founder & Chief Executive Officer, Arogya Finance added “At Arogya Finance, we  believe that access to quality healthcare should not be limited by immediate financial constraints.  We are proud to partner with Immuneel to introduce an innovative financing solution that enables  eligible patients to access one of the most advanced cancer therapies available today while easing  the financial burden on their families.”

Qartemi (Varnimcabtagene autoleucel) is Immuneel’s CD19-directed autologous CAR-T cell  therapy developed for eligible patients with relapsed or refractory B-cell malignancies. As India  continues to strengthen its capabilities in advanced cell and gene therapies, improving patient  access through innovative financing models will play an increasingly important role in ensuring  that medical innovation translates into meaningful patient outcomes.

The Zero Cost EMI initiative reinforces Immuneel’s commitment to democratizing access to  advanced cellular therapies through innovation, affordability and patient-centric care. By  combining scientific excellence with access solutions, the company continues to work towards  ensuring that eligible patients can receive timely treatment when they need it the most.

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The Federation of Pharma Entrepreneurs (FOPE) has sought clarifications from the Central Drugs Standard Control Organization (CDSCO) on the implementation of pharmacovigilance (PV) requirements under the revised Schedule M, citing ambiguities that could lead to inconsistent interpretation and compliance across the pharmaceutical industry.

In a representation addressed to the Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, FOPE requested detailed guidance on the implementation of Paragraph 6.11 of the revised Schedule M following a CDSCO circular issued on June 3, 2026, directing stakeholders to establish and maintain an effective pharmacovigilance system in accordance with the Drugs and Cosmetics Act, 1940, the revised Schedule M and the New Drugs and Clinical Trials (NDCT) Rules, 2019.

The industry body, which represents pharmaceutical manufacturers with a strong focus on MSMEs, said regulatory clarity is essential to ensure uniform implementation by manufacturers, marketers and licensing authorities.

One of the key issues highlighted by FOPE relates to pharmacovigilance responsibilities in third-party or contract manufacturing arrangements. Under Paragraph 6.11 of the revised Schedule M, licence holders are required to maintain a pharmacovigilance system for collecting, processing and forwarding reports of adverse drug reactions arising from drugs “manufactured or marketed by the licensee.”

FOPE has requested CDSCO to clarify whether this responsibility should rest with the manufacturing licence holder or the marketing company whose name appears on the product label. The association argued that where products are manufactured under contract and marketed by another company, the marketer should be considered responsible for pharmacovigilance obligations, as marketers are already responsible for product quality under the Drugs Rules, 1945.

The representation also seeks clarification on the distinction between the general pharmacovigilance requirements prescribed under Schedule M and the Periodic Safety Update Report (PSUR) requirements under the NDCT Rules, 2019. FOPE noted that while Schedule M appears to mandate a pharmacovigilance system for all marketed products, PSUR submissions under the NDCT Rules are specifically linked to new drugs.

The association has therefore requested CDSCO to clarify whether Schedule M requires only a general pharmacovigilance system for marketed products, while PSUR submissions remain applicable exclusively to new drugs as defined under the NDCT Rules.

A third issue raised by FOPE concerns the applicability of the NDCT Rules, 2019 to products approved before the Rules came into force. The association has sought clarification on whether PSUR obligations apply only to new drugs approved after 2019 or whether they are intended to cover products that received regulatory approval prior to the commencement of the NDCT Rules.

FOPE said such clarifications would help manufacturers, marketers, State Licensing Authorities and CDSCO’s zonal offices adopt a consistent approach towards pharmacovigilance compliance. The association has urged the regulator to issue suitable guidance to facilitate uniform implementation of the revised Schedule M provisions across the pharmaceutical sector.

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A couple of recent notifications, one a notified amendment and the second one, a proposed amendment, concerning medicines have good intentions, but could have quite the opposite outcomes. While regulators are playing their role to rationalise restrictions, with the mandate to improve Ease of Doing Business, they have to also balance patient safety and public good.

Let’s first take a recent instance of authorities stepping in to investigate and if necessary, enforce anti-dumping duties on specialised packaging material. A recent LKS International Trade Team update informs about the Directorate General of Trade Remedies (DGTR) acting on a complaint from JPFL Films and initiating an Anti-Dumping Duty investigation concerning imports of Biaxially Oriented Polyamide (BOPA) film originating in and exported from China PR and Thailand.

As per the LKS International Trade Team update, BOPA films are high-performance specialised flexible packaging films manufactured from polyamide resin through biaxial orientation technology, known for its high mechanical strength, isotropic properties, odour and aroma resistance, hot and cold forming resistance, moisture and oxygen barrier properties, and puncture resistance.

BOPA film is used as specialised packaging material for food, liquids and pharma products. If the DGTR’s investigation finds that the imports of BOPA film from China PR and Thailand are at dumped prices and impacting the business of the domestic industry/company, then it can recommend anti-dumping duty, to rectify the harm to JPFL Films’ business. This case ties in directly to the crisis looming around pharma packaging, the theme of the cover story of Express Pharma’s July edition. (Resilience by Design: The Packaging Imperative).

Let’s now consider how some regulations could backfire. For instance, the Union Health Ministry has expanded the QR code-based drug traceability framework to include all vaccines, antimicrobials, narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, and anti-cancer medicines. 

This notified amendment to the Drugs Rules, 1945 to expand the ambit of Schedule H2 is expected to “facilitate authentication of medicines at various stages of the supply chain and enable improved tracking and verification of drug products. The measure is expected to strengthen regulatory oversight and support efforts to curb the distribution of spurious medicines in the market.”

But industry experts have pointed out that QR codes can be counterfeited, leading to a false sense of security among patients. (https://www.expresspharma.in/how-counterfeiters-are-breaching-indiasqr-code-system/) 

Manufacturers of vaccines, narcotic and psychotropic drugs, and anti-cancer medicines have a year to comply with this mandate while the provisions relating to antimicrobials shall become effective a year later, from July 1, 2028.

One hopes that regulators use the interim period to ensure that they have the taskforce and systems in place to enforce these mandates. This would, at the very least, entail more frequent surprise inspections and raids of vulnerable touch points within the pharma supply chain to make this initiative as impactful as it needs to be.

Secondly, let’s consider the Union Ministry of Health and Family Welfare’s proposal to rationalise/reduce the required residual shelf-life for imported drugs. The draft amendment proposes to revise the current requirement of a minimum residual shelf life of more than 60 per cent for imported drugs to 12 months at the time of import. Biological products and radiopharmaceuticals are exempted from this revision “in view of their specialised nature and public health considerations.”

On the face of it, this amendment has many advantages. The amendment is “expected to optimise supply management, reduce costs, and strengthen the availability of essential medicines in the country.” Patients are expected to get improved access to imported medicines, while importers of such medicines will get more time to distribute such medicines before expiry.

The proposed amendment is open for comments from industry till July 22, 2026. Industry response has been positive so far, as it seems to address supply chain issues and gives more time to sell imported medicines. 

But from a patient safety point of view, how many patients in India are aware expired medicines could have health risks? How many patients check expiry dates? Are expired medicines indeed taken out of the pharma supply chain at all? Especially imported medicines, which would be more expensive? Would the Ease of Doing Business mandate result in compromised patient safety? Especially when it would be difficult to test the quality of such imported medicines as they near their expiry dates.

There have been many reports of expired medicines being re-sold to patients. In fact, the illegal sale and disposal of expired medicines was the topic of a Lok Sabha question in March 2026 (Unstarred Question no. 4641) from Jai Prakash of the Hardoi constituency of Uttar Pradesh, Bharatiya Janata Party.

His query was quite detailed and reveals the modus operandi of such scams: ‘whether the Government has taken or proposes to take strict action to curb the illegal and dangerous practice of reselling expired medicines, which involves altering expiry dates and reentering them into the supply chain’; whether the Central Drugs Standard Control Organization (CDSCO) has issued new guidelines on the safe disposal of expired/unused drugs to ensure that they are not diverted back into the market; and whether the Government has launched “Drug Take-Bank” programmes, where consumers can drop off expired medicine at designated locations.

In her reply, Anupriya Patel, Union Minister of State for Health and Family Welfare, informed that CDSCO, with the approval of the Drugs Technical Advisory Board (DTAB) had issued a guidance document (on May 26, 2025) on the disposal of expired/unused drugs. She also informed that State Licensing Authorities ‘are legally empowered and take stringent actions against violation of provisions of the Act and Rules including the instances of reselling the expired medicines.’

This exchange proves that there is enough awareness among legislators and regulators on the extent and serious harm to consumer health posed by expired medicines, imported or manufactured in India. Whether these rules are implemented and enforced enough is another question.

There is no doubt that regulatory oversight has had some wins. The recent CDSCO advisory against ‘promotional activities, including so-called “awareness campaigns,” that function as a surrogate advertisement for prescription drugs including Glucagonlike peptide-1 (GLP-1) receptor agonists,’ was a timely reminder that what may work in other markets, may not be aligned to Bharat’s realities.

These recent amendments and reforms underline the fine line between reform and risk. Regulators like the CDSCO, Ministry of Health & Family Welfare have a tough balancing act: to bring in business efficiencies without compromising public health. Converting good intentions into impactful benefits for all stakeholders will need stringent implementation and enforcement. 

VIVEKA ROYCHOWDHURY,
Editor
viveka.r@expressindia.com
viveka.roy3@gmail.com 

The post The fine line between reform and risk  appeared first on Express Pharma.

Itvisma works by providing a functional copy of the SMN1 gene, which is deficient in people with SMA.

The therapy involves a one-off, fixed-dose intrathecal injection and does not require adjustments based on age or body weight.

The approval is supported by data from the registrational STEER trial, alongside results from the Phase IIIb STRENGTH and Phase I/II STRONG studies.

In the STEER study, Itvisma led to a statistically significant improvement of 2.39 points in the Hammersmith Functional Motor Scale, with this benefit maintained over a 52-week period.

Both the STEER and STRENGTH studies reported clinically meaningful benefits for patients, regardless of whether they were previously treated or treatment-naïve.

Novartis International president Patrick Horber said: “This approval marks a major milestone for people living with SMA. With Itvisma, we are going further to expand access to a one-time gene replacement therapy for older children, teens and adults – potentially addressing long-standing unmet needs for patients.”

Common side effects reported for Itvisma include upper respiratory tract infection, raised temperature, vomiting, headache and increased hepatic enzymes.

Novartis holds exclusive global licences related to the intravenous and intrathecal delivery of AAV9-based gene therapies for SMA.

In March 2026, Novartis received US Food and Drug Administration approval for Cosentyx (secukinumab) to treat paediatric patients aged 12 years and above with moderate to severe hidradenitis suppurativa.

The post European Commission approves Novartis’ Itvisma to treat SMA appeared first on Pharmaceutical Business review.

The initiative seeks to create a platform that uses AI to analyse a wide range of scientific, immunogenicity and clinical datasets produced during vaccine research.

It aims to aid researchers in making evidence-based decisions, especially around advancing to costly and lengthy Phase III clinical trials, a step complicated in several vaccine areas, such as rotavirus, due to lack of validated immune correlates and inconsistent assay results.

The ROTOR platform will initially be developed and validated using rotavirus vaccine datasets and experience from SK bioscience and PATH.

Project leaders aim to build a scalable solution that could later be applied across various vaccine types and disease areas.

According to SK bioscience, reusable elements of the platform could facilitate broader adoption in the vaccine development sector, particularly helping researchers in low- and middle-income countries.

The company noted that pharmaceutical firms typically rely on Phase II data to decide about progressing to large-scale Phase III studies.

By applying AI to extensive research datasets and integrating diverse evidence sources, the ROTOR platform is intended to generate structured insights to support vaccine development strategy.

SK bioscience has previously worked with international health agencies, such as the World Health Organization (WHO), Gavi, the Vaccine Alliance, and the US Centers for Disease Control and Prevention (CDC).

SK bioscience CEO Jaeyong Ahn said: “This project represents a new approach to reducing uncertainty in vaccine development through AI and enabling more scientific and efficient decision-making. Through this consortium, we aim to drive innovation in vaccine R&D while contributing to improved vaccine access worldwide.”

In May 2026, SK bioscience signed a vaccine technology transfer and manufacturing agreement with Colombia’s state-owned pharmaceutical company VECOL, becoming part of the country’s $260m vaccine localisation initiative.

The post SK bioscience to lead Gates Foundation-funded ROTOR project appeared first on Pharmaceutical Business review.

The Central Government has amended the Drugs Rules, 1945 to bring cell or stem cell-derived products, gene therapeutic products and xenografts under the ambit of the Centrally Licence Approving Authority (CLAA) framework, marking a significant regulatory step towards strengthening oversight of advanced therapies and emerging medical technologies.

The amendment expands the list of products that require joint oversight by the Central and State licensing authorities, ensuring uniform regulatory standards for complex biological products across the country. Until now, the CLAA framework covered specified categories such as vaccines, recombinant DNA (r-DNA)-based medicines and large-volume parenterals exceeding 100 ml.

With the latest amendment, advanced therapies including stem cell-based regenerative treatments, gene therapies and xenografts will now also be subject to central licensing approval alongside state-level regulation.

According to the government, the move is aimed at enhancing regulatory scrutiny of rapidly evolving technologies that are increasingly being used in the treatment of complex diseases.

Cell or stem cell-derived products, including CAR-T cell therapies, have emerged as promising treatment options for blood cancers such as leukaemia and lymphoma. Gene therapeutic products, including gene replacement and gene-editing therapies, are being developed for the treatment of inherited genetic disorders and several types of cancers. Xenografts, which involve the transplantation of animal tissue-derived products such as heart valves into humans, have found applications in cardiology and orthopaedics.

Given the complexity and specialised nature of these therapies, the government said enhanced regulatory oversight is necessary to ensure patient safety while supporting the adoption of innovative treatment modalities.

The inclusion of these products under the CLAA framework is expected to facilitate coordinated regulation between the Central and State Licensing Authorities, leading to greater consistency in licensing decisions and regulatory compliance across the country. The government said the amendment would strengthen India’s regulatory framework for emerging healthcare technologies while aligning it with evolving scientific developments and global best practices.

The move comes as India witnesses growing research and clinical interest in advanced therapy medicinal products, particularly in areas such as regenerative medicine, cell and gene therapies, and precision medicine. By bringing these products under a centralised licensing mechanism, regulators aim to ensure that quality, safety and efficacy standards keep pace with technological advancements.

The amendment also underscores the government’s broader efforts to modernise the country’s regulatory ecosystem to support innovation without compromising patient safety. Officials said the initiative reflects the government’s commitment to fostering the development and adoption of advanced healthcare technologies while maintaining robust regulatory safeguards.

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B&R, ABB’s Machine Automation division, announced the appointment of Pratip Samanta as new Regional Managing Director (RMD) for Southern and Eastern Asia, effective July 1, 2026. Pratip Samanta  succeeds Jhankar Dutta.  

Pratip brings over 21 years of leadership experience in Industrial Automation, IT Services, Digital Consulting, and Strategic Account Management. Most recently, he served as Global Client Partner at Tata  Consultancy Services (TCS) in Munich, where he drove strategic growth and large-scale digital transformation initiatives for global energy technology clients. He previously worked at ABB from 2008 to  2017 in several leadership roles across Sales, Consulting, and Operational Transformation, and brings  additional expertise from his tenure at Siemens in Automation & Drives, where he helped industrial  customers enhance operational efficiency and technological adoption. 

Pratip holds a Bachelor of Engineering from Vidyasagar University with focus on Electrical Engineering and attended TCS Emerging Leaders Program supported by Ohio State University and TATA Management Training Center.  

He succeeds Jhankar Dutta, who has decided to leave the company to pursue new career opportunities. 

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Shantha Biologics has entered into an outsourcing agreement with Novo Nordisk to provide cartridge fill-finish manufacturing services in India.

As per the press statement, the collaboration will be governed by the parties’ agreed contractual framework and carried out in accordance with applicable quality, compliance, and regulatory requirements. No financial terms or further details of the agreement were disclosed.

The agreement with Novo Nordisk reflects Hyderabad-based Shantha Biologics’ continued focus on high-quality manufacturing execution and its role as a trusted partner to global healthcare companies.  Shantha Biologics’ capabilities span vaccines, biologics, and specialised sterile manufacturing.

“We are pleased to enter into this collaboration, which reflects the confidence placed in Shantha Biologics’ capabilities and our commitment to reliable, high-quality cartridge fill-finish services,” said Dr. Vishy Chebrol, Director, Shantha Biologics. “We look forward to supporting this partnership through strong operational execution and a continued focus on quality and compliance.”

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The Department of Pharmaceuticals (DoP) has notified the Drugs (Prices Control) Amendment Order, 2026, introducing a series of amendments to the Drugs (Prices Control) Order (DPCO), 2013 aimed at improving regulatory clarity, easing compliance for pharmaceutical manufacturers and strengthening monitoring under the price control regime. The amendments came into effect on June 30, 2026.

Among the key changes is a provision allowing the government to notify separate ceiling or retail prices for the same scheduled drug based on pack size, packaging type, dosage compliance or formulation characteristics.

The notification also provides significant relief to manufacturers in cases involving overcharging. Under the amended Paragraph 14, a manufacturer’s liability will now be restricted to the stock traded through the specific distributor or retailer found to have overcharged, provided the manufacturer demonstrates compliance with the requirements under Paragraph 24 and other government guidelines.

In another important amendment, the DoP has simplified the pricing requirements for follow-on manufacturers launching an already approved new drug. Existing manufacturers introducing the same new drug within 12 months of the retail price fixation will no longer be required to seek fresh retail price approval. Instead, they must intimate the launch to the government in the newly introduced Form IA within one month of commercialisation. However, manufacturers launching products above the notified retail price will continue to be liable to deposit the overcharged amount along with applicable interest and penalties.

The amendments also introduce additional safeguards relating to price revisions. Manufacturers seeking protection from wider overcharging liability will be required to demonstrate that revised prices have been effectively communicated to dealers, retailers and consumers through multiple channels. These include circulating revised price lists within two weeks of notification, publishing advertisements in at least two national newspapers, issuing revised Forms V or VI, displaying updated prices on the company’s website and submitting batch-wise production and stock details at the time of price revision. In such cases, overcharging liability will be calculated only on the stock handled by the retailer, distributor or stockist found selling above the notified price.

Another notable amendment relates to record retention. Manufacturers will now be required to maintain records relating to active pharmaceutical ingredients, bulk drugs, formulations and sales for a minimum of seven financial years immediately preceding the current financial year. The records must also be preserved until the conclusion of any proceedings initiated under the DPCO, if applicable. The government will retain the authority to inspect these records whenever required.

The amendment further mandates manufacturers to furnish price lists and supplementary price lists to State Drug Controllers and the government with references to the relevant price fixation or revision notifications issued under the DPCO. It also formally introduces Form IA to facilitate mandatory reporting of new drug launches, including information on formulation details, launch price, pack size and the latest government-notified retail price.

The latest amendments are expected to improve operational clarity for manufacturers while reinforcing transparency and compliance within the country’s drug pricing framework.

The post DoP amends DPCO 2013 to ease compliance, clarify overcharging liability appeared first on Express Pharma.

The post From packaging to patient outcomes: Why India’s latest DPCO amendment signals a new direction for pharmaceutical care appeared first on Express Pharma.

Takeda will take the lead in advancing selected candidates through clinical validation, using its global development capabilities.

The partnership aims to identify drug candidates with the potential for clinical differentiation across Takeda’s main therapeutic areas.

By applying advanced AI models in early-stage drug design, both companies aim to enhance the selection process for candidate molecules and focus on achieving criteria related to efficacy and safety.

Insilico will receive about $60m in fees, near-term payments, and milestones upon project initiation.

The deal also includes the possibility of further preclinical, clinical, commercial, and sales milestone payments, which could bring the total value up to approximately $600m.

Insilico is also set to receive tiered royalties on any future sales resulting from the collaboration.

The agreement gives Takeda exclusive global rights to develop, manufacture, and commercialise new therapeutics that emerge from the drug discovery programme.

Insilico Medicine founder, CEO and CBO Alex Zhavoronkov said: “I am excited to partner with one of the top leaders in the biopharmaceutical industry with massive competence in generative AI.

“As we deepen the integration of generative AI into every stage of the pharma value chain, I believe the future of pharmaceutical superintelligence has the potential to deliver the highest quality and differentiated drugs. This is a fundamental step on our journey toward extension of healthy productive life.”

Earlier this year, Insilico Medicine announced several AI drug discovery collaborations with China Medical System (CMS) across several projects in central nervous system (CNS) and autoimmune diseases.

The post Insilico Medicine, Takeda partner on AI-driven drug discovery appeared first on Pharmaceutical Business review.

Additionally, the whole genome sequencing (WGS) capabilities of Inocras will be integrated into AimedBio’s antibody-drug conjugate (ADC) clinical programmes.

The post Inocras, AimedBio team up for cancer treatments appeared first on Pharmaceutical Business review.

The Ministry of Health and Family Welfare has released the draft National Pharmacy Commission (NPC) Bill, 2026 for public consultation, proposing a comprehensive overhaul of India’s pharmacy education and professional regulatory framework by replacing the nearly eight-decade-old Pharmacy Act, 1948.

The proposed bill seeks to modernise pharmacy education, strengthen professional standards, improve institutional oversight and create a transparent, technology-driven regulatory ecosystem aligned with evolving healthcare and industry needs.

The draft bill proposes the establishment of the National Pharmacy Commission as the apex regulatory body for pharmacy education and practice. It envisages competency-based education, a National Exit Test (Pharmacy) for registration, a live digital National Register of Pharmacy Professionals, periodic assessment and rating of pharmacy institutions, and stronger ethical and professional standards. It also proposes dedicated boards for pharmacy education, institutional assessment and registration to streamline governance and improve accountability. Stakeholders have been invited to submit comments on the draft within one month.

The proposed reforms have received an encouraging initial response from industry.

The Federation of Pharma Entrepreneurs (FOPE) has welcomed the government’s move, describing it as a landmark reform that could significantly strengthen India’s pharmacy ecosystem.

Harish Jain, National President, FOPE, said, “FOPE welcomes the Government of India’s initiative to modernize the pharmacy regulatory framework through the proposed National Pharmacy Commission Bill, 2026, replacing the Pharmacy Act, 1948. This is a landmark reform that has the potential to align pharmacy education and professional regulation with the evolving needs of the healthcare system and the pharmaceutical industry.

“The emphasis on competency-based education, a National Exit Test, digital registration, transparent assessment of pharmacy institutions, and stronger ethical standards are progressive measures that can enhance the quality and global competitiveness of India’s pharmacy profession.”

While endorsing the overall direction of the reforms, FOPE has urged the government to ensure that the final legislation adequately reflects the perspective of the pharmaceutical manufacturing sector.

Jain said, “However, FOPE believes that the final legislation should also ensure meaningful representation of the pharmaceutical manufacturing sector, particularly MSMEs, in policy formulation and implementation. The practical experience of industry is critical in shaping pharmacy education, industrial pharmacy, skill development, regulatory compliance, and research.”

FOPE has also called for a smooth transition from the existing regulatory framework, highlighting the need to safeguard the interests of currently registered pharmacists and promote stronger collaboration between academia and industry.

“We also urge the Government to provide a smooth transition from the existing regulatory framework, protect the interests of currently registered pharmacists, strengthen industry-academia collaboration, and ensure that implementation is phased, practical, and consultative,” Jain added.

The industry body said it will undertake a detailed review of the draft legislation before submitting its recommendations to the Ministry during the consultation period.

“FOPE will study the draft Bill in detail and submit comprehensive recommendations to the Ministry within the consultation period. We remain committed to working with the Government to build a modern pharmacy ecosystem that promotes patient safety, quality education, innovation, and the sustainable growth of India’s pharmaceutical sector,” Jain said.

The Ministry is expected to finalise the legislation after examining stakeholder feedback received during the consultation process.

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Glenmark Specialty S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals (Glenmark) announced the advancement of its multi-country Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811), a HER2-targeted antibody drug conjugate (ADC), for patients with platinum-resistant ovarian cancer (PROC).

India will serve as the first country in Glenmark’s licensed markets to initiate patient enrollment for the Phase 3 clinical trial, following the approval of Drugs Controller General of India (DCGI). Glenmark also plans to enroll patients in Australia and South Korea, subject to regulatory approvals.

The study is aligned with Jiangsu Hengrui Pharmaceuticals’ ongoing parent Phase 3 trial in China. Glenmark aims to generate clinically relevant data across broader and more diverse patient populations, supporting the development of Trastuzumab rezetecan across Glenmark’s licensed markets. The randomized, controlled, multi-centre, Phase 3 trial is designed to evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab rezetecan in patients with HER2-expressing platinum-resistant ovarian cancer, a difficult-to-treat disease where treatment options remain limited, and outcomes continue to be poor. Conducting the trial across multiple geographies is expected to support the generation of evidence from diverse patient groups and strengthen the clinical data package for the therapy across Glenmark’s licensed markets.

Commenting on the announcement, Dr Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals Limited, said, “Advancing this pivotal Phase 3 trial marks an important step in Glenmark’s journey to build a differentiated oncology pipeline for global markets. Platinum-resistant ovarian cancer remains an area of significant unmet need, and the initiation of patient enrollment in India, with additional countries planned, reflects our commitment to developing novel targeted therapies for patients with hard-to-treat cancers and limited treatment options. This study also strengthens our ability to generate clinically relevant evidence across diverse populations.”

Ovarian cancer remains one of the most challenging gynecologic malignancies globally. It is the eighth1 most common cancer among women worldwide. India carries a significant burden, ranking among the countries with the highest number of ovarian cancer cases and deaths globally. Many patients with advanced ovarian cancer treated with available platinum-based therapies develop recurrence and subsequently platinum resistance. This underscores the need for continued clinical development of targeted therapies that may improve treatment options for patients with advanced and resistant disease.

In September 2025, Glenmark entered into an exclusive collaboration and license agreement with Jiangsu Hengrui Pharmaceuticals (“Hengrui Pharma”) for Trastuzumab rezetecan (SHR-A1811), securing rights to develop and commercialize the asset across multiple markets. Under the agreement, Glenmark holds exclusive rights worldwide excluding Mainland China, the Hong Kong SAR, the Macao SAR, Taiwan Region, USA, Canada, Europe, Japan, Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan and Uzbekistan.

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Resilience By Design – The Packaging Imperative
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Click to download: July 2026 Digital Magazine

Three individuals allegedly bought expired medicines at scrap prices, relabelled them with professionally printed stickers, repackaged them, and pumped them back into the pharmaceutical supply chain. This incident is a stark reminder that expired medicines are not merely a regulatory concern—they are a patient safety hazard. Yet, barely a week later, the Ministry of Health and Family Welfare (MoHFW) proposed making it easier to import medicines much closer to their expiry dates.

The timing could not have posed a more uncomfortable question: can a pharmaceutical supply chain already struggling to keep expired medicines off pharmacy shelves safely accommodate medicines entering the country with substantially less shelf life remaining?

Parsing the proposal

On 22 June 2026, the MoHFW published draft amendments to Rule 31 of the Drugs Rules, 1945,(1) replacing the existing requirement that imported drugs retain at least 60 per cent of their total shelf life with a flat requirement of 12 months’ residual shelf life. Under the current regime, a medicine with a total shelf life of 36 months can be imported only if approximately 21.6 months remain before expiry. The government argues that the proposed change would reduce wastage, improve the availability of medicines, simplify customs compliance, and promote ease of doing business by aligning India more closely with international supply chains.(2)

Those objectives are legitimate. But they rest on an assumption that India’s pharmaceutical supply chain functions efficiently enough for medicines with shorter remaining shelf lives to safely reach patients. That assumption merits closer examination.

One size does not fit all

The draft notification identifies reduced wastage and improved availability as its objectives but does not quantify the extent to which the existing 60 per cent rule has constrained imports or affected medicine availability.

The amendment exempts biological products and radiopharmaceuticals, and rightly so. Biologicals are temperature-sensitive and have variable shelf lives, while radiopharmaceuticals are susceptible to radioactive decay and may have shelf lives ranging from only a few hours to a few days.

Notably, many medicines with similarly short or unstable shelf lives are conspicuously absent from the list of exceptions. These include allergen extracts used for diagnostic testing and immunotherapy, which may have total shelf lives of only 9–18 months;(3) certain enzyme preparations with comparatively short stability periods;(4) and other biologically derived products that may lose potency much earlier than conventional medicines.

The proposed change also overlooks the slow turnover of inventory movement in India. Transportation of imported medicines from foreign manufacturers typically takes 3–15 days by air and up to 2–4 weeks by sea. Customs clearance and regulatory verification by drug control authorities may take another week. Thereafter, medicines are stored in warehouses and distributed through wholesalers over a period of six to eight weeks before finally reaching hospitals or retail pharmacies, where dispensing depends on patient demand. A medicine imported with only twelve months of residual shelf life may therefore reach a patient with less than eight months remaining before expiry. In slower-moving supply chains, particularly in smaller towns, rural markets, or low-demand therapeutic categories, medicines may reach consumers when they are already close to expiry—or even after becoming expired.

Perils of post-dated pills

Twenty-six years ago, the People’s Union for Civil Liberties filed a complaint against the Gobind Ballabh Pant Hospital, alleging that doctors administered expired medicines to patients, resulting in 26 deaths.(5) An expert committee subsequently found serious lapses on the part of the hospital administration.

This is not merely a story of the past. In June this year, an 11-year-old girl in Talabaruda village in Odisha’s Banspal block allegedly died after consuming an expired medicine obtained from an Auxiliary Nurse Midwifery Centre to treat fever. In another reported case from February 2026, a six-month-old infant died in Hyderabad suspectedly after consuming an expired medicine.

These incidents reflect a broader reality. Medicine users are often not vigilant about checking expiry dates. An empirical study conducted in rural Tamil Nadu found that approximately 30–60 per cent of consumers did not check the expiry dates of medicines before use.(6)

Time to regulate based on realities

Expired medicines may not merely result in reduced therapeutic efficacy. Many undergo significant degradation and changes in chemical composition over time. In time-sensitive conditions or among vulnerable patients, diminished efficacy alone can have serious clinical consequences. In other critical therapies, the use of expired medicines may also result in serious adverse health outcomes.

Ease of doing business is an important regulatory objective. But medicines are not ordinary consumer goods. Patients consume them with the expectation that they will be safe, effective and capable of treating illness. They must therefore retain their therapeutic quality throughout the supply chain.

India cannot afford to facilitate the circulation of near-expiry medicines when supply chains remain lengthy, consumer awareness of expiry dates is limited, and unscrupulous actors continue to exploit expired medicines for profit.

A more balanced regulatory approach would classify medicines according to their stability profiles, therapeutic risks and supply-chain realities rather than replacing one uniform rule with another.

While regulators deliberate on the proposed amendments and stakeholders submit their comments, the central question remains: what deserves pride of place on India’s pharmaceutical policy shelf—ease of doing business or patient safety?

Endnotes

1. Ministry of Health and Family Welfare, Government of India. Draft Notification: Amendment to Rule 31 of the Drugs Rules, 1945. Gazette of India (Extraordinary), 22 June 2026. Available at: https://egazette.gov.in/WriteReadData/2026/273833.pdf.

2. Press Information Bureau, Government of India. “Draft Amendment to Rule 31 of the Drugs Rules, 1945.” Ministry of Health and Family Welfare. Available at: https://www.pib.gov.in/PressReleasePage.aspx?PRID=2278097®=48&lang=1.

3. Cox LS, et al. “Allergen Immunotherapy: A Practice Parameter Third Update.” Journal of Allergy and Clinical Immunology, 2011. Available at: https://www.jacionline.org/article/S0091-6749(10)01566-6/fulltext.

4. Feller G. “Stability and Stabilization of Enzymes.” Advances in Enzymology and Related Areas of Molecular Biology, Vol. 67, 1993. Available at: https://www.sciencedirect.com/science/article/pii/000326709385082U.

5. Ferner RE. “Expired Medicines.” BMJ. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC1118495/.

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Mankind Pharma has announced a strategic collaboration with Denovo Sciences to launch an AI-led drug discovery programme, marking an important step in the company’s focus on innovation-driven and technology-enabled research and development.

The partnership will bring together Mankind Pharma’s strong R&D capabilities, experimental validation infrastructure, and clinical development expertise with Denovo Sciences’ proprietary platform for AI-driven molecular generation and prioritization. Together, both organisations will work under a human-in-the-loop model, where AI generates and evaluates molecular candidates while scientific experts guide, validate, and refine the results at every stage.

The collaboration is focused on three key goals: reducing early drug discovery timelines, improving the quality of lead candidates, and ensuring that only candidates with the strongest development potential move ahead. By using computational precision in the early stages of discovery, both partners aim to reduce the time and resources spent on candidates that may not succeed later. The long-term goal, as highlighted by both organisations, is to benefit patients. Faster discovery cycles and better candidate selection can help bring differentiated, effective, and accessible therapies to patients sooner.

“Drug discovery has always been a long and uncertain journey, and that uncertainty has real consequences for patients. Our collaboration with Denovo Sciences is about using the best available technology to make this journey faster and more precise. AI gives us the ability to explore a much larger molecular space than traditional methods, while the human-in-the-loop model ensures that scientific rigour remains central to every decision. This is the kind of R&D investment we believe will shape Mankind Pharma’s next chapter,” said Arjun Juneja, COO, Mankind Pharma.

“Artificial intelligence is significantly accelerating drug discovery timelines, particularly through emerging tools in generative chemistry, modular antibody design, and process optimization across the preclinical as well as clinical development value chain. Our entry into AI-driven drug discovery will position Mankind as one of India’s leading innovations-focused pharmaceutical companies,” said Dr Anil Koul, who leads innovation as company Group CSO.

“Partnering with Mankind Pharma is a natural fit for what we have built at Denovo Sciences. Our platform is designed to work alongside experienced drug discovery experts to generate better candidates, faster. Mankind Pharma brings deep R&D expertise and a strong commitment to making medicines more accessible. Together, we are using our proprietary AI technologies where they can create the greatest impact at the earliest stage of the discovery process, where the right decisions save the most time,” said Hovakim Zakaryan, CEO, Denovo Sciences.

For Mankind Pharma, this collaboration reflects a clear move beyond traditional drug discovery methods. The company has been expanding its R&D ambitions in recent years, and the partnership with Denovo Sciences represents its strongest step yet towards using AI as a core tool in the drug development process.

For Denovo Sciences, this collaboration represents a significant step in applying its proprietary technologies at scale with a leading pharmaceutical partner. It also supports Denovo Sciences’ broader goal of translating AI technologies into better drug candidates that can ultimately benefit patients.

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Cadila Pharmaceuticals, one of India’s leading integrated pharmaceutical companies, and Wellesta Holdings, Singapore, have signed a Memorandum of Understanding (MoU) to establish a strategic Joint Venture aimed at expanding access to high-quality healthcare solutions across South-East Asia and selected international markets. The partnership brings together the complementary strengths of both organisations. 

Cadila Pharmaceuticals contributes its extensive capabilities in research & development, manufacturing, regulatory compliance, and a diversified portfolio spanning prescription medicines, consumer healthcare products, and specialty therapies. With decades of pharmaceutical expertise and a strong vertically integrated business model, Cadila has established itself as a trusted healthcare partner across multiple global markets. 

Wellesta Holdings, headquartered in Singapore, is a fast-growing healthcare and pharmaceutical commercialization company with a strong presence across South-East Asia and other international markets. Through its established front-end infrastructure, market access capabilities, regulatory expertise, distribution network, and experienced commercial teams, Wellesta has successfully built and managed numerous healthcare partnerships across the region.

The proposed Joint Venture will focus on identifying and commercializing high-potential pharmaceutical and healthcare products, leveraging Cadila’s innovation and manufacturing excellence together with Wellesta’s market reach and commercialization strengths. The collaboration is expected to strengthen Cadila’s presence in key growth markets while enhancing Wellesta’s portfolio with differentiated and high-quality healthcare solutions.

The Joint Venture is envisioned as a strategic growth engine to expand business across South-East Asia, the Middle East, Africa, and other emerging markets. By combining Cadila’s product development and supply capabilities with Wellesta’s strong regional commercial footprint, the partnership aims to build a significant healthcare business over the coming years.

This collaboration reflects the shared commitment of both companies to improving healthcare outcomes through innovation, quality, and market excellence, while creating lasting value for patients, healthcare professionals, partners, and stakeholders.

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Roche today announced its second Digital Tech Hub in India, expanding its global Technology Hub network to Hyderabad alongside its existing site in Pune.  The new Tech Hub will be going live in the first quarter of 2027 and plans to scale up over the next few years.

“Hyderabad is a destination for an exceptional talent pool, especially for the Pharmaceutical and Life Sciences domain,” said Ramesh Durvasula,  Chief Data Officer and Chief AI Officer a.i.. “By tapping into India’s vibrant healthcare and technology  ecosystem,  we are creating scalable data-driven innovations to advance our core purpose of improving patient care.’’

On the development, Raja Jamalamadaka, Vice-President & Site Head, Roche Pune & Hyderabad Sites, shared; “Our investment in Hyderabad – a rapidly growing destination for research, technology and high-end innovations – reflects our long-term commitment to India and its ecosystem.” He further added: ”By scaling our footprint, we are enhancing our capability to orchestrate seamless, next-generation digital and technology solutions.”

The two Digital Technology Hubs in India will house teams delivering IT services and digital applications in areas such as Biostatistics, ERP, and Medical Safety. Hyderabad adds depth and capacity to the Life Sciences domain knowledge specifically tailored to accelerating the development of our digital solutions.

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Verzenios is a cyclin-dependent kinase 4 (CDK4) and 6 inhibitor that has received approval in China for several indications related to breast cancer.

Originally developed by Eli Lilly, it is approved in the country for use in combination with endocrine therapy as an adjuvant treatment for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence.

It is also indicated for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer.

In these settings, the therapy may be delivered in combination with an aromatase inhibitor, fulvestrant or imlunestrant.

Since 2021, Verzenios has been included in China’s National Reimbursement Drug List (NRDL) Class B, making it the first CDK4 and 6 inhibitor covered by national reimbursement.

Its renewal in the NRDL for 2025 provides continued coverage for both early and advanced breast cancer indications.

Innovent founder, board chairman and CEO Dr Michael Yu said: “Leveraging our established commercial infrastructure and strong market presence in China, we remain focused on addressing critical unmet needs in major oncology indications. Breast cancer, one of the most prevalent and life-threatening malignancies among women, is a strategic priority within Innovent’s oncology portfolio.

“Through this commercial collaboration with Lilly on Verzenios (abemaciclib) – backed by its robust clinical efficacy, comprehensive labelled indications and national reimbursement coverage – we are expanding our presence in this area, laying a solid foundation for our pipeline development and market expansion [to] deliver lasting benefits to patients in breast cancer.”

Last month, Eli Lilly entered a licensing agreement worth up to $1.26bn with Hanmi Pharm to develop, manufacture and commercialise Hanmi’s biologic drug candidate, sonefpeglutide (a LAPS GLP-2 analogue), worldwide, excluding Korea.

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The FDA did not raise concerns related to the clinical efficacy or safety data provided for the therapy, nor did it request new data from Unicycive.

Unicycive noted that the latest CRL is based on the same manufacturing issues identified in a previous CRL issued in June 2025.

As part of the current review process, the FDA has not yet conducted an inspection of the third-party manufacturer.

The NDA was resubmitted after Unicycive believed its manufacturer had made progress towards resolving previously cited deficiencies and demonstrating readiness for FDA inspection.

A Type A meeting between Unicycive and the FDA in September 2025 was held to discuss the status of the manufacturing vendor and to seek feedback on the company’s approach to addressing compliance concerns.

Unicycive reported that at that meeting, the FDA did not raise further issues or concerns regarding the third-party manufacturer’s remediation progress.

The NDA for OLC is supported by three clinical studies: a Phase I trial and a bioequivalence study in healthy subjects, and a tolerability study in patients with chronic kidney disease on dialysis, in addition to multiple preclinical studies and chemistry, manufacturing and controls data.

Unicycive CEO Shalabh Gupta said: “We remain confident in the efficacy and safety of OLC. We are in active and ongoing discussion with the FDA regarding label and packaging, and we are optimistic that there will be a successful inspection of the third-party manufacturing vendor and that we will be able to expeditiously resubmit the NDA.”

Unicycive is seeking approval for OLC via the 505(b)(2) pathway.

The therapy, which is described as an investigational oral phosphate binder, remains under FDA review and is currently protected by a global patent portfolio extending until 2031.

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Akums Drugs & Pharmaceuticals, India’s leading contract development and manufacturing organization (CDMO), has announced the launch of its DCGI-approved Pregabalin, Methylcobalamin and Duloxetine (Delayed Release) Capsules, a novel triple-action therapy for the management of diabetic peripheral neuropathic pain associated with Vitamin B12 deficiency.

Neuropathy is emerging as a significant public health concern in India, driven by the growing prevalence of diabetes and nutritional deficiencies. India is home to more than 100 million people living with diabetes, and studies suggest that nearly 25–50% of diabetic patients may develop neuropathy during the course of their disease. Vitamin B12 deficiency, reported in a large proportion of urban Indians, further contributes to symptoms such as tingling, numbness, fatigue, and cognitive changes, making effective management increasingly important.

Peripheral neuropathy is a progressive neurological disorder characterised by burning sensations, tingling, numbness, shooting pain, and loss of nerve function. If left unmanaged, it can lead to irreversible nerve damage, impaired mobility, sleep disturbances, and reduced quality of life. Early intervention and comprehensive treatment are therefore critical.

The newly launched formulation combines Pregabalin 75 mg, Methylcobalamin 1500 mcg, and Duloxetine 20 mg/30 mg (Delayed Release), bringing together three complementary therapeutic mechanisms. Pregabalin helps reduce abnormal nerve firing and provides relief from neuropathic pain symptoms. Duloxetine modulates central pain pathways by inhibiting serotonin and norepinephrine reuptake, while also supporting improvements in associated anxiety and sleep disturbances. Methylcobalamin, the neurologically active form of Vitamin B12, supports myelin sheath repair, improves nerve conduction, and aids in the regeneration of damaged nerve fibres.

A key differentiator of the therapy is its advanced dual-delivery technology, which enables the immediate and consistent release of Pregabalin and Methylcobalamin while ensuring targeted intestinal delivery of Duloxetine. This innovative design helps optimize the absorption profile of each active ingredient, supporting enhanced therapeutic effectiveness and patient comfort. The formulation is designed to promote therapeutic consistency, improve convenience, and encourage long-term treatment adherence.

Commenting on the launch, Sandeep Jain, Managing Director, Akums Drugs & Pharmaceuticals said, “India is witnessing a sharp rise in neuropathy cases driven by diabetes, nutritional deficiencies, and lifestyle disorders. Managing this condition requires more than symptomatic relief—it demands a holistic approach that supports nerve repair and long-term neurological health. Our triple-action formulation is a science-led innovation that combines multiple mechanisms into a single, patient-friendly dosage form to improve outcomes and adherence.”

He added, “As disease patterns evolve, there is a growing need for therapies that address multiple dimensions of patient care within a single treatment approach. This formulation combines pain management with nerve health support, offering clinicians a comprehensive option for neuropathy management while reinforcing our focus on developing differentiated and clinically relevant therapies for India’s healthcare needs.”

The CNS and neuropathy treatment market in India is expanding steadily, driven by increasing disease prevalence, improved diagnosis rates, and growing awareness among healthcare professionals and patients. Combination therapies are gaining prominence as they address multiple disease pathways while simplifying treatment regimens.

Indicated for diabetic peripheral neuropathic pain with co-existing Vitamin B12 deficiency, the formulation offers a differentiated option within the neuroscience segment. With this launch, Akums continues to strengthen its neuro-care portfolio and commitment to developing innovative, clinically relevant, and patient-centric therapies for India’s evolving healthcare landscape.

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Single-use bioprocessing has evolved from a tactical choice for speed and flexibility into a strategic pillar of modern biologics manufacturing. Yet one anxiety endures across process engineers, QA leaders, and supply chain executives alike: bag failures. Whether they occur at receiving, during gamma-aged storage, in a cold-chain handover, or mid-campaign at 2 a.m., the practical and financial consequences can be severe—lost batches, deviation cascades, contamination risk, and reputational damage. As titers rise, scales increase, and modality diversity explodes (mAbs, vaccines, CGT, RNA, and next-gen recombinant proteins), the reliability expectations placed on single-use bags are reaching parity with stainless systems—without compromising agility.

This article examines how the industry can engineer reliability into the next generation of single-use bags, focusing on seven critical levers: film selection, failure modes, seal integrity, mechanical stress, transportation studies, gamma aging, and bag qualification strategies. It closes with the strategic implications for both manufacturers and end users, and points to a set of core references for deeper study.

Why bag failures remain a major concern

Economic impact: A single drug-substance (DS) bag failure at 1,000 to 2,000 L—especially for high-value biologics—can translate to seven-figure losses and weeks of schedule slippage. Beyond direct material costs, the deviation investigation, CAPA, potential requalification, and regulatory exposure magnify the impact.

Complexity and variability: Bags are composite systems – polymer films, tie layers, EVOH or PVDC barriers, UV stabilizers, antioxidants, gamma stabilizers, fluid-contacting layers, ports, gaskets, and heat seals, assembled with process-specific hardware. Any weak link can become the initiating site for failure.

Scale and cumulative risk: Large DS fills (500 to 5,000 L) increase hydrostatic load, weld length, and handling complexity. The probability of an excursion somewhere across storage, shipping, staging, and processing grows with the number of touchpoints.

Regulatory and quality expectations: Agencies expect robust supplier oversight, material traceability, extractable/leachable control, contamination risk management, and change control. Bag integrity failures can trigger broader questions about supply chain robustness and patient safety.

Operating envelope expansion: Bags now see more extremes, i.e.,  -80 to -196 oC cold chains (frozen bulk, cryogenic hold), aggressive CIP-like detergents for pre-flush, long-term gamma-aged storage, elevated hold times, intensified mixing, and shipping under vacuum or pressure differentials.

Reliability, then, is not a single attribute—it is the emergent property of disciplined material science, manufacturing process control, mechanical design, logistics engineering, and lifecycle qualification.

Film selection: the foundation of reliability

Film architecture is the single most consequential determinant of bag performance. A modern film is a multilayer stack balancing five priorities: chemical compatibility, barrier performance, mechanical toughness, thermal behaviour, and radiation resistance.

The following are the important considerations while selecting single use.

Contact layer chemistry: Common choices for SU material is ULDPE/LLDPE for biocompatibility and weldability, sometimes metallocene-catalyzed grades for toughness. For solvents or surfactants (e.g., PS-80), the contact layer must resist swelling, environmental stress cracking, and additive extraction. Medical master batches and gamma stabilizers must be compatible; antioxidants (e.g., hindered phenols) mitigate oxidative embrittlement but can increase extractable if not controlled.

Barrier layer strategy: EVOH provides excellent oxygen barrier but is moisture-sensitive; humidity cycles during shipping can impact barrier properties and stiffness. PVDC has strong barrier properties but regulatory and sustainability headwinds; careful change control is essential if migrating away. Some “barrier-less” architectures lean on thicker polyolefins plus process controls; trade-offs include O2 ingress and CO2 retention in cell culture.

Mechanical reinforcement: Tie layers and outer layers define puncture and tear propagation resistance. Toughness must be maintained down to lowest-use temperatures (e.g., -80 C), where ductile-to-brittle transitions can occur. Notch sensitivity is crucial: slight cuts from hose barbs or handling fixtures can propagate under cyclic loading.

Thermal behaviour: Films must tolerate gamma-induced heat during sterilization and temperature excursions in transit. Glass transition and crystallinity profiles dictate low-temperature brittleness. For cryogenic applications, specialty elastomer-modified polyolefins or EVA blends can improve impact resistance.

Radiation stability: Gamma (25–50 kGy typical) drives chain scission and crosslinking. Formulation must target minimized embrittlement and controlled yellowing without raising leachable. Alternative sterilization (X-ray, e-beam) is emerging; however, cross-vendor comparability requires new validation as dose distribution and radical chemistry differ.

Supply continuity and change control: Dual-source resin strategies and pre-qualified alternates protect against upstream disruptions. Detailed resin lot traceability, certificate harmonization, and lock-step change notifications are essential to prevent “silent” film shifts.

For end users, the practical approach is a film selection rubric aligning the film to the application’s chemical, thermal, mechanical, and lifespan stressors; matched with supplier transparency on resin formulation, additive packages, sterilization dose mapping, and historical change logs.

Failure modes: know them to prevent them

Understanding failure mechanisms enables targeted design and qualification. High-frequency modes include:

1.     Incomplete fusion, cold seals, over-welded brittle zones, particulate occlusion in the weld, and misaligned multilayer stacks cause seal failure. These may pass low-pressure leak tests yet fail under thermal cycling or dynamic agitation.
2. Rigid port inserts create stiffness discontinuities, stress concentrates at the weld toe under bending, torsion, and impact during handling or mixing, hence special attention is required for port and weld interface.
3. Film stress cracking and brittle fracture is well known in SU. Low-temperature handling, gamma-aged embrittlement, or solvent exposure can initiate micro-cracks that accelerate under pressure cycles.
4. Abrasion from tubing clamps, transport vibration against pallet edges, trapped sharp particulates, or ice crystals in frozen storage can cause pinhole leaks.
5. Adhesion failures in multilayer structures due to poor tie-layer compatibility, humidity cycles (EVOH), or excessive thermal gradients during sealing cause delamination.
6. Silicone or TPE gasket set under compression creep; reconnect cycles erode sealing force. Mismatched connectors exacerbate. All these cause connector and gasket leakage.
7. Particulate ingress/foreign matter also a concern. Not a “leak” per se, but functionally a batch risk; sourced from film slitting, cutting, or outgassing residues adhering electrostatically.
8. Bioburden breach or sterile barrier compromise the bag integrity. Micro-channel defects that pass gross leak testing but fail sterile hold over time, especially under thermal/humidity cycling.

Failure is often multifactorial. A marginal seal plus gamma aging plus an unvalidated shipment profile is a disaster in combination. Robustness means stacking safety margins across multiple stressors simultaneously.

Seal integrity: where quality meets physics

Seals are typically the weakest structural feature because they alter polymer morphology, introduce geometric stress risers, and depend on process capability. It is important to engineering priorities, specifically process windows and controls. Seal need full characterization w.r.t. time-temperature-pressure windows using designed experiments. It is also essential to include film thickness tolerance extremes and study impact of humidity conditions.

It is essential to control and monitor real-time energy delivery in impulse sealing. Platen temperature uniformity and jaw pressure mapping is also essential. SPC on surrogate metrics (e.g., peel strength) guards against drift need precision control.

Seal geometry is critical. Wider seals distribute stress and stepped or multi-lane seals can localize and arrest tear propagation. It is known that smooth radii at corners reduce stress concentration. It is critical to avoid “knife edges” near port transitions.

Inline vision to detect inclusions/voids; HEPA-filtered sealing stations; anti-static controls to prevent particulate attraction require control and monitoring to assure cleanliness and occlusions.

To assure peel and burst, it is essential to use standardized peel tests (180°/T-peel) with acceptance criteria correlated to end-use loads. Burst tests should mimic realistic constraints (clamp points, temperature), and validation need to happen at initial and end-of-shelf-life after worst-case gamma and environmental aging. Moreover, port-to-film material compatibility (e.g., PP port with PE-based film) must ensure co-weldability without weak boundary layers.

For end users, supplier seal qualification data should be part of technical files, including histograms of seal strength, not just point estimates. On-receipt AQL sampling with statistically defensible plans (e.g., c=0, tightened inspection when supplier CPk drifts) adds assurance.

Mechanical stress: design for the real, messy world

Bags do not live in ideal test rigs. They are dragged across floors, overfilled, under-supported, and palletized next to heavier components.

Table 1: Mechanical reliability checks

Operational controls matter as much as design: SOPs for max stack height, corner protection, minimum support radius, and clamp placement reduce real-world excursions that formal testing may not fully capture.

Transportation studies: closing the gap between lab and logistics

Transit is a crucible for bag reliability. Temperature excursions, vibration spectra, shocks, altitude pressure changes, and handling practices vary widely across lanes and forwarders. When logistics are designed and qualified as deliberately as process steps, bag failure in transit becomes rare rather than routine for biopharma manufacturers.

Table 2: Where to pay attention for single-use shipping logistics

Gamma aging: the slow, invisible stressor

Irradiation is essential for sterility assurance, yet it initiates long-tail chemical changes in polymers that continue during storage. Gamma aging is manageable when treated as a design variable, not an afterthought.

During gamma exposure, chain scission reduces molecular weight and elongation-at-break, crosslinking become embrittle and radicals drive oxidative reactions if oxygen is present post-sterilization, additives (antioxidants, HALS, UV absorbers) quench radicals but can be consumed or transform into extractable species over time.

Industrial gamma cells produce dose gradients across pallets. Hence it is essential to validate performance at minimum and maximum mapped doses—both can be worst-case depending on mechanism. X-ray and e-beam can also present different dose-rate effects, hence do not assume interchangeability without data.

It is well know that elevated temperature and oxygen accelerate post-irradiation oxidation. Barrier packaging (e.g., aluminium over-pouch with oxygen scavenger) and cool, dark storage can extend mechanical life. It is essential to establish aging curves (e.g., Arrhenius-based accelerated aging) correlating to end-of-life properties: tensile, puncture, seal strength, and leak rate.

Gamma can increase low-MW species. Comprehensive extractable profiles at T0 and end-of-shelf-life, under relevant solvents (WFI, acids/bases, ethanol, PS-80), are table stakes. For high-risk modalities (cell/gene therapy), adopt science-based safety evaluations and clinically relevant leachable studies.

Manufacturers need to define sterilization dose range in the material specification, include acceptance criteria for mechanical properties at both dose extremes, initial and aged, and implement change control triggers for sterilization modality or supplier site moves; require requalification of both mechanicals and E/L.

Bag qualification strategies: from component to system

A robust qualification framework integrates material science with application-specific stressors. This lifecycle approach shifts reliability from reactive firefighting to proactive assurance.

Table 3: SU bag qualification strategy

Strategic value: why this matters to manufacturers and end users

For manufacturers (SU suppliers), publishing detailed film architectures, sterilization dose maps, and end-of-life mechanical curves builds trust and shortens customer qualification cycles, and offers differentiation through science and transparency. Investing in SPC on seal processes, advanced NDT leak screening, and route-specific packaging engineering reduces warranty claims and brand risk, which offers advantages related to cost of quality vs. cost of failure. Dual-resin strategies, second-source sterilization, and mirrored production cells in different regions de-risk geopolitical and logistics shocks, offering supply chain resilience. The future is about co-innovation with end users, where joint FEA, lane fingerprinting, and shared E/L toxicology models become sticky partnerships that outlast price cycles.

For end users (biopharma and CDMOs), reliable bags de-risk campaign schedules, increase OEE, and support intensified or continuous operations without buffer overstocking “just in case” offers significant advantage in terms of  operational continuity. Traceable, well-qualified single-use systems strengthen filings, reduce pre-approval inspection findings, and simplify post-approval changes offers regulatory confidence. Avoiding one DS batch loss can pay for multi-year reliability programs. Fewer excursions mean leaner deviation management and faster tech transfers, ultimately translating to financial resilience.  Standardized, qualified bag families enable global site harmonization, multi-modality flexibility, and faster on boarding of new processes offering platform scalability.

Reliability is not only a technical goal—it is a strategic enabler of speed, quality, and cost competitiveness.

Putting it together: a practical roadmap

It is important to define the operating envelope, to map fluids, temperatures, contact times, shear/mixing, fill heights, and logistics routes. This need to include future-state scenarios (e.g., scale-up, colder chains).

Always select film and design for context. Choose films aligned to chemistry and temperature; confirm gamma aging curves and E/L acceptability. Most importantly, engineer ports, seals, and geometries with FEA-informed stress diffusion that leads to a seal and port integrity control plan. Consider DOE for the sealing process; lock process windows with real-time controls; and validate peel/burst at T0 and end-of-life; include particulate controls.

Consider engineering logistics. It is important to qualify packaging via ISTA/ASTM plus lane-specific profiles, add corner protection, rigid containment, and shock/vibration damping as needed, validating altitude effects. Qualify it as a system – MQ/DQ the design and materials, IQ/OQ the hardware interfaces and process loads, and PQ at scale with worst-case conditions, including integrity testing.

Also monitor and improve. Implement incoming inspection AQL plans, defect taxonomy tracking, and CAPA loops. Requalify upon supplier or lane changes. Share data with your partner to prevent recurrence. It is also important to institutionalize change control where you need to pre-negotiate notice periods, comparability protocols, and parallel-lot strategies with suppliers. Maintain a living risk register tied to bag SKUs and uses.

Last but not least, the culture and training. Engineer-proof designs help, but trained operators prevent the majority of handling-induced defects. Consider using visual aids, do-not-bend zones, and hands-on practice with damaged exemplars.

Thoughtful advances on the horizon

Next-gen radiation sterilization is under consideration where in X-ray and advanced e-beam promise tighter dose control and less collateral polymer damage. It may result in new qualification paradigms and potential shelf-life gains.

Smarter films are under development where in formulations being tailored for cryogenic ductility without raising extractable; or oxygen-scavenging over-pouches; or embedded strain or breach-indicating inks.

Inline non-destructive integrity tests is are in near term horizon. High-sensitivity vacuum decay, acoustic resonance, or laser interferometry are being evaluated by the SU suppliers that could move QC from sampling to 100% screening for critical SKUs.

Digital twins are being considered for logistics. Predictive models fusing bag mechanics with real lane telemetry to recommend packaging configurations and even carrier selections seasonally are being developed.

Standardized data are being packed. Cross-supplier, regulator-endorsed templates for E/L, gamma aging, mechanicals, and seal capability that accelerate cross-qualification and reduce redundant testing packages are under development.

These innovations will raise the reliability floor while enabling even more ambitious process intensification and decentralized manufacturing models.

Conclusion

Single-use bags will remain central to bioprocessing’s agility and scalability, but the expectations have changed. Reliability must be engineered deliberately across film science, mechanical design, sealing processes, logistics, radiation effects, and comprehensive qualification. When suppliers and end users treat bag integrity as a shared, data-driven discipline—rather than a procurement line item—the risk of catastrophic failures diminishes, regulatory confidence grows, and manufacturing strategies become more resilient.

The future of single-use bags is not just tougher plastics or thicker films; it is a system-level commitment to quality by design, validated in the real world, and continuously improved through transparent partnerships. That future is within reach—and it is a strategic advantage waiting to be seized.

(Author: Priyabrata Pattnaik;  pattnaik.p@amipolymer.com)

References

• PDA Technical Report 66: Single-Use Systems for Pharmaceutical Manufacturing. PDA
• ASTM D4169-22: Standard Practice for Performance Testing of Shipping Containers and Systems. ASTM International
• ISPE Good Practice Guide: Single-Use Technology. ISPE
• BioPhorum (BPOG) Best Practices for Extractables Testing of Single-Use Systems in Biomanufacturing. BioPhorum
• PDA Technical Report 76: Consensus Method for Extractables and Leachables Risk Management in Biomanufacturing. PDA
• USP General Chapter <1665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. USP
• ISTA 3A: Packaged-Products for Parcel Delivery System Shipment 70 kg or Less. ISTA
• ISO 11137: Sterilization of Health Care Products—Radiation

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Morepen Laboratories issued an update on its recently announced Rs. 825 crore CDMO mandate. The first commercial dispatch, valued at approximately Rs. 50 crore, has already been completed by the company under the program during Q1FY2026-27. This marks the successful transition of the mandate from validation and qualification stage to commercial execution stage.

Commenting on the development, Sanjay Suri, Managing Director, Morepen Laboratories said, “This is an important milestone in Morepen’s transition toward long-duration global manufacturing partnerships. Our teams have worked closely with the customer through validation, manufacturing readiness and supply-chain planning. Having started execution of commercial supplies, we are focused on scaling up, expanding capacity and building a stronger CDMO platform across additional customer and product opportunities.” 

Having dispatched the first batch under the CDMO mandate, Morepen expects to scale the program further in the coming quarter, with additional supplies of approximately Rs. 225 crore expected during Q2FY2026-27, subject to customer schedules and regulatory/commercial requirements.

The Company continues to strengthen its manufacturing infrastructure to support larger CDMO opportunities. Total reactor capacity is expected to reach approximately 600 KL by the end of Q2, followed by further expansion toward 800 KL and 1,000 KL in subsequent phases.

The commencement of commercial supplies under this mandate reinforces Morepen’s strategy to build a scalable CDMO platform, deepen customer partnerships and participate in long-duration global manufacturing opportunities.

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The era of “make and hope” is dead. For decades, pharmaceutical manufacturing has been shackled to a retrospective model—a legacy system where quality is a post-mortem exercise conducted after a batch is already finished. This “old-fashioned” reliance on manual science and slow, physical trials creates a dangerous bottleneck. While patients wait for life-saving therapies, medicine sits in a state of regulatory limbo. We are now witnessing a paradigm shift: the transition from reactive testing to molecular precision. The futurist’s mandate is clear: we must stop checking for quality and start building it digitally before a single molecule is ever processed.

From manual science to digital design (QbDD)

We are evolving beyond traditional Quality by Design (QbD). While QbD was a noble attempt to define a Quality Target Product Profile (QTPP), it remained tethered to labor-intensive experiments. The future belongs to Quality by Digital Design (QbDD).

This shift represents a fundamental rewriting of the manufacturing roadmap:

• Process understanding: We are moving from physical experiments and risk assessments to a world of molecular modeling and predictive analytics.

• Data usage: The reliance on historical batch data and limited “designed experiments” is being rendered obsolete by massive volumes of real-time data from IoT sensors and AI-driven insights.

• Control strategy: We are replacing predefined rules and end-product “batch testing” with Process Analytical Technology (PAT) that allows for constant, adaptive adjustments.

By moving the lab into a virtual environment, AI simulations allow us to explore thousands of scenarios in seconds, ensuring that Critical Quality Attributes (CQAs)—such as purity and dissolution—are locked in with mathematical certainty.

The “virtual mirror” of the factory floor

The centrepiece of this revolution is the Digital Twin (DT). To understand its power, one must recognise that a static 3D model is merely a map—a snapshot of a moment in time. A Digital Twin, however, is the GPS: a living, breathing replica that accounts for real-time traffic, weather, and road conditions.

“A Digital Twin is a virtual replica of a physical system or process… constantly updated with real-time data from its physical counterpart, allowing for simulation, analysis, and optimisation throughout the product’s lifecycle.”

This “virtual mirror” provides a temporal advantage legacy systems cannot match:

• Predictive maintenance: The twin identifies machinery fatigue before the physical part even fails, eradicating unplanned downtime.

• Process optimisation: It simulates “what-if” scenarios for Critical Process Parameters (CPPs)—like mixing speed and reaction kinetics—to find the “Golden Batch” without wasting a milligram of raw material.

• Quality assurance: It ensures the process stays within its “Design Space” continuously, providing a lifetime of data rather than a single point of failure.

A nervous system of molecular “eyes and ears”

A Digital Twin is only as smart as its senses. This is where Process Analytical Technology (PAT) serves as the factory’s nervous system. Utilising high-tech observers like Near-Infrared (NIR) and Raman spectroscopy, the system monitors chemical and physical changes at the molecular level in real-time.

When the sensors detect a microscopic deviation, the system doesn’t trigger a shutdown; it initiates a “Sense-Analyse-Adjust” cycle. If moisture levels shift, the AI calculates the impact on the final dissolution rate and automatically adjusts the granulation temperature. This invisible calibration is the vital bridge to the ultimate goal: the end of the waiting period.

Killing the wait with real-time release testing (RTRT)

Traditional batch testing is a relic of an era that accepted inefficiency. In the old way, finished medicine sits in a warehouse for 14 days while scientists perform manual lab tests. For a patient waiting for a Narrow Therapeutic Index (NTI) drug, where minor deviations in concentration can mean the difference between therapy and toxicity, this delay is a clinical risk.

Real-Time Release Testing (RTRT) turns the manufacturing process itself into the final test. Because the system “knows” the quality is perfect the moment the process ends, the medicine can be shipped immediately. This is not just an efficiency gain; it is a clinical breakthrough that ensures life-saving Biopharmaceuticals reach the bedside the moment they leave the line.

Solving the sustainability paradox

The transition to AI is often criticised for its high energy cost, but digital twins are the key to “Green Manufacturing.” We are mitigating the carbon footprint of AI through Green Simulations—a process of reusing previously processed data rather than starting every simulation from scratch.

This digital integration addresses the sustainability paradox with hard data:

• 15–25 per cent increase in energy efficiency: Achieved through optimised, AI-driven production cycles.

• Up to 25 per cent reduction in material waste: Early detection by AI prevents defective batches from being fully processed.

• Decarbonising the supply chain: Advanced analytics optimise logistics and prevent overproduction, significantly lowering greenhouse gas emissions.

Conclusion: Building quality at the molecular level

The Digital Twin revolution is more than a technological upgrade; it is a moral imperative. We are moving from a world where we “check” for quality to a world where we build quality digitally at the molecular level.

By creating virtual mirrors of our factories, we ensure that medicine is of higher quality, kinder to our planet, and—most importantly—ready when the patient needs it. We must ask ourselves: How many patients are we willing to let wait while a perfect batch of medicine sits in a two-week quarantine, tethered to the “old-fashioned” rules of a pre-digital age? The future of medicine is virtual, and the time to build it is now.

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This specific composition-of-matter patent is exclusively licensed from US medical centre the Cleveland Clinic to Anixa, and addresses breast cancer, for which no preventive vaccine is currently approved worldwide.

The patent expands Anixa’s portfolio of intellectual property (IP) beyond the US and existing international markets.

The secured protection further supports its efforts to seek regulatory approvals, establish partnerships and explore future commercial opportunities.

Anixa Biosciences chairman and CEO Dr Amit Kumar said: “Each global patent we secure deepens the global foundation we are building for our breast cancer vaccine.

“As we continue clinical development in the US, our growing international patent estate further strengthens our ability to pursue global opportunities and potentially partner with larger pharmaceutical companies for worldwide commercialisation.

“In our recently completed Phase I clinical trial conducted at Cleveland Clinic, the vaccine met all major primary endpoints, was safe and well tolerated, and generated immune responses in 74% of participants, supporting continued clinical development of this novel preventive approach.”

The vaccine targets human α-lactalbumin, a protein associated with lactation that is abnormally expressed in certain breast cancer types.

This strategy, which focuses on immunising against so-called “retired” proteins, seeks to selectively activate the immune system to prevent tumour formation with minimal impact on normal tissue.

Anixa is evaluating this approach particularly in aggressive breast cancers such as triple-negative breast cancer.

The company describes its broader vaccine platform as aiming to address a range of high-incidence cancers.

Its development pipeline also includes an ovarian cancer immunotherapy, liraltagene autoleucel in partnership with Moffitt Cancer Centre, and other cancer vaccines in collaboration with the Cleveland Clinic.

The Cleveland Clinic is entitled to royalties and commercial revenues from these vaccine technologies.

In May 2024, Anixa Biosciences expanded its partnership with the Cleveland Clinic to develop additional cancer vaccines.

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Shareholders will also receive a contingent value right (CVR) entitling them to 80% of net proceeds from any future licence, divestiture or monetisation of ampreloxetine, should this occur within the next ten years.

Zymeworks will be entitled to the remaining 20% of such proceeds. If ampreloxetine is not monetised by the close of the transaction, a Theravance Biopharma designee will have up to 12 months post-closing to explore such opportunities on Zymeworks’ behalf.

The transaction follows a strategic alternatives review conducted by Theravance Biopharma’s Strategic Review Committee and Board of Directors, with Lazard acting as lead financial advisor.

The committee considered a range of options and previously oversaw the sale of the company’s Trelegy royalty interest for $225m in 2025, as well as scenario planning for clinical outcomes and a company restructuring.

Theravance Biopharma CEO Rick Winningham said: “We are proud of what Theravance Biopharma has accomplished over the past several years, including the successful development and commercialisation of Yupelri, which has become an important treatment option for patients with COPD [chronic obstructive pulmonary disease].

“Additionally, we continue to explore whether there is a path to bring ampreloxetine to patients with MSA [multiple system atrophy] and nOH [neurogenic orthostatic hypotension], a community with high unmet medical need. Our achievements would not have been possible without the dedication and commitment of our team, whose contributions helped the company reach this outcome and make a difference for patients around the world.”

The boards of both companies have unanimously approved the agreement, which remains subject to shareholder and regulatory approvals and is expected to close during the second half of 2026.

Financing includes a $350m note from OMERS Life Sciences and cash from both Zymeworks and Theravance Biopharma’s expected balances at closing.

In June 2025, China’s National Medical Products Administration conditionally approved Zymeworks’ zanidatamab for treating individuals with prior treated, unresectable or metastatic human epidermal growth factor receptor 2-positive biliary tract cancer.

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Aurobindo Pharma USA Inc. (APUSA), a wholly owned subsidiary of Aurobindo Pharma Limited, has completed its acquisition of Lannett Company, Inc., USA from Lannett Seller Holdco, Inc., following approval from the US Federal Trade Commission on June 18, 2026.

The company made the announcement in a disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, with reference to its letter dated June 19, 2026, and press release dated June 22, 2026.

Effective June 29, 2026, Lannett has become a wholly owned subsidiary of APUSA and will operate as Lannett Company LLC.

According to the company, the integration process will commence immediately, with a focus on ensuring uninterrupted access to critical medications, maintaining relationships with partners, and supporting employees during the transition.

The company stated that, by combining capabilities and resources, the organisation aims to enhance the availability of essential medicines and deliver long-term value to patients, customers and stakeholders.

APUSA also stated that it has welcomed more than 400 Lannett employees into its organisation, adding to its talent base and operational capabilities.

The company further stated, “We extend our sincere appreciation to Lannett’s management team for their leadership in enabling a smooth transition, as well as for their valuable contributions to the organisation.”

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Union Minister of Health and Family Welfare, Shri Jagat Prakash Nadda, has launched the Drug Registry, a digital platform for drug-related information, to standardise medicine data across healthcare systems in India.

According to the Ministry of Health and Family Welfare, medicines are among the most critical data elements in healthcare delivery. However, the same drug is often represented using different names and formats across healthcare systems in India, leading to inconsistencies, duplication, data entry errors and lack of interoperability. The ministry stated that these issues create challenges in clinical decision-making, e-prescriptions, supply chain management and continuity of care.

The Drug Registry has been conceptualised under the Ayushman Bharat Digital Mission (ABDM) and serves as a single source of truth for medicines in India. According to the ministry, it enables consistent identification, storage, exchange and usage of drug data across healthcare systems.

The ministry stated that ABDM is building a digital health ecosystem through four core registries: the ABHA Registry for individuals, the Healthcare Professional Registry (HPR), the Health Facility Registry (HFR) and the Drug Registry for medicines.

The Drug Registry has been developed in collaboration with the Central Drugs Standard Control Organization (CDSCO) and the National Resource Centre for EHR Standards (NRCeS), Pune. It uses international standards, including SNOMED CT, to support interoperability and semantic consistency across platforms.

According to the ministry, the registry includes standardised drug codes covering generic clinical drugs, branded medicines and substances.

The Drug Registry currently comprises more than 123,000 branded drugs, 10,000 generic drugs and 29,000 substances.

The platform enables users to search and identify drugs using generic name, brand name, substance and manufacturer.

According to the ministry, the Drug Registry has been built on standardised terminology aligned with global standards to support data exchange across healthcare systems.

The registry is designed to integrate with Hospital Management Information Systems (HMIS), e-prescription platforms, doctor-facing applications and ABDM-compliant digital health solutions. It also provides open APIs for integration across India’s digital healthcare ecosystem and connects healthcare providers, digital applications and citizens to a verified drug database.

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It did not identify concerns about the clinical efficacy or safety of NASP that would affect its potential for approval.

Sobi has stated that it intends to request a meeting with the FDA to discuss the feedback, consider the necessary steps for resubmission and work closely with contract manufacturing organisations (CMOs) to address the outlined deficiencies.

Sobi chief medical officer Lydia Abad-Franch said: “We continue to believe strongly in NASP’s potential to address the significant unmet need faced by people living with uncontrolled gout. The clinical data generated to date have demonstrated meaningful reductions in serum uric acid levels in patients with uncontrolled gout.

“The FDA’s feedback provides a clear and actionable path forward and we will work closely with them towards a resubmission. We remain committed to bringing NASP to patients.”

NASP is a sequential, two-component infusion therapy administered every four weeks.

It combines tolerogenic nanoencapsulated sirolimus, designed to reduce the formation of anti-drug antibodies, with pegadricase, a uricase that lowers serum uric acid levels.

The treatment is being investigated for its potential to help people with uncontrolled gout, a form of inflammatory arthritis that affects around 200,000 individuals in the US, who continue to experience high uric acid and debilitating flares despite oral therapies.

In December 2025, Sobi signed an agreement to acquire US-based biotechnology company Arthrosi Therapeutics, a move that will expand Sobi’s presence in the gout treatment market.

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Following this recommendation, the Jaypirca application moves to the European Commission (EC) for a decision, expected within the next one to two months.

Results from the BRUIN CLL-313 and BRUIN CLL-314 studies supported the application.

Lilly Oncology executive vice-president and president Jacob Van Naarden said: “Based on the strong results from the BRUIN CLL-313 and CLL-314 studies, we believe Jaypirca has the potential to serve as a meaningful new option for newly diagnosed patients and those who have not yet received a BTK inhibitor.

“Thanks to the impact of contemporary CLL treatments, many patients may receive fewer lines of therapy over their lifetime, making treatment choices in earlier lines profoundly important.

“This CHMP opinion represents a step toward an important global approval for Jaypirca in this indication and reflects our ambition to make Jaypirca available to every CLL patient who may benefit, at any line of therapy.”

Lilly has also submitted data from these studies to the US Food and Drug Administration (FDA), with a decision expected in the second half of 2026.

BRUIN CLL-313 is a global, open-label, Phase III study that involved 282 patients with CLL or small lymphocytic lymphoma without 17p deletions, randomised to receive either pirtobrutinib or chemoimmunotherapy.

BRUIN CLL-314 is a randomised, open-label, Phase III study assessing Jaypirca against Imbruvica (ibrutinib) in 662 patients who were treatment-naïve or BTK inhibitor-naïve. Both trials included various efficacy and safety measures as endpoints.

Jaypirca is a highly selective, non-covalent c inhibitor approved by the US FDA as an oral prescription medicine for various B-cell malignancies. It is administered as a once-daily 200mg dose.

CLL is a slow-growing form of non-Hodgkin lymphoma from lymphocytes and remains one of the most common forms of adult leukaemia.

Lilly recently signed a research and collaboration agreement with Swedish biopharmaceutical company BioArctic to develop a potential treatment for neurodegenerative diseases.

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Strides Pharma Science has announced a strategic investment in its wholly owned subsidiary, Pivot Path, by a consortium led by Ascent Capital, along with co-investor Vintage Classic. The transaction values Pivot Path at approximately ₹2.3 billion on a post-money basis and is aimed at accelerating the company’s next phase of growth.

Under the transaction, Strides will realise around ₹1 billion while retaining an approximately 20 per cent ownership stake in Pivot Path. The deal also includes a primary capital infusion of ₹500 million to support the company’s expansion strategy and technology investments.

According to Strides, the transaction aligns with its strategy of creating, scaling and unlocking value from high-potential businesses while continuing to participate in their future growth. The proceeds will also strengthen the company’s balance sheet while providing growth capital for Pivot Path.

Pivot Path originated within Arco Lab, Strides’ Global Capability Centre (GCC), where it developed expertise across life sciences consulting, digital transformation, quality and compliance, and technology-enabled operational services. As demand from external pharmaceutical and life sciences companies increased, the business evolved into an independent platform serving leading industry customers.

To support its next phase of growth, strengthen its ability to serve global customers, build agentic AI platforms and access external capital, the business was carved out into Pivot Path through a Scheme of Arrangement approved by the National Company Law Tribunal (NCLT) in May 2026. Following completion of the transaction, Pivot Path will be reclassified as an associate of Strides.

The transaction was undertaken based on an independent valuation conducted by a SEBI-registered merchant banker, reflecting Pivot Path’s differentiated capabilities, established customer relationships and long-term growth potential.

For FY26, the carved-out business reported revenue of ₹1,447 million, including revenue from services rendered to Strides, and EBITDA of ₹169 million, highlighting its profitable operating platform and growth trajectory.

Commenting on the transaction, Badree Komandur, MD & Group CEO, Strides, said, “Pivot Path exemplifies Strides’ proven capability to identify, incubate and scale high-potential businesses. Over the past years, we have built a platform with specialised capabilities, a growing customer base and a strong foundation for future growth.As the business enters its next phase, we believe this is the right time to bring in a strategic investment partner with the expertise and capital to accelerate its growth. This transaction unlocks value for Strides, provides Pivot Path with the resources to scale independently, and allows Strides to retain meaningful participation in its future success. We are delighted to partner with Ascent Capital and its investor consortium, whose experience in building high-growth businesses will support Pivot Path’s long-term ambitions.”

Raja Kumar, MD & Founder, Ascent Capital, said, “Pivot Path brings deep domain expertise across the core, non-discretionary segments of the pharmaceutical industry, capabilities that have been rigorously honed within the Strides stable. As an Independent entity, Pivot Path is exceptionally well positioned to combine the power of technology and Agentic-AI with its 400+ subject matter experts in building purpose-built solutions that enable global customers to manage their compliance, digital transformation, and drug safety requirements with greater speed, precision, cost effectiveness and confidence. We are excited to partner with Pivot Path’s accomplished management team as the company enters its next phase of growth in one of the most dynamic environments the industry has seen.”

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Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapsone Gel, 5%.

Dapsone Gel is indicated for the topical treatment of acne vulgaris.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Aczone Gel, 5%, of Almirall, LLC.

Alembic has a cumulative total of 244 ANDA approvals (224 final approvals and 20 tentative approvals) from USFDA.

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The collaboration will see the two companies gather and analyse data from a large number of patient samples across cancer and autoimmune diseases.

Immunai’s single-cell AI platform will be used in detecting T-cell dysfunction patterns.

Confirmed findings will then move to Immunai’s laboratory facilities, where they could serve as foundations for new portfolio projects within Boehringer Ingelheim’s drug discovery operations.

T-cell dysfunction has a major role in the development of both cancer and autoimmune conditions, though research on these two disease areas has typically been separated.

The collaboration aims to bridge this by using single-cell multiomic data and AI-driven functional validation to reveal biological mechanisms and targets that might not appear via more conventional or isolated research approaches.

Immunai’s AMICA-OS AI operating system combines harmonised immune-focused single-cell data with AI framework models and laboratory target validation processes to yield insights suitable for drug discovery.

Boehringer Ingelheim discovery research global head Lamine Mbow said: “Across oncology and inflammatory / autoimmune diseases, patients continue to face serious unmet medical needs, and too many still lack treatment options that can meaningfully change the course of disease.

“At Boehringer Ingelheim, we are committed to identifying and developing new treatment approaches and novel modalities in areas where patients need more. This collaboration reflects our ambition to pursue innovative science and translate new biological insights into potential medicines that can improve patient outcomes.”

Immunai has announced other collaborations in the sector, including agreements with Bristol Myers Squibb and AstraZeneca in 2026, focused on applying its technology platform to oncology and immune data analysis.

Recently, Boehringer Ingelheim signed a research collaboration agreement with Combotope Therapeutics to advance tumour-selective antibody therapies targeting cancer.

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Under the agreement, Recordati will handle regulatory filings and oversee commercial operations outside the US, including supporting early access initiatives in line with local regulations.

Ionis will receive a $30m upfront payment as part of the deal and stands to gain further milestone payments and tiered royalties of up to the mid-20% range on annual net sales.

The investigational medicine, zilganersen, is under review by the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for 22 September.

Ionis CEO Brett Monia said: “Recordati combines proven rare disease and global commercialisation expertise with deep experience navigating regional and local regulatory environments and the infrastructure needed to reach patients outside the US, making them the right partner to deliver zilganersen to patients with urgency. They recognise, as we do, the high unmet need for this rare, serious and often fatal neurodegenerative disease.”

Recent clinical data announced by Ionis indicated that zilganersen achieved the primary endpoint in patients aged five years and above in a pivotal study.

Zilganersen was generally well tolerated in the study, with most adverse events reported as mild or moderate, and fewer serious treatment-emergent adverse events observed in active treatment groups compared to pooled controls.

The medicine has received breakthrough therapy, orphan drug, and rare paediatric disease designations from the FDA, as well as an orphan drug designation from the European Medicines Agency.

In September 2025, Ionis Pharmaceuticals and Sobi announced the approval of Tryngolza (olezarsen) in the EU for adults with familial chylomicronemia syndrome.

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Zydus Lifesciences and Sunshine Healthcare announced the setting up of a strategic joint venture company – Zydus Sunshine Lifesciences Pvt Ltd., with an investment commitment of over $20 million to establish a pharma manufacturing facility in Sri Lanka.

The facility, to be located at the Board of Investment zone in Horana, will be developed on nearly four acres of land. The foundation stone was laid today, marking the formal commencement of the project. The plant will focus on manufacturing pharmaceutical products for Sri Lanka’s retail market, improving access to high-quality medicines while supporting national supply chain resilience, informed the company.

A press statement also informed that the partnership will support technology transfer, build local manufacturing capability, and create employment, contributing to the long-term development of Sri Lanka’s healthcare ecosystem.

The project will operate under the oversight of the Board of Investment, with the Ministry of Health and the National Medicines Regulatory Authority as key stakeholders. All products will comply with NMRA regulations and applicable pricing frameworks.

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The Ministry of Health and Family Welfare has notified the Drugs (Seventh Amendment) Rules, 2026, introducing significant changes to the Drugs Rules, 1945 by expanding Schedule H2 to cover additional therapeutic categories of medicines.

Issued on June 22, 2026, the amendment follows the publication of draft rules in October 2025 and the consideration of stakeholder feedback after consultation with the Drugs Technical Advisory Board (DTAB).

Under the amendment, the existing table in Schedule H2 will be redesignated as Table 1, and a new Table 2 will be inserted. The new table includes four therapeutic categories of drug formulations:

• All vaccines
• All antimicrobials
• All narcotic drugs and psychotropic substances covered under the Narcotic Drugs and Psychotropic Substances Act, 1985, and the rules made thereunder
• All anticancer drugs

The Drugs (Seventh Amendment) Rules, 2026 will come into effect from July 1, 2027.

However, Serial Number 2 (All Antimicrobials) in Table 2 will come into force a year later, on July 1, 2028.

According to the notification, the amendments were introduced after the government invited public comments on the draft rules published on October 16, 2025, with the consultation process concluding after stakeholders’ suggestions were examined.

The amendments have been made in exercise of the powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.

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Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Oseltamivir Phosphate for Oral Suspension, 6 mg/mL.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tamiflu Oral Suspension, 6 mg/mL, of Hoffmann-La Roche. Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI) indicated for:

i) treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours, and

ii) Prophylaxis of influenza A and B in patients 1 year and older.

Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, have an estimated market size of $ 27 million for twelve months ending March 2026 according to IQVIA.

Alembic has a cumulative total of 243 ANDA approvals (223 final approvals and 20 tentative approvals) from USFDA.

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The National Pharmaceutical Pricing Authority (NPPA) has integrated the Pharma Jan Samadhan portal with the Pharma Sahi Daam portal. The move aims to provide citizens with a single digital platform for medicine price verification and grievance redressal.

The unified platform enables users to check the prices of scheduled and non-scheduled medicines and lodge complaints related to medicine pricing through a single web portal and mobile application. While both services were already available through the mobile app, they previously operated via separate web portals.

According to the Department of Pharmaceuticals, the integrated platform is operational with immediate effect and is aimed at enhancing transparency, accountability, public participation, and access to affordable medicines.

Source: PIB

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Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mg.

The US FDA has tentatively approved Lupin’s Enzalutamide Tablets, 40 mg and 80 mg as bioequivalent to reference listed drug (RLD) Xtandi Tablets of Astellas for the indication in the approved labeling.

While Xtandi Tablets are traditionally available in 40 mg and 80 mg strengths, Lupin’s tentatively approved 120 mg and 160 mg strengths will provide healthcare providers and patients with alternative dosing options, informed the company.

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Indoco Remedies has announced that the Malta Medicines Authority had inspected the Company’s manufacturing facility for solid oral dosage form (Plant I) located at Goa, from November 19 – November 24, 2025.

The facility has received EU GMP certification from the Malta Medicines Authority confirming that it complies with the Good Manufacturing Practice requirements as referred in the EC Directive.

Commenting on this development, Aditi Panandikar, MD, Indoco Remedies said, “Compliance is a core value that drives our quality systems. This approval reinforces our commitment to delivering highest quality healthcare to our customers worldwide.”

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Shilpa Biologicals, a subsidiary of Shilpa Medicare, announced the commissioning of a state-of-the-art Antibody–Drug Conjugate (ADC) GMP manufacturing facility in Dharwad, Karnataka. The company informed that the facility which is fully operational, is designed to meet global regulatory approval standards including US FDA, EMA, and other major health authority requirements.

Sridevi Khambhampaty, CEO, Shilpa Biologicals commented, “The manufacturing of highly potent compounds has been a core pillar of Shilpa’s identity and this ADC drug substance facility adds a new sophisticated dimension to the capabilities of the Shilpa group, we now offer global biotech and pharma partners a uniquely integrated ADC facility built with the knowledge of our existing high potency manufacturing excellence.”

In a press statement, the company informed, “With this commissioning, Shilpa Medicare becomes one of the very few companies in India to offer fully integrated, end-to-end ADC drug substance development and manufacturing — encompassing payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation, and purification of GMP-scale drug substance. The manufacture of ADC drug substance demands specialised cytotoxic payload containment, precise conjugation chemistry, and rigorous biologic purification — all within a GMP-validated environment. This positions Shilpa as a compelling, cost-competitive CDMO partner for global pharma and biotech companies seeking high-quality, integrated ADC drug substance solutions.”

“India has the scientific talent and now, with this facility, the infrastructure to be a serious and trusted partner in global ADC drug substance manufacturing. Our 25-year foundation in high potency manufacturing gives us a head start that very few can match. We are ready to partner with the world’s leading oncology innovators,” said Vishnukant Bhutada, MD, Shilpa Medicare.

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LifeArc Ventures, Oxford Science Enterprises and the University of Oxford also participated in the round.

The company’s lead asset, RQB01, is currently in investigational new drug (IND)-enabling studies.

It is designed with a dual mechanism of action that targets conserved influenza epitopes, aiming to provide broad protection against various strains that are less affected by seasonal variations.

The company stated that the product’s combination of extensive strain coverage, high neutralising activity and an extended duration of effect may offer a different approach to influenza prophylaxis specifically for vulnerable populations.

RQ Bio CEO Mike Westby said: “Influenza remains a serious and persistent threat for patients whose immune systems cannot rely on vaccination alone. Our vision is to develop a preventative therapy capable of delivering reliable protection for an entire flu season with a single administration.

“This financing will support clinical development of RQB01 as well as advance our proprietary antibody discovery approach towards a pipeline of assets for prophylaxis of respiratory viral diseases.”

Frazier Life Sciences partner and RQ Bio Board of Directors member Joe Cabral said: “We believe RQB01 possesses several differentiated attributes that will translate to efficacious, season-long prevention of flu in an attractive product format.”

In addition to the funding, RQ Bio announced the appointment of Christian Schade as executive chairman.

Schade previously served as president and CEO of Halda Therapeutics, which was acquired by Johnson & Johnson in December 2025 for $3.05bn.

RQ Bio reported that Schade will contribute his industry experience to guide its corporate strategy and growth.

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It makes the combination the first regimen that pairs a programmed death-1 (PD-1) inhibitor and an antibody-drug conjugate to be available to this patient group across all 27 EU countries, as well as in Iceland, Liechtenstein and Norway.

The approval is based on results from the Phase III KEYNOTE-905/EV-303 trial, conducted in partnership with Pfizer and Astellas.

The trial found that patients receiving the combination had statistically significant and clinically meaningful improvements in event-free survival (EFS), overall survival, and pathologic complete response rates compared to those who underwent surgery alone.

Data showed that the combination reduced the risk of EFS events by 60%, with median EFS not reached for the combination versus 15.7 months for surgery alone.

Additionally, the risk of death was reduced by 50% with the combination therapy. The pathologic complete response rate was 57.1% with Keytruda plus Padcev compared to 8.6% for surgery alone.

MSD Research Laboratories senior vice-president and oncology, global clinical development head Dr Marjorie Green said: “For patients with resectable muscle-invasive bladder cancer in Europe, this approval represents a meaningful advance after years of limited progress in the field.

“As the first PD-1 inhibitor plus antibody-drug conjugate regimen approved in this setting, this treatment is poised to address a crucial unmet need, reflecting our continued commitment to delivering innovative Keytruda-based therapies to patients with bladder cancer worldwide.”

The decision follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use made in May 2026.

Commercial availability in each EU country will depend on the completion of national reimbursement processes.

Both Keytruda and Padcev were previously approved for a similar indication in the US in November 2025.

The ongoing KEYNOTE-905/EV-303 trial enrolled 595 patients and is evaluating several combinations and sequences of perioperative treatments compared with surgery alone.

Earlier this month, MSD received approval from the US Food and Drug Administration (FDA) for both Keytruda and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Welireg (belzutifan), as adjuvant treatment for adults with renal cell carcinoma with a clear cell component (ccRCC).

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Eli Lilly and Company India announced the launch of Tanstrive (selpercatinib) in India, following marketing authorisation from the Central Drugs Standard Control Organization (CDSCO) for patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene. Tanstrive (selpercatinib) is designed to selectively target RET alterations and block the abnormal signalling pathways that drive tumour growth. As an oral therapy administered twice daily, Tanstrive (selpercatinib) offers a targeted treatment approach for eligible patients whose cancers are driven by RET alterations. By targeting the underlying molecular drivers of disease, Tanstrive (selpercatinib) supports precision treatment based on biomarker identification and has demonstrated rapid and durable responses, including meaningful activity in patients with central nervous system (CNS) involvement.¹

Tanstrive (selpercatinib) is a prescription medicine used to treat certain cancers caused by abnormal RET genes in:

• Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion.
• Adult and pediatric patients two years of age and older with advanced or metastatic medullary thyroid cancer (MTC)with a RET mutation, who require systemic therapy.
• Adult and pediatric patients two years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
• Adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Winselow Tucker, President and General Manager, Eli Lilly and Company (India) said, “The launch of Tanstrive (selpercatinib) in India reflects our commitment to bringing innovative, evidence-based therapies to patients with RET-altered cancers, including those with limited treatment options across tumour types. As precision oncology continues to reshape cancer care, Tanstrive represents an important step forward, expanding access to targeted therapies for patients in India.”

Dr Rahul Kapur, Senior Director, Medical, Eli Lilly and Company (India) said, “As the first and only selective RET inhibitor approved in India for RET-altered solid tumours regardless of tumour type, Tanstrive (selpercatinib) is designed to target the molecular drivers of these cancers directly — offering a precision, biomarker-guided option with demonstrated rapid and durable responses, including activity in patients with central nervous system involvement. This underscores the importance of routine, comprehensive genomic testing for patients across a wide variety of tumour types.”

RET alterations are rare but clinically actionable genetic drivers that can promote tumour growth across multiple cancer types, including NSCLC, thyroid cancers and certain solid tumours. RET gene fusions are found in approximately 1–2 per cent of patients with NSCLC in India, representing a small but important subset of patients who may benefit from biomarker-guided treatment approaches. RET alterations are observed in less than one per cent of all tumour types overall but are particularly relevant in thyroid cancers, including approximately 50 per cent of medullary thyroid cancers and 10–20 per cent of papillary thyroid cancers.

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India’s hair restoration industry has witnessed significant growth over the last decade. What are the key factors driving this expansion, and how do you see the market evolving over the next five years?

India’s hair restoration market has grown because of rising hair-loss prevalence.

Higher disposable incomes, Hair transplantation, once viewed as a luxury service, has become accessible due to Increased affordability and financing and EMI options.

Improved technologies like DHT (direct hair transplantation) where out of body time of graft lesser max up to 30 minutes and success rate is almost 100 per cent.

Greater social acceptance of cosmetic procedures, public attitudes toward cosmetic treatments have changed significantly. Influences include:, Celebrity openness about appearance enhancement. Social media-driven emphasis on personal image.

Lower procedure costs compared with North America, Europe, and parts of the Middle East. Availability of experienced surgeons. Strong private healthcare infrastructure. Over the next five years, the sector is likely to become more organised, technology-driven, and geographically diverse.

Hair loss management today encompasses pharmaceuticals, cosmeceuticals, nutraceuticals, and surgical interventions. How can stakeholders across these segments collaborate to create a more integrated hair health ecosystem?

Hair loss is multifactorial and progressive, so no single segment holds the complete answer. Most patients move along a continuum: medical management to slow and reverse miniaturisation, regenerative and nutritional support to strengthen existing hair, and surgery only when it is genuinely indicated. At Eugenix we call this Complete Hair Restoration, because a transplant protects nothing if the surrounding native hair is left untreated.

The real barrier to an integrated ecosystem is fragmentation. Each segment tends to market in isolation, sometimes with inflated promises, which leaves patients confused and distrustful. The way forward is to organise around the patient rather than the product. That means shared, evidence-based standards on what each product or service can and cannot do, honest patient education that counters misinformation, and open referral pathways between dermatologists, trichologists, surgeons, and nutrition specialists. When we published our work on DHT, we deliberately chose not to patent the technique, so the wider community could adopt and build on it. That same spirit of shared knowledge, rather than siloed competition, is what an integrated hair health ecosystem will require.

From an innovation standpoint, which ingredients, formulations, or therapeutic approaches are showing the greatest potential in hair growth and scalp health, and where do you see the most active R&D efforts globally?

For nearly three decades the medical toolkit barely changed. Topical minoxidil and oral finasteride were essentially the whole story. That is finally shifting, and it is the most exciting phase the field has seen.

The most promising direction is targeted, follicle-level action with fewer systemic effects. Topical anti-androgens that block DHT at the receptor within the scalp are the most advanced of the new candidates, and reformulations such as extended-release oral minoxidil aim to keep efficacy while reducing cardiovascular concerns. In parallel, regenerative biology is maturing: growth factor concentrates, exosomes, and approaches that reactivate dormant follicle stem cells. These are genuinely promising, but much of this work is still at the investigation stage and there is more work to be done still on this. As clinicians we owe patients honesty about what is proven versus what is still emerging.

For autoimmune hair loss, JAK (Janus Kinase) inhibitors have been transformative, though that is a different condition from pattern baldness. Looking further ahead, scalp microbiome science and AI-assisted, genetically informed diagnosis are where I expect the next wave. The most active R&D today sits in the United States, Europe, South Korea, and Japan, and the clear consensus is that combination therapy, not any single molecule, will define real-world outcomes.

As demand for hair restoration rises, quality and standardization have become critical concerns. What regulatory frameworks or accreditation mechanisms would help strengthen credibility and patient safety across the industry?

Long-term growth and credibility of India’s hair restoration industry will depend on strong regulatory oversight, standardised clinical practices, and greater transparency. Clear qualification requirements, clinic accreditation, and ethical marketing standards can significantly enhance patient safety and treatment outcomes. At the same time, robust data collection and consumer education will help build trust and accountability across the sector. By balancing innovation with quality governance, the industry can achieve sustainable growth while delivering higher standards of care and patient confidence.

What role can Indian pharmaceutical and cosmeceutical companies play in advancing evidence-based hair care solutions and addressing unmet needs in hair loss management?

Indian pharmaceutical and cosmeceutical companies have a unique opportunity to transform hair loss management through science-driven innovation and evidence-based product development. By investing in clinical research, advancing novel therapies, and ensuring product efficacy and safety, they can address significant unmet patient needs. Greater collaboration with dermatologists, researchers, and healthcare institutions will further strengthen treatment standards and outcomes. At the same time, improving accessibility, affordability, and patient education can expand the reach of effective hair care solutions across the country. As the market evolves, a focus on personalized, research-backed approaches will be key to building consumer trust and driving sustainable growth in the hair care industry.

What business lessons can the broader aesthetics and dermatology industry learn from the rapid growth of the hair restoration segment?

The first lesson is that depth beats breadth. Hair restoration grew fastest where clinics went deep on a single problem and built genuine, measurable expertise, rather than offering it as one item on a long aesthetic menu. Focus earns trust, and trust compounds over time.

Second, the segment showed how to scale a highly skilled, almost artisanal procedure without diluting quality, through structured training, standard protocols, and systematic knowledge transfer. The craft has to become a repeatable system if it is to grow responsibly.

Third, and most important, growth was driven by visible, demonstrable outcomes and patient word of mouth, but the field also paid a price for over-marketing and fabricated results. The durable lesson for all of aesthetics and dermatology is that authenticity protects a category. At Eugenix as a policy, we choose not to use AI-generated result images for exactly this reason. Education, honesty, and managing expectations are not brakes on growth, they are what make it sustainable.

Finally, hair restoration is never one and done. It is a long relationship of maintenance and follow-up, a reminder that lifetime patient trust, backed by genuine accreditation and quality signals, matters far more than any single transaction.

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The Central Drugs Standard Control Organization (CDSCO) has issued a clarification on the regulatory framework for formulation intermediates such as directly compressible granules, taste-masked granules, and modified-release granules and pellets, aiming to bring uniformity in their licensing across the country.

The clarification follows representations received from industry seeking clarity on the regulatory requirements for formulation intermediates used in direct compression and capsule filling. The matter was discussed internally and deliberated at the 68th meeting of the Drugs Consultative Committee (DCC) held on March 20, 2026.

According to the circular, formulation intermediates intended for use in modified-release dosage forms, including sustained release (SR), extended release (ER), prolonged release (PR), and delayed release (DR) formulations, will require prior approval from CDSCO under the New Drugs and Clinical Trials (NDCT) Rules, 2019.

The regulator stated that modified or sustained-release dosage forms are deemed to be new drugs under Rule 2(1)(w) of the NDCT Rules, 2019. Consequently, bulk SR, ER, PR and DR pellets and granules used in such formulations will also require CDSCO approval. Manufacturers must submit applications for both the pharmaceutical formulation and the corresponding formulation intermediate to CDSCO for permission to manufacture for sale or distribution.

For formulation intermediates that are not classified as new drugs, such as directly compressible granules, manufacturers can apply to the respective State Licensing Authority (SLA) for manufacturing licences. However, if such formulation intermediates contain any new or novel excipient, approval from CDSCO will be mandatory.

The circular also states that applications for formulation intermediates should be submitted either to CDSCO or the relevant State Licensing Authority, depending on the applicable regulatory pathway for import, manufacturing and marketing.

The clarification is expected to provide greater regulatory certainty for manufacturers of formulation intermediates while ensuring a uniform licensing approach across states.

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Concord Biotech has announced the successful completion of a joint inspection of its Unit-II formulation facility by the Pharmacy and Poisons Board (PPB), Kenya, and the National Drug Authority (NDA), Uganda.

The inspection was conducted from June 18 to June 24, 2026, and concluded successfully, the company said in a regulatory filing.

The company said the outcome reinforces its commitment to maintaining high standards of quality and regulatory compliance while strengthening its global manufacturing and regulatory footprint.

The company disclosed the development in a filing with the stock exchanges for information and record.

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Combotope CEO Ola Blixt said: “At Combotope, we focus on cancer-specific glycan–protein targets that conventional antibody approaches cannot selectively address.

“By combining glycan and protein recognition, we aim to enable a new class of tumour-selective antibodies and expand the range of viable targets in oncology.

“We are excited to partner with Boehringer Ingelheim to translate this approach into potentially differentiated therapies.”

Initially, the agreement covers multiple oncology targets named by Boehringer Ingelheim, with the possibility of including additional targets in the future.

For each nominated target, Combotope will deploy its platform to generate antibodies, accompanied by a specific antibody characterisation data package.

Boehringer Ingelheim will then progress the research, as well as take responsibility for the development, manufacturing and commercialisation of any therapies resulting from the collaboration.

Combotope will be eligible for an upfront payment and additional research funding linked to each target.

The company could also receive development, regulatory and commercial milestone payments, along with royalties on net sales from any commercialised product.

Boehringer Ingelheim will hold worldwide development and commercialisation rights to therapies originating from the agreement. Specific financial details have not been disclosed.

In April 2026, Boehringer Ingelheim and Zai Lab entered a clinical collaboration to investigate a dual delta-like ligand 3 (DLL3)-targeting approach for patients with extensive-stage small cell lung cancer (ES-SCLC) and other neuroendocrine carcinomas (NECs).

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Apexon, an AI-first technology services company specialising in engineering intelligent enterprises and an AWS Advanced Tier Services Partner with Life Sciences and Migration Competencies, has announced that it has signed a strategic collaboration agreement (SCA) with Amazon Web Services, Inc. (AWS). Under the agreement, the companies plan to deliver agentic AI deployment, cloud-native modernisation and full-stack digital engineering solutions built on AWS for healthcare and life sciences organisations.

According to the company, the collaboration builds on more than 100 AWS engagements and combines Apexon’s AgentRise Agentic AI platform, forward-deployed engineering model and proprietary accelerators including CloudAlpha, PlatformAlpha and TransformAlpha for cloud migration and modernisation, along with Genysys for AI deployment on AWS. These capabilities will be integrated with AWS services including Amazon HealthLake, Amazon Bedrock and Amazon SageMaker to support the deployment of production-grade AI agents into clinical, commercial and operational workflows. The delivery model places engineering, AI deployment and infrastructure operations under a single accountable team operating within the customer’s environment.

The company stated that, for healthcare and life sciences organisations, the collaboration is intended to support the operationalisation of production-grade AI agents across clinical, commercial and operational functions, accelerate the migration of legacy workloads to a cloud foundation and provide a delivery model where engineering, AI deployment and infrastructure operations are managed by one accountable team. According to the company, leading biopharma organisations have validated that these capabilities can deliver productivity improvements of 30 to 50 per cent across regulated workflows.

Under the agreement, Apexon and AWS will jointly develop and deploy domain-specific agentic AI solutions for healthcare and life sciences organisations across six areas. These include research and development to support drug discovery and compound analysis through AI-driven research workflows; clinical trials to optimise trial operations and reduce clinical document drafting time by up to 50 per cent; commercial and medical affairs to support field teams with AI-driven intelligence; manufacturing and supply chain to enable self-healing manufacturing processes through real-time agentic monitoring and response; enterprise IT to automate regulatory document workflows and modernise enterprise systems on AWS; and healthcare modernisation to rebuild legacy healthcare infrastructure on a cloud-native, AI-ready foundation.

According to the company, these 20 use cases are intended to address industry challenges where legacy approaches have fallen short. The company added that leading biopharma organisations have validated that Apexon’s domain-specific agentic AI solutions can deliver productivity improvements of 30 to 50 per cent, while supporting innovation cycles and business agility across regulated industries.

Justin Marcucci, President, Apexon, said, “While enterprises have largely begun to solve for AI strategy, the overwhelming gap that remains is scaled AI delivery: getting from a compelling use case to a system that runs in production, integrates with live data, adapts to the realities of the business, and compounds in value over time. In Healthcare and Life Sciences, that gap has real consequences for drug discovery timelines, clinical operations, and patient outcomes. This strategic collaboration agreement with AWS gives us the infrastructure depth and the service ecosystem to close that gap for our clients, at a scale that changes what is possible for them.”

The company stated that the strategic collaboration agreement builds on Apexon’s AWS competency recognitions in Data and Analytics, Migration, Life Sciences and DevOps. According to the company, the agreement combines engineering capabilities, domain expertise and agentic AI to support healthcare and life sciences organisations in modernising operations and delivering business outcomes.

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Haisco will receive $40m in upfront and near-term payments, with the potential for additional development, regulatory and commercial milestone payments totalling as much as $1.4bn.

The company is also eligible for tiered royalties on net sales of any resulting products. The first four milestone payments may be made by Nuvectis in a mix of cash and common stock, with the equity component capped at under 40% of the milestone value.

If Nuvectis sublicenses its rights or undergoes a change of control during a restricted period, Haisco will be entitled to appropriate sublicence income and related payments.

The agreement is subject to financing conditions intended to ensure Nuvectis can support development activities.

HSK42360, a B-raf proto-oncogene, serine/threonine kinase (BRAF) paradoxical breaker inhibitor designed to address resistance to current BRAF inhibitors, is under evaluation in a Phase I clinical trial in China.

Another drug candidate, HSK39297, a potential once-daily complement factor B (CFB) inhibitor, has two new drug applications (NDAs) submitted in China for paroxysmal nocturnal haemoglobinuria (PNH), and further clinical development for additional indications is ongoing.

Haisco CEO Dr Pangke Yan said: “This collaboration is highly aligned with our global development strategy and is expected to generate sustainable value and long-term returns.

“By partnering with a US biotechnology company such as Nuvectis, Haisco aims to accelerate the global development of innovative oncology and complement therapies and bring high-quality treatment options to patients worldwide.”

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Dr. Reddy’s Laboratories has released a whitepaper titled “Translational Research Ecosystem: Learnings from the World & Building for India”, highlighting the role of translational science in connecting scientific discovery with healthcare delivery. The report examines translational science at the intersection of scientific innovation, multidisciplinary collaboration, funding, regulation, clinical development, policymaking and commercialisation.

The whitepaper brings together recommendations and insights from experts representing academia, industry, government, not-for-profit organisations and hospitals in India and globally. It is based on discussions held during the third roundtable convened by Dr. Reddy’s as a prelude to the Dr. Anji Reddy Memorial Lecture Series.

According to the company, translational science helps bridge the gap between scientific discovery and practical application by supporting the movement of research from laboratories to patient care. The whitepaper states that scientific, operational, financial and regulatory challenges continue to influence the pace and scale of this process.

The report outlines barriers in translational research and identifies opportunities for India to strengthen systems that support the conversion of scientific discoveries into therapies, technologies and healthcare solutions. It notes that while India has established many of the elements required for innovation, challenges including regulatory approvals, funding gaps and the need for stronger collaboration between academia and industry continue to affect progress. Drawing on global learnings, the whitepaper presents an evidence-based framework to address these gaps and states that collaboration across academia, industry, healthcare institutions, funding bodies and government will be required to accelerate the translation of research into patient benefit.

Satish Reddy, Chairman, Dr. Reddy’s, said; “India stands at a critical inflection point in its innovation journey. To realize our ambition of becoming a global discovery hub, we need a step change, from incremental progress to innovation at scale. This requires stronger translational research pathways to ensure that scientific discoveries translate into meaningful patient impact, alongside accelerated R&D, scaled talent aligned to academic and research structures, and shared infrastructure to support innovation more efficiently. With the right coordination, India has the potential to play an important role in shaping the future of healthcare.”

The whitepaper identifies bridging the translational gap as one of the priorities for India’s research ecosystem. It states that although India has developed capabilities in scientific research and pharmaceutical manufacturing, the pathway between early-stage discovery and clinical development remains fragmented, resulting in innovations losing momentum before reaching patients.

The report also calls for greater collaboration between academia, industry, healthcare institutions, investors and government agencies to support the translation of scientific research into healthcare solutions. It states that sustained and structured funding mechanisms are required to support innovations through the stages of discovery, development and commercialisation.

Another recommendation is the development of regulatory capability through structured programmes or a centre of excellence for innovation. According to the report, regulatory systems need to evolve alongside scientific advances to support researchers, developers and investors.

The whitepaper also highlights the role of India’s hospitals, patient cohorts and real-world clinical data as research assets that can support innovation when integrated into translational pathways. It further states that progress should be measured by the number of innovations reaching patients and improving health outcomes rather than research outputs alone.

The third roundtable featured Dr. Soumya Swaminathan, Chairperson, M S Swaminathan Research Foundation; Prof. V. Ramgopal Rao, Vice Chancellor, BITS Pilani; Dr. Shivkumar Kalyanaraman, CEO, ANRF; Prof. Guido Kroemer, Université Paris Cité and Gustave Roussy Cancer Campus, Paris; Dr. Satya Prakash Dash, CEO, IKP Knowledge Park, Hyderabad; Dr. Murali Ramachandra, CEO, Aurigene Oncology Ltd., Bengaluru; Prof. B.J. Rao, Former Vice-Chancellor, University of Hyderabad; and Dr. Hrishikesh Sarkar, Director, Center for Minimally Invasive Neurosurgery and Neuro-oncology, Continental Hospitals, Hyderabad. The roundtable was chaired by Satish Reddy, Chairman, Dr. Reddy’s.

Dr. Reddy’s instituted the Dr. Anji Reddy Memorial Lecture Series in 2023 to honour the contributions of scientist, entrepreneur and institution builder Dr. K. Anji Reddy, who founded Dr. Reddy’s Laboratories in 1984. The lecture series is based on the theme of Science, Society and Sustainability. Since 2024, the company has organised an annual roundtable before the lecture, bringing together Nobel Laureates and leaders from academia, research, science, industry, clinical practice and public institutions. Each roundtable concludes with a whitepaper developed in partnership with Citeline. Previous editions focused on “Emerging Frameworks in Innovation” and “Prevention, Cure & Quality of Life: A Multi-Stakeholder Perspective on Public Health”.

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 BDR Pharmaceuticals International has announced the launch of XATRONEM-AV (Aztreonam + Avibactam Injection) 2 g for the treatment of serious infections caused by multidrug-resistant (MDR) Gram-negative bacteria.

According to the company, the launch comes as antimicrobial resistance (AMR) continues to pose a healthcare challenge globally. Drug-resistant infections are estimated to directly cause nearly 1.9 million deaths annually and are associated with more than 8.2 million deaths worldwide every year. A study published in The Lancet estimates that AMR could account for nearly 39 million deaths between 2025 and 2050, while resulting in an annual economic burden of approximately US$1 trillion through healthcare expenditure and productivity losses.

The therapy is intended for use in hospitalised patients with severe infections, including complicated intra-abdominal infections, hospital-acquired infections, bloodstream infections, ventilator-associated infections and other serious Gram-negative bacterial infections where conventional therapies may prove ineffective.

According to BDR Pharma, the launch of XATRONEM-AV builds on its portfolio, which includes brands such as Xavitaz, Zisavel and Dalbonova, along with first generic introductions in India including Caspofungin, Anidulafungin and Biapenem. The company stated that it continues to focus on expanding access to therapies for critically ill patients across the country.

XATRONEM-AV is available as a 2 g injectable formulation. According to the company, the therapy expands access to antimicrobial treatment options for patients with life-threatening infections and supports the treatment of multidrug-resistant Gram-negative infections.

The company stated that the increasing burden of antimicrobial resistance has added to the complexity and cost of patient care worldwide. Infections caused by carbapenem-resistant and multidrug-resistant Gram-negative organisms are associated with prolonged hospital stays, increased healthcare expenditure, higher mortality rates and limited treatment options. According to the company, expanding access to treatment options can support timely and targeted treatment decisions.

Commenting on the launch, Dharmesh Shah, Chairman, BDR Pharma, said, “Antimicrobial resistance is one of the most pressing healthcare challenges of our time, placing a significant burden on patients and healthcare systems worldwide. With the launch of XATRONEM-AV, we aim to equip healthcare professionals with an important treatment option against multidrug-resistant Gram-negative infections, while reinforcing BDR Pharma’s commitment to delivering innovative and accessible therapies to patients who need them most.”

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Genprex’s Reqorsa is currently in development alongside approved cancer drugs.

Genprex is conducting the Acclaim-3 Phase I/II clinical trial to assess the combination of Reqorsa and Genentech’s Tecentriq (atezolizumab).

The trial is focused on patients with extensive-stage SCLC who have completed first-line therapy with Tecentriq and chemotherapy.

According to the company, the Phase I portion found Reqorsa to be generally well tolerated.

In Phase II, nearly 50 patients are set for enrolment, with the primary goal of measuring the 18‑week progression‑free survival rate following the start of maintenance therapy with Reqorsa and Tecentriq.

An interim analysis will take place after 25 patients have completed 18 weeks of follow-up. The trial is supported by fast track and orphan drug designations from the US Food and Drug Administration (FDA).

Genprex’s broader pipeline also includes gene therapy candidates in oncology and diabetes, with delivery technology involving non-viral, lipid-based nanoparticles.

Genprex intellectual property and licensing senior vice-president Thomas Gallagher said: “Securing this patent strengthens Genprex’s intellectual property portfolio, providing crucial protection for the therapeutic combinations currently being evaluated in the Acclaim-3 clinical trial.

“This achievement reinforces our competitive advantage and supports our strategy to bring innovative cancer treatments to patients worldwide.”

In November 2024, Genprex entered an exclusive licensing agreement with the University of Michigan for Reqorsa.

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BioArctic is set to receive a $30m upfront payment. If the new product progresses successfully, the company could gain additional milestone payments of up to $770m.

It is also eligible for tiered mid-single-digit royalties on future global sales should the candidate achieve regulatory approval and reach the market.

The collaboration involves BioArctic creating a new drug candidate by linking its platform with Lilly’s molecule.

According to the terms, Lilly will be responsible for the subsequent global development and commercialisation of the new product and any related compounds.

BioArctic CEO Gunilla Osswald said: “I’m excited by today’s announcement and proud that a large pharmaceutical company sees potential in our proprietary BrainTransporter technology. Lilly shares our ambition to do more for patients with severe neurological disorders, and this collaboration is a testament to that.”

This agreement marks the fourth time BioArctic has partnered on projects involving its BrainTransporter platform. The company maintains rights to use this technology outside the scope of its four existing collaborations.

The platform can be applied to a range of therapeutic areas to deliver various biologics and modalities to the brain, indicating further potential partnership opportunities in the future.

It is built to help drugs cross the blood-brain barrier by targeting the transferrin receptor.

By facilitating active transport of medicines into the brain, the technology aims to improve distribution, efficacy, safety, and dosing of therapies.

Earlier this month, Lilly entered a licensing agreement worth up to $1.26bn with Hanmi Pharm to develop, manufacture and commercialise Hanmi’s biologic drug candidate, sonefpeglutide (a LAPS GLP-2 analogue), worldwide excluding Korea.

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Parexel has launched the Parexel Biotech Incubator, an initiative based at the company’s North Hills Innovation District global headquarters in Raleigh, to connect early-stage therapeutics companies with clinical and regulatory expertise. The incubator has been launched alongside a partnership with Cape Fear BioCapital, a Durham-based seed-stage venture capital firm, and forms part of Parexel’s efforts to support early-stage innovation in collaboration with the venture community.

The Parexel Biotech Incubator is intended to support emerging therapeutics companies while their development strategies are still being defined. Participating companies will have access to Parexel’s clinical and regulatory expertise, including guidance on development planning, regulatory strategy and clinical trial design. They will also have access to shared physical workspace alongside Parexel’s Raleigh-based team.

“Reaching innovators at the earliest stages of their development journey, before clinical programs are formally structured, is where we can have the greatest impact. That is exactly what this initiative is designed to do,” said Peyton Howell, Chief Executive Officer of Parexel. “The incubator reflects the evolution of our support for the biotech community, connecting seed-stage investment to clinical development expertise at the stage when it matters most. It builds on our broader commitment to investing in early-stage innovation alongside leading venture firms, and our inaugural partnership with Cape Fear BioCapital deepens our roots in one of the most dynamic life sciences ecosystems in the country.”

The incubator builds on Parexel’s strategy of investing in and supporting early-stage innovation through collaborations with venture capital firms. The company has established collaborative relationships with venture firms to advance the next generation of therapeutics companies.

According to the company, its partnership with Cape Fear BioCapital is intended to address the gap between seed-stage investment and clinical development expertise for early-stage therapeutics companies. Cape Fear BioCapital focuses on advancing companies from early discovery through investigational new drug (IND) readiness. The collaboration provides a connection between portfolio companies and Parexel’s clinical and regulatory expertise during the development stage.

“The Parexel Biotech Incubator represents the next stage in Parexel Biotech’s evolution and extends our long-standing commitment to the biotech community,” said Jim Anthony, Chief Commercial Officer and President, Parexel Biotech. “By bringing our clinical and regulatory expertise to emerging innovators earlier in their development journeys, we can help companies make smarter development decisions, build stronger plans and position promising programs for lasting progress.”

North Carolina ranks seventh in the United States for life sciences employment, with more than 103,000 workers across nearly 6,700 establishments statewide. The state is home to Research Triangle Park, along with research institutions including Duke University, the University of North Carolina at Chapel Hill and NC State University. Parexel stated that Cape Fear BioCapital’s links with these institutions support the regional research pipeline for therapeutics companies.

“North Carolina has the scientific substrate, talent, and entrepreneurial ambition to build on our strong base of therapeutics innovation,” said Dave Ousterout, General Partner at Cape Fear BioCapital. “Working together with Parexel, we are dedicated to supporting emerging companies and connecting them with development expertise at a stage when strategic guidance can make a meaningful difference. Our partnership reflects a shared commitment to strengthening the support and capital available to innovators across the state.”

Parexel established its Durham location in 2014, expanded its presence in North Carolina in 2019, and opened its global headquarters in Raleigh’s North Hills Innovation District in 2025. Parexel Biotech, launched in 2019, is the company’s business unit focused on supporting emerging biopharmaceutical companies through development milestones.

Innovcare Lifesciences operates across the Indian market, focusing on the marketing, distribution, and sale of pharmaceutical products, nutraceuticals, and cosmeceuticals.

The company reported operational revenue of Rs940m for the financial year ending March 2026, following revenue of Rs860m in FY24-FY25 and Rs809m in FY23-FY24.

Sun Pharma indicated that the planned acquisition is part of its efforts to expand and strengthen its product portfolio.

The company specified that the transaction is not a related-party arrangement, and neither its promoters nor entities in the promoter group have any shareholding or interest in Innovcare Lifesciences.

Sun Pharma also stated that no governmental or regulatory approvals are needed to complete this transaction.

Following the conclusion of the deal, Sun Pharma will acquire full ownership and control of Innovcare Lifesciences.

In April 2026, Sun Pharmaceutical Industries agreed to acquire Organon in a deal with an enterprise valuation of $11.75bn in cash, paying $14 per share for all outstanding shares.

Created through a spinoff from Merck & Co (MSD) in 2021, Organon distributes more than 70 products across women’s health and general medicines, including biosimilars, reaching 140 countries.

In March 2026, the US Food and Drug Administration accepted for review Sun Pharmaceutical’s supplemental biologics licence application (sBLA) submitted for Ilumya (tildrakizumab-asmn) to treat adults with active psoriatic arthritis.

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The approved indications include combining Sarclisa SC with pomalidomide and dexamethasone (Pd) or with carfilzomib for relapsed or refractory multiple myeloma (r/r MM).

It is also approved in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) in adults.

A regulatory submission for the CirCLIQ on-body injector (OBI), based on Enable Injections’ enFuse platform, remains under review.

If cleared, Sarclisa SC could be Japan’s first anti-cancer treatment to utilise an OBI, offering both manual injection and OBI administration for MM.

Sanofi oncology global head Olivier Nataf said: “Today’s approval of Sarclisa subcutaneous represents an important evolution in how we deliver care for multiple myeloma patients in Japan.

“This new formulation significantly eases treatment burden and enhances convenience for patients compared to intravenous administration — with the potential to become Japan’s first anti-cancer therapy to be administered via an on-body injector.”

Pivotal data comes from the IRAKLIA Phase III study, which showed a 71.1% objective response rate (ORR) for Sarclisa SC-Pd administered via OBI, compared with 70.5% with IV-Pd.

Sarclisa SC demonstrated a safety profile consistent with the established IV formulation, with fewer infusion-related reactions (1.5% with SC-Pd vs 25% with IV-Pd).

The most frequent grade ≥3 non-haematologic adverse events included pneumonia, Covid-19, and upper respiratory tract infection. The common grade ≥3 haematologic laboratory abnormalities were neutropenia, thrombocytopenia, and anaemia.

In Japan, Sarclisa IV is approved for five indications, including as part of four r/r MM regimens and for NDMM. Sarclisa SC has EU approval across all current Sarclisa IV indications and is under review in the US.

Earlier this month, Sanofi entered a multi-year agreement with France-based agentic AI company Owkin to co-develop next-generation AI-driven biopharma agents.

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Sun Pharmaceutical Industries has been included in the 2026 S&P Dow Jones Best-in-Class World Index, a benchmark that recognises companies demonstrating leadership in sustainability performance.

The Dow Jones Best-in-Class Indices methodology identifies companies that lead their industries in addressing sustainability issues and set benchmarks for corporate sustainability performance. Based on the S&P Global Broad Market Index, nearly 2,500 of the world’s largest companies were identified by S&P Global. Among them, around 317 companies worldwide qualified, including 25 from India, for inclusion in the 2026 DJBIC Index.

Kirti Ganorkar, Managing Director, Sun Pharmaceutical Industries said, “This recognition is a testament to our continued commitment to responsible business practices and sustainable growth. At Sun Pharma, sustainability is embedded in the way we think, operate, and create value. It guides our purpose, shapes our actions, and remains central to our long-term strategy. Together with our people, we will continue driving meaningful impact through responsible innovation, climate-conscious operations, strong governance, and inclusive growth, while building a more sustainable future for generations to come”.

Aurobindo Pharma USA, Inc. (Aurobindo USA), a wholly owned subsidiary of Aurobindo Pharma, has received approval from the U.S. Federal Trade Commission (FTC) to proceed with the acquisition of Lannett Company LLC (Lannett).

The transaction, valued at $250 million on a cash-free, debt-free basis and inclusive of normalised working capital, is expected to close before the end of June 2026.

Lannett, a Pennsylvania-based generic pharmaceutical company, specialises in the development and commercialisation of a diversified portfolio of complex, non-opioid controlled substances. According to the company, the acquisition will expand Aurobindo USA’s product offering in this segment while adding a U.S.-based manufacturing facility to its network.

Lannett’s manufacturing site in Seymour, Indiana, has the capacity to scale production to approximately 4 billion doses annually, strengthening Aurobindo USA’s domestic manufacturing footprint. The company stated that this capacity aligns with U.S. policy priorities aimed at improving supply chain resilience and increasing domestic pharmaceutical production.

The transaction is expected to be immediately accretive to Aurobindo Group’s earnings per share. The company said the acquisition is also expected to generate cost efficiencies, SG&A synergies and operational integration advantages. It will also enhance the company’s portfolio with a differentiated pipeline of complex generics and controlled substances, supporting long-term growth.

Swami S. Iyer, Chief Executive Officer of Aurobindo Pharma USA, said, “This acquisition represents a highly compelling strategic and financial opportunity for Aurobindo USA. It accelerates our revenue growth, strengthens our U.S.-based manufacturing capabilities, and enhances our position in complex, non-opioid controlled substances. We are confident it will deliver immediate earnings accretion while creating long-term value for our shareholders through operational synergies and pipeline expansion. We are pleased to welcome the Lannett team and look forward to leveraging our combined strengths to expand and ensure reliable access to critical medications for patients.”

Tim Crew, Lannett Company’s Chief Executive Officer, said, “We are delighted to be joining forces with Aurobindo. As one of the nation’s oldest generic pharmaceutical companies, Lannett has a proud history of helping patients access affordable medicines. Aurobindo’s market reach and resources will help make our portfolio of medicines even more affordable and accessible for patients everywhere. Our board and owners extend their sincere appreciation to the outstanding teams at both companies whose professionalism, commitment, and hard work have successfully brought us to this important moment. We look forward to building on all that has come before as we begin a bright and exciting next chapter.”

There is a moment in 2001 that belongs in every business school curriculum, though it rarely appears in one.

A pharmaceutical executive stands before an audience at a European Commission meeting in Brussels and makes an offer that the global pharmaceutical industry had declared economically impossible. His company would supply triple-drug antiretroviral therapy — the life-saving combination that was transforming AIDS from a death sentence into a manageable disease — for $350 per patient per year. Western pharmaceutical companies were charging $10,000 to $15,000 for the same treatment. Médecins Sans Frontières, among others, would publicly welcome the announcement as a turning point.

The man was Dr. Yusuf K. Hamied. The company was Cipla. And the offer would eventually help save millions of lives, reshape international intellectual property law, and quietly prove that the conventional wisdom separating profit from purpose was not wisdom at all.

Founded in Mumbai in 1935 by Dr. Khwaja Abdul Hamied — a PhD chemist who had trained in Berlin and returned to British India with a radical conviction that medicines were a right, not a luxury — Cipla has spent nearly nine decades doing what the pharmaceutical industry said couldn’t be done: manufacturing medicines of unimpeachable quality, pricing them for the world’s poorest patients, and building a globally competitive enterprise in the process.

Today, Cipla operates in over 60 countries, commands a dominant position in global respiratory generics, and supplies essential medicines across Africa, Asia, and North America. It is India’s third-largest pharmaceutical company by revenue, and arguably its most consequential.

The story of how it got there offers six lessons that apply well beyond pharmaceuticals.

Lesson one: Purpose is not a tagline. It’s a business model

Cipla’s founding principle — “None shall be denied access to life-saving medicines due to inability to pay” — could have been a slogan. Instead, it became an operating instruction.

When Dr. Hamied senior set up his laboratory in Mumbai against the headwinds of colonial pharmaceutical monopolies, he was making a commercial argument as much as a moral one. British and European companies dominated the Indian market with imported medicines priced for the wealthy. The vast majority of Indians went untreated not because medicines didn’t exist, but because no one was making them affordable. The gap between what patients could pay and what multinationals would charge was not a charity problem — it was a market opportunity for anyone willing to build a business around it.

This distinction matters enormously. Companies that treat purpose as a marketing overlay behave very differently from companies that treat purpose as a strategic constraint. Cipla’s founders accepted lower margins as a design feature. The company would make money through volume — by serving hundreds of millions rather than thousands — and it would compete on manufacturing efficiency rather than pricing power.

The 2001 HIV/AIDS decision was the most dramatic expression of this logic, but not an aberration from it. By then, Cipla had been building the manufacturing infrastructure, supply chain capabilities, and regulatory approvals that made the offer credible. When Dr. Yusuf Hamied said his company could supply antiretrovirals at $350 per year, he wasn’t bluffing. He was quoting from a cost structure that decades of purpose-driven operational investment had made real.

Within four years, Cipla was supplying nearly 40% of all HIV/AIDS medications reaching the developing world — a figure cited in Cipla: Expanding Horizons and requiring independent verification before publication. The volumes were enormous. The margins were thin. The profits were substantial.

For any business leader convinced that social mission and commercial success require trade-offs, Cipla’s trajectory is the most effective counter-argument available.

Lesson Two: Protect the Core. Expand the Perimeter

In 1935, Cipla made aspirin affordable. By the 2020s, it was manufacturing biosimilars, sterile oncology injectables, fixed-dose antiretroviral combinations, and next-generation respiratory inhalers. The product portfolio had expanded beyond recognition. The core had not moved an inch.

That core — the commitment to making complex medicines accessible, reliably, at scale — functioned as the organizing principle for every strategic decision Cipla made about where to grow and where not to.

Jim Collins’ Hedgehog Concept, introduced in Good to Great, holds that exceptional organizations identify the single thing they can be genuinely best at and ruthlessly organize around it. Cipla’s hedgehog was never generics. It was affordable access to complex medicines. Generics were one expression of it. Biosimilars would become another. Respiratory dominance would become a third.

This distinction allowed Cipla to upgrade its ambitions without abandoning its identity. As patents expired on simple oral generics and commodity competition intensified — Chinese manufacturers entering with even lower cost structures, pharmacy benefit managers consolidating buying power — Cipla moved deliberately up the complexity spectrum. Modified-release formulations. Sterile injectables. Inhaler devices. Oncology products. Biologics. Each step required new capabilities. Each step was also a defensible extension of the original mission: bringing therapeutically sophisticated medicines within reach.

The contrast with companies that diversify impulsively is instructive. Cipla never chased revenue growth into unrelated domains. It did not become a consumer goods company, or a diagnostics firm, or a digital health startup. Every expansion was a harder version of the same problem it had always been solving.

When it entered the US market — one of the most demanding regulatory environments in the world, requiring Abbreviated New Drug Applications, FDA facility inspections, and clinical bioequivalence data — it did so because complex generics for American patients fit precisely within Cipla’s core competency. The geography changed. The thesis did not.

Lesson three: Technical difficulty is a competitive advantage — If you invest early enough

Cipla’s relationship with respiratory medicine stretches back to 1978, when the company launched early inhaled products for the Indian market. But it was in the 1990s that Cipla made the strategic decision that most of its peers considered unnecessary: to scale aggressively and become the world’s leading generic manufacturer of inhaled respiratory medicines.

This was not an obvious move. Respiratory inhalers — metered-dose inhalers, dry powder inhalers, nebulizer solutions — are among the most technically demanding pharmaceutical products to develop and manufacture. Drug particles must be engineered to precise aerodynamic diameters, typically between one and five microns, to reach the small airways of the lungs. The devices themselves must dispense consistent doses across a range of patient inhalation flows. Demonstrating bioequivalence to a branded inhaler requires not just pharmacokinetic blood studies but in-vitro cascade impactor testing and, frequently, clinical endpoint trials.

The investment required to develop a single inhaler product in the 1990s exceeded $10 million and took several years. Most generic companies found it simpler and cheaper to compete in oral solid-dose generics and leave respiratory to the multinational giants — GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim.

Cipla read this differently. The same technical barriers that deterred competitors would, once overcome, protect margins and create defensible market positions. The company established specialized respiratory research facilities, recruited aerosol scientists and pharmaceutical engineers, invested in cascade impactors and laser diffraction instruments and environmental testing chambers, and began building proprietary inhaler device platforms.

The payoff was generational. By the time the major respiratory patents began expiring in developed markets, Cipla had more than two decades of aggressive scaling — and over forty years of respiratory experience — behind it. It was not a late entrant scrambling to reverse-engineer someone else’s device. It was the company to which regulators, hospital procurement teams, and generic distributors turned because no one had done the work longer or more seriously.

The global market for asthma and COPD medications exceeds $50 billion annually. Cipla became a dominant generics supplier in this market not because it was lucky, or because it moved quickly at the right moment, but because it had been building respiratory capability since the late 1970s and committed to scaling that capability globally in the 1990s — and held its nerve through both decisions.

That is a different kind of strategic patience from what most quarterly-reporting corporate structures reward. It is also the kind that builds genuinely durable competitive positions.

Lesson Four: Regulatory Compliance Is Not a Cost — It’s a Moat

In many industries, regulation is experienced primarily as burden: compliance costs, approval timelines, inspection anxiety. Cipla’s history suggests a more sophisticated interpretation — that regulatory excellence, when pursued proactively and at the highest global standard, functions as a competitive moat that takes competitors years or decades to replicate.

The US FDA represents the most demanding pharmaceutical regulatory environment in the world. Gaining FDA approval for a generic product requires extensive bioequivalence data, detailed manufacturing process documentation, and facility inspections that can result in warning letters, import bans, or consent decrees if deficiencies are found. Indian pharmaceutical companies in particular have faced high-profile FDA warning letters in recent decades, creating market disruptions that damaged competitors’ US ambitions.

Cipla’s approach was to build its quality systems to FDA and EMA standards regardless of the intended destination market. Products being manufactured for Nigeria or Uganda were produced in facilities that could withstand an FDA inspector’s scrutiny. This single-standard approach added cost in the short term. Over time, it meant that pivoting to regulated Western markets was a strategic option rather than a multi-year infrastructure project. It also meant that when regulatory scrutiny intensified globally — on data integrity, sterility, nitrosamine impurities, serialization — Cipla was already ahead of the requirements rather than scrambling to catch up.

There is a broader management principle here. In regulated industries, the companies that treat compliance as a floor — the minimum required to avoid penalty — remain permanently vulnerable to regulatory change and competitively constrained. The companies that treat compliance as a ceiling of their own making — investing to standards that exceed what is currently required — build structural advantages that compound over time.

Cipla’s regulatory capability extended beyond internal quality systems. The company developed the organizational muscle to manage simultaneous regulatory submissions across dozens of countries: the US FDA, the European Medicines Agency, South Africa’s regulatory authority, Brazil’s ANVISA, national health ministries across Sub-Saharan Africa. Each jurisdiction had different documentation requirements, approval timelines, and quality standards. Managing this regulatory complexity at scale — tracking filings, responding to queries, maintaining compliance post-approval — required capabilities that smaller competitors could not easily replicate.

When Cipla entered a new geography, the regulatory approval was often the hardest part for competitors to copy. The molecule could be reverse-engineered. The manufacturing process could be approximated. The regulatory track record — the relationships, the institutional knowledge, the documented history of compliance — took years to build from scratch.

Lesson Five: Volume Over Margin Is a Strategy, Not a Compromise

Every business school teaches margin management. Fewer explicitly teach the strategic logic of the volume-over-margin model — and when they do, they often frame it as a last resort for commoditized products in price-competitive markets.

Cipla built an empire on it deliberately.

The company’s pricing philosophy — rooted in the founding commitment to accessibility — consistently prioritized selling to more patients over extracting maximum margin from each transaction. Where Cipla held pricing power through limited competition, it typically priced below what the market would bear. The preference was always for 10 million units at a one-dollar margin over 1 million units at a five-dollar margin, even when the latter offered higher percentage returns.

This is not altruism dressed up as strategy. The economics are real.

Pharmaceutical manufacturing exhibits pronounced economies of scale. Fixed costs — facilities, quality systems, regulatory overheads, R&D amortization — are spread across higher volumes, reducing per-unit cost. Higher utilization of manufacturing assets improves returns on capital. Distribution networks serving large volumes become more efficient per unit. Suppliers offer better pricing to high-volume buyers.

The volume model also produces strategic benefits that don’t appear on a unit-economics spreadsheet. Governments and institutional health programs — the procurement bodies that in many developing-country markets represent the largest buyers of essential medicines — prefer suppliers who can deliver at scale reliably. Once Cipla became the trusted high-volume supplier to national procurement programs in Africa, the relationship was self-reinforcing. Scale delivered reliability. Reliability justified preference. Preference sustained scale.

Cipla’s HIV/AIDS experience crystallized this logic definitively. Charging $350 per patient per year when competitors charged thirty times more was not financial suicide. Treating millions of patients at thin margins produced a business large enough to fund the R&D, manufacturing investments, and regulatory work that kept Cipla at the frontier of pharmaceutical capability.

The lesson for businesses in other sectors is that the volume-over-margin choice involves accepting a different kind of competitive game — one where operational excellence, manufacturing efficiency, and market scale matter more than pricing power or customer captivity. Companies that choose this game deliberately, and invest accordingly, can build positions that are genuinely difficult to dislodge.

Lesson Six: Culture Is What Holds When Everything Else Is Under Pressure

The pharmaceutical industry is routinely tested by crises that have no clean answers: patent disputes, regulatory failures, supply disruptions, ethical controversies. How companies behave in these moments reveals more about their actual values than any mission statement.

Cipla has faced its share of crucibles. The HIV/AIDS pricing controversy of 2001 was perhaps the most visible — a moment when the company’s interests, the pharmaceutical industry’s interests, and the interests of millions of dying patients were in direct conflict. Dr. Yusuf Hamied did not equivocate. He was publicly, forcefully unapologetic. He argued before international audiences that patents on life-saving medicines were being used to condemn millions to preventable deaths. He challenged the industry’s R&D cost justifications. He named the tension plainly: intellectual property rights versus human lives, and he had made his choice.

This was not merely courageous. It was culturally consistent. The organization Cipla’s founder had built in 1935 — the one that chose to make aspirin affordable when British companies priced it as a luxury — was the same organization that offered antiretrovirals at $350 in 2001. The values hadn’t changed. The stakes had increased by several orders of magnitude.

For the employees of Cipla, this consistency is not a small thing. Organizations whose stated values and actual decision-making are aligned attract and retain a different kind of talent — professionals who want their work to carry meaning beyond the monthly paycheck. Cipla has consistently been able to recruit serious scientists, regulatory experts, and operations professionals partly because the mission is credible. You can work here and tell people what you do without qualification.

The organizational culture also created resilience under regulatory stress. When FDA inspections produced warning observations, when quality incidents required investigation, when supply chain disruptions threatened delivery to critical markets — the response came from an organization whose identity was defined by getting medicines to patients reliably. The quality culture wasn’t an overlay on a profit culture. It was the original culture, established by a scientist-founder who understood that quality failure in medicines was a patient harm, full stop.

Peter Drucker’s observation that culture eats strategy for breakfast applies here with particular force. Cipla’s strategies evolved continuously across nine decades — different markets, different products, different regulatory environments, different competitive dynamics. What remained constant was the culture: the belief that pharmaceutical access is a right, that quality is non-negotiable, and that volume serving the many is preferable to margin extracted from the few.

That constancy is not nostalgic inertia. It is structural advantage.

Conclusion: What Nine Decades Actually Teaches

Cipla turns 91 this year. It has outlasted colonial pharmaceutical monopolies, navigated Indian patent law reforms, survived the AIDS-era battle with the global pharmaceutical establishment, and built a $3-billion-plus enterprise that now competes credibly in the most demanding regulated markets on earth.

The temptation when examining such a company is to abstract the lessons into universal principles — have a mission, invest in quality, think long-term — and present them as a checklist. That would be a disservice to what Cipla actually demonstrates.

What Cipla demonstrates is that these principles are not compatible with every business model. They require specific choices: to price for access rather than maximum extraction; to invest in capabilities a decade before they pay; to hold a regulatory standard higher than the market currently requires; to let the founding purpose constrain every subsequent strategic decision.

Those choices are difficult. They require conviction that the long-term logic will hold, even when quarterly pressures push in other directions. They require a leadership culture capable of making large, uncomfortable decisions — like offering antiretrovirals at $350 in a room full of people who had decided $10,000 was immovable.

The world does not run short of companies that profess values. It runs short of companies that build a business model around them.

Cipla’s nine-decade record is evidence that the second kind of company is possible, and that it tends, in the fullness of time, to prove more durable than the first.

Vijay Martis is a business author whose writing examines Indian enterprise, strategy, and the companies shaping the subcontinent’s commercial future. He is the author of Cipla: Expanding Horizons.

The proposed acquisition will add several anti-inflammatory candidates to Biogen’s portfolio, including RayThera’s lead asset, which is anticipated to progress to Phase I clinical development in the early third quarter of 2026.

RayThera’s drug pipeline focuses on treating immune-mediated conditions across several potential indications.

Upon completion of the transaction, Biogen will assume responsibility for the development, manufacturing, and global commercialisation of these assets.

Biogen executive vice-president and development head Priya Singhal said: “With this acquisition, we are further deepening our pipeline in immunology by adding a suite of assets that can allow us to expand into new disease areas.

“We believe these assets can meaningfully contribute to our long-term pipeline potential and we’re excited about the opportunity to rapidly advance the first candidate into the clinic.”

RayThera co-founder, chairman and CEO Qing Dong said: “With its strong global development capabilities in immunology, we believe that Biogen is the natural fit to move these assets forward into Phase I development and beyond.

“I am proud of our team at RayThera for the innovative pipeline we have built together and the rapid advancement of these molecules.”

The transaction remains subject to customary closing conditions, including necessary regulatory approvals, and is expected to close in the third quarter of 2026.

RayThera recently completed its Series A funding round, which was co-led by OrbiMed Advisors and Foresite Capital, with participation from TTM Capital.

Earlier this month, Biogen received a breakthrough therapy designation from the US Food and Drug Administration for salanersen (BIIB115), an investigational treatment for spinal muscular atrophy.

The post Biogen to acquire RayThera for up to $1bn appeared first on Pharmaceutical Business review.

This joint effort aims to create immunotherapies to selectively trigger immune responses in the tumour microenvironment while limiting effects on healthy tissues.

TCEs have shown potential in treating various cancers, but the widespread activation of immune responses carries a risk of systemic toxicity.

The new arrangement between Voro Therapeutics and Alloy centres on finding approaches that may enhance the therapeutic index of TCE therapies.

Through this effort, both entities seek to address limitations that have restricted the broader use of immune-based cancer treatments.

Voro Therapeutics co-founder and CEO Dr Ugur Eskiocak said: “T-cell engagers have shown tremendous promise, but their broader impact has been constrained by the same challenge facing many powerful immune therapies: how to deliver potency without unacceptable systemic toxicity.

“We believe tumour-activated T-cell engagers represent the next evolution of the field. By combining Voro’s PrimeBody platform and TCE design expertise with Alloy’s discovery and multispecific engineering capabilities, we aim to create highly potent, tumour-selective therapies that broaden access for patients.”

The collaboration highlights ongoing efforts by both companies to advance biologic medicines and to investigate new T-cell engager approaches that could expand patient access.

Voro Therapeutics is developing precision biologics designed to activate selectively in diseased tissues through its PrimeBody platform.

Its lead candidate, a conditionally activated CD47 inhibitor, is advancing through investigational new drug-enabling studies following preclinical investigations.

Alloy Therapeutics CSO Mike Schmidt said: “By integrating Voro’s differentiated linker and masking technologies with Alloy’s optimised CD3 antibodies and cell engager engineering expertise, we can accelerate the development of next-generation TCE’s with potentially best-in-class safety and efficacy.”

The post Voro and Alloy partner on tumour-selective TCE therapeutics appeared first on Pharmaceutical Business review.

DIA (Drug Information Association), a global community of life sciences professionals, will host the DIA Medical Writing & Scientific Communications Conference 2026 on July 10–11, 2026, in Bengaluru, India.

The two-day conference will bring together pharmaceutical companies, Global Capability Centers (GCCs), Contract Research Organizations (CROs), and communication experts to explore evolving regulatory requirements, publication practices, patient-centric communication, and responsible AI adoption. The conference will also bring together leaders from healthcare industry, academia, and technology providers to discuss the future of medical writing and scientific communication.

The conference theme is “Redefining Medical Writing Practices: Global Insights, Local Excellence, and Future Frontiers.” It will examine how medical writing is evolving amid regulatory harmonization, increasing demands for transparency, advances in artificial intelligence, and the growing importance of patient-focused communication.

“Medical writing is no longer viewed solely as a documentation function. It has become a strategic capability that supports regulatory decision-making, scientific exchange, evidence communication, and patient engagement,” said Dr. Ashok Swain, General Manager & Executive Director, DIA India. “This conference will provide a platform for professionals across the healthcare ecosystem to share perspectives, address emerging challenges, and explore innovative approaches that strengthen the quality and impact of scientific communication.”

The conference programme will cover regulatory writing, scientific publications, quality and compliance, real-world evidence communication, AI governance, digitisation and automation, and patient-centric communications. It will also include discussions on emerging GCC operating models, talent development strategies, and collaboration frameworks between pharmaceutical companies, CROs, and service providers.

“The medical writing profession is experiencing a period of significant transformation driven by technology, evolving stakeholder expectations, and increasingly complex regulatory requirements,” said Pooja Phogat, PhD, Program Chair, DIA India Medical Writing Community and Founder & Co-CEO, Krystelis Ltd. “This meeting has been designed to facilitate practical discussions and knowledge exchange that help professionals navigate change while maintaining scientific rigor, quality, and compliance.”

As India continues to strengthen its position as a global hub for medical writing and scientific communication, the conference aims to foster collaboration, share best practices, and advance professional excellence across the industry.

Registration for the DIA Medical Writing & Scientific Communications Conference 2026 is now open. For more information on the conference and participation details, visit the official DIA website.

The project focuses on the joint discovery and development of oral peptide therapeutics, drawing on AI technology and expertise in peptide formulation.

Peptides play a key role in physiological functions but are typically administered via injection due to their susceptibility to breakdown in the digestive system.

The companies aim to create a tablet-form treatment using AI to improve both the safety and absorption rates of peptide drugs, targeting conditions that currently lack effective therapies.

Under the partnership, LG AI Research will develop models to design and discover new peptide drug candidates.

These models are intended to analyse disease-causing substances at scale and identify optimal peptide sequences, aiming to address challenges that conventional methods have not overcome.

D&D Pharmatech will be responsible for the structural design, synthesis, and evaluation of the selected candidates, as well as formulation for oral administration, and will manage preclinical and clinical development along with global regulatory interactions.

The companies intend to collaborate through a feedback system, in which LG AI Research provides AI-generated candidates that D&D Pharmatech then validates, with the results informing further modelling improvements.

Lim said: “This collaboration goes beyond the simple adoption of technology; it represents a journey toward creating a bio-specialised AI that addresses complex challenges in drug discovery.

“Through continuous advancements in our protein engineering models, we are actively accelerating the development and optimising the design of next-generation peptide therapeutics.”

In addition to this project, LG AI Research is involved in developing other AI-based biotechnology platforms, including oncology analysis tools and the EXAONE Discovery platform for accelerated drug and material research.

The post LG AI Research and D&D Pharmatech sign agreement for oral peptide drugs appeared first on Pharmaceutical Business review.

It also includes the potential for up to $792m for each programme in option fees and milestone payments if Jazz Pharmaceuticals exercises its options to develop and commercialise any resulting therapeutic antibodies.

The collaboration gives Jazz Pharmaceuticals exclusive worldwide rights to develop and commercialise therapeutic antibodies emerging from the partnership.

AbCellera will conduct discovery and early-stage research activities on two initial programmes, with a commitment to starting a third within the next year.

The companies may also agree to initiate as many as two further programmes, and AbCellera may perform certain investigational new drug-enabling studies and manufacture clinical supplies for any of the programmes.

AbCellera’s platform for TCEs integrates discovery with clinical manufacturing and includes panels of CD3-binding antibodies, co-stimulatory targeting mechanisms, multispecific protein engineering, and a series of high-throughput functional assays.

AbCellera founder and CEO Carl Hansen said: “Building on years of experience in TCEs, we are pleased to partner with Jazz Pharmaceuticals to leverage AbCellera’s differentiated TCE platform to bring forward novel cancer treatments for GI cancers and other solid tumours.”

Jazz Pharmaceuticals oncology chief scientific officer Josh Allen said: “This research collaboration with AbCellera directly aligns with Jazz’s rare disease strategy, expanding our focus on GI cancers and building on our existing expertise in oncology.

“We look forward to collaborating with AbCellera to progress potential best-in-class TCE multispecific antibodies for GI cancers and other solid tumours into clinical development and to develop meaningful innovation for patients.”

The post Jazz and AbCellera sign deal for T-cell engagers in solid tumours appeared first on Pharmaceutical Business review.

Regulatory transparency is not merely administrative preference but a fundamental driver of pharmaceutical industry progress, public health protection, and economic development. USFDA and EUDRA models provide proven frameworks India can adapt to its regulatory context, advancing pharmaceutical leadership while protecting public health and industry innovation.

The United States Food and Drug Administration (USFDA) and the European Medicines Agency (EMA) through its EUDRA platform maintain extensive public dashboards providing unprecedented transparency into pharmaceutical regulatory processes. These platforms offer detailed information on drug approvals, clinical trials, manufacturing inspections, adverse events, and compliance status largely unavailable through India’s Central Drugs Standard Control Organization (CDSCO), Director General of Central Services (DCGI), and state FDA websites. This analysis examines specific information differences, evaluates benefits to industry and public, identifies disadvantages of public data accessibility, and demonstrates how transparent regulatory information promotes pharmaceutical industry progress.

PART 1: INFORMATION ON USFDA AND EUDRA DASHBOARDS VS. INDIAN REGULATORY WEBSITES

1.1 USFDA Public Dashboards: Comprehensive Information Categories

USFDA maintains multiple interconnected databases to provide remarkable transparency into pharmaceutical regulatory processes.

Drugs@FDA Database: USFDA’s primary portal, gives detailed information on approved human drugs and biological therapeutic products approved since 1939.

1. Drug Information and Regulatory History: Complete details including drug name, active ingredients, dosage form, route of administration, strength, and comprehensive regulatory history from initial application through all variations.
2.  FDA-Approved Prescribing Information: Labeling and patient labeling, representing official approved documents for physician prescribing decisions.
3.  FDA Staff Reviewed Documents: Evaluating safety and effectiveness, providing transparency into regulatory decision-making and scientific rationale.
4.  Approval Letters: Official documentation of FDA approval decisions with dates and conditions.
5.  Regulatory Application Numbers: NDA (New Drug Application), BLA (Biologics License Application), and ANDA (Abbreviated New Drug Application) numbers for tracking.
6.  Patent and Exclusivity Information: Patent numbers, expiration dates, and exclusivity periods informing generic developers about freedom-to-operate.

FDA Adverse Event Reporting System (FAERS) Dashboard

Provides specific information on adverse event and medication error reports submitted to FDA.

1. Adverse Event Reports: Comprehensive data on adverse drug reactions reported by manufacturers, patients, health professionals.
2. Medication Error Reports: Documentation of medication errors resulting in adverse events.
3. Searchable Dashboard: User-friendly search tool enabling data search by drug/biological product, patient age, event type, year, or timeframe.
4. Post-Marketing Safety Surveillance: Supports FDA’s post-marketing safety surveillance program.

Orange Book (Approved Drug Products with Therapeutic Equivalence)

Provides information on therapeutic equivalence evaluations essential for generic development.

1. Therapeutic Equivalence (TE) Codes: Indicate therapeutic equivalence ratings of generic to innovator products.
2. Complete List of Approved Drug Products under the Federal Food, Drug, and Cosmetic Act.
3. Patent Information: Patent numbers and expiration dates integrated with approval data.

Bioequivalence (BE) Recommendations for Specific Products

This essential database guides generic drug development bioequivalence studies.

Specific Information: BE study design guidance, product-specific recommendations ensuring generic drugs equal brand-name counterparts, regulatory compliance pathway for ANDA approval.

FDA Inspections Database

Provides specific information and unprecedented transparency into manufacturing compliance.

1. Facility Inspection Records of Regulated Facilities: Depicting compliance.
2. Compliance Status Public Disclosures: Provide rationale for enforcement actions.
3. Public Health Protection Information: improves public understanding of FDA’s public health work.
4. Marketplace Decision-Making: Informing public and industry making informed marketplace choices.

Searchable Warning Letters Database

Provides specific information and transparency into regulatory enforcement actions viz. Complete FDA-issued Warning Letters with search by keyword, company, date, issuing office, subject.

Other Key Databases:

• National Drug Code (NDC) Directory: Drug listing information for prescription drugs.
• Inactive Ingredient Search: Complete information on inactive ingredients in approved drugs.
• Post-market Requirements Database: Post-market studies sponsors must conduct after approval.
• Clinical Investigator Inspection List (CLIIL): Inspection records of clinical investigators.
• Debarment List: Firms/persons disqualified from drug development.

1.2 EUDRA/EMA Public Dashboards: European Regulatory Transparency

The European Medicines Agency maintains EudraGMDP database and EU Clinical Trials Register.

EudraGMDP Database: Community database on manufacturing, import, wholesale-distribution authorisations, and GMP/GDP certificates provides following specific information.

1. Manufacturing and Import Authorisations: Complete list for active substances and pharmaceutical products.
2. GMP Certificates: Issued by European Economic Area authorities.
3. Public Statements of Non-Compliance with GMP standards.
4. Comprehensive Searchability by company name, location, certificate number.
5. Contract Manufacturer Verification: Quick reference for checking GMP compliance.
6. Medicine Distribution Chain Protection: Verifying legitimate actors protecting medicine supply chains.

EU Clinical Trials Register (EudraCT)

Provides public access to European Union clinical trial database information.

Specific Information Provided:

1. Clinical Trial Complete Descriptions: Phase II-IV adult clinical trials description in EU Member States.
2. Pediatric Clinical Trials: with investigator sites in EU.
3. Trial Design Information: Comprehensive details on trial design, methodology, endpoints.
4. Sponsor Identification: Complete sponsor information.
5. Trial Status: Current status (authorised, ongoing, complete).
6. Data from May 2004: Information available from 1 May 2004.

European Public Assessment Reports (EPARs)

Provide detailed scientific assessment information for EMA-approved medicines giving specific information viz Summary of Product Characteristics, full assessment reports, post-authorisation studies, weekly updates.

1.3 Indian DCGI/CDSCO and State FDA Websites: Limited Public Transparency

India’s regulatory infrastructure provides relatively lesser public transparency.

SUGAM Portal (CDSCO) is CDSCO’s online platform for license and application processing.

Information is provided primarily for applicants, not public such as: 

1. Application Submission Interface: Single-window interface for stakeholders.
2. Application Tracking: Track application status.
3. Approval Download: Download approvals issued by CDSCO.

Critical Limitation: Designed primarily for applicant interaction, not public information access. No comprehensive public database of approved drugs with labels, approval letters, or review documents, patent information, inspection records comparable to Drugs@FDA.

Public Information Available on CDSCO Website:

1. Approved Drugs List Access: Guidance to visit official website, select categories like new drugs, FDC.
2. Guidance Documents: Draft guidance on clinical trials and new drugs as PDFs.
3. Guidelines and Circulars: Latest circulars, notices, guidelines.

Critical Limitations:

• No comprehensive searchable database with therapeutic equivalence evaluations.
• No publicly accessible prescribing information (labeling).
• No approval letters or review documents.
• No adverse event reporting database.
• No manufacturing inspection compliance status.
• No clinical trial results database.
• No GMP certificate public database.
• No warning letters database.
• No patent/exclusivity integration.

State FDA Websites Typically Provide Following Information

1. License Database: Database of permissions and licenses primarily for licensee interaction.
2. Limited Public Access: Limited or insignificant information available to public on various facets as listed above.

Critical Limitations: No standardised public database, no inspection compliance disclosure, no adverse event reporting, no clinical trial information, no GMP certificates, no drug labeling.

1.4 Comparative Summary: Information Gap

PART 2: BENEFITS OF USFDA/EUDRA INFORMATION TO INDUSTRY AND PUBLIC

2.1 Benefits to Pharmaceutical Industry

2.1.1 Generic Drug Development Acceleration

Orange Book Therapeutic Equivalence (TE) Information Enables Efficient Development

TE codes provide generic manufacturers critical information determining therapeutic equivalence viability:

• Reduces Development Uncertainty: Generic developers know immediately if FDA considers product route viable.
• Accelerates Approval Timeline: Clear TE information focuses resources on products with confirmed pathways.
• Optimises Resource Allocation: Companies prioritise ANDA submissions for products with favorable TE ratings.

Bioequivalence Recommendations Eliminate Study Design Errors

Product-specific BE guidance:

• Prevents Study Failures: Guidance ensures applicants design studies per FDA expectations.
• Reduces Regulatory Cycles: Properly designed studies receive approval in fewer cycles.
• Standardises Development: Clear guidance creates consistent development approaches.

Inactive Ingredient Database Prevents Formulation Problems

• Avoids Regulatory Rejection: Knowing approved inactive ingredients prevents unacceptable formulations.
• Accelerates Development: Formulators immediately identify allowable excipients.

2.1.2 Freedom-to-Operate and Patent Strategy

Patent Information Integration Enables Strategic Planning

Drugs@FDA and Orange Book patent integration:

• Patent Expiration Tracking: Monitor patent expiration for reference products, planning generic entry.
• Exclusivity Period Awareness: Understanding exclusivity prevents premature ANDA submissions.
• Freedom-to-Operate Analysis: Comprehensive patent data assesses generic development legal viability.
• Litigation Risk Assessment: Patent information evaluates litigation risks before development investment.

2.1.3 Manufacturing and Supply Chain Optimisation

GMP Certificate Database Enables Contract Manufacturer Selection

EudraGMDP GMP certificate information:

• Contract Manufacturer Verification: Quickly verify GMP compliance by searching company, location, certificate.
• Supply Chain Risk Reduction: GMP visibility reduces contamination and compliance risks.
• International Manufacturing: Third-country GMP information facilitates international partnerships.

Inspection Compliance Status Information and Manufacturing Decisions

USFDA Inspections Database:

• Facility Selection Intelligence: Select manufacturing facilities based on disclosed compliance.
• Quality Risk Assessment: Compliance disclosure enables quality risk assessment.

2.1.4 Clinical Development Efficiency

Clinical Investigator Database Optimises Trial Site Selection

Bioresearch Monitoring Information System (BMIS) and Clinical Investigator Inspection List CLIIL databases:

• Investigator Qualification Verification: enables verification of qualifications and compliance before site selection.
• Data Validity Assurance: Clinical investigator inspection history ensures trial data validity.

Clinical Trial Register Enables Competitive Intelligence

EU Clinical Trials Register:

• Competitor Trial Monitoring: Enables monitoring competitor clinical trial activities.
• Trial Design Benchmarking: Trial designs enable benchmarking.
• Market Opportunity Assessment: Therapeutic area information identifies opportunities.

2.1.5 Regulatory Submission Quality

Review Document Access Improves Submission Quality

FDA review documents:

• Understands Approval Criteria: Reviews reveal FDA’s safety/effectiveness evaluation criteria.
• Improves Data Presentation: Understanding review expectations improves data presentation.
• Reduces Regulatory Questions: Anticipating concerns reduces questioning cycles.

Warning Letters Database Prevents Compliance Errors

• Identifies Common Violations: Identify common violations to prevent in operations.
• Compliance Priority Setting: Warning letter patterns inform compliance priorities.

2.2 Benefits to Public and Patients

2.2.1 Patient Safety Protection

FDA Adverse Event Reporting System (FAERS) searchable dashboard Enables Safety Awareness

• Drug Safety Information: Patients and providers access comprehensive adverse event data.
• Safety Pattern Recognition: Searchable by drug, age, event type enables pattern recognition.
• Post-Marketing Surveillance: Public access to post-marketing safety surveillance.

Inactive Ingredients Guide (IIG) or Inactive Ingredient Database (IID)Prevents Allergic Reactions

• Allergy Prevention: Patients with allergies identify dangerous inactive ingredients.
• Patient Empowerment: Transparent ingredient information empowers safe choices.

GMP Certificate Verification Ensures Product Quality

• Quality Assurance: Patients verify manufacturing quality through GMP access.
• Non-Compliance Awareness: Public non-compliance statements alert to quality issues.

2.2.2 Informed Medication Selection

Drugs@FDA Prescribing Information Access Supports Decision-Making

• Complete Drug Information: Patients access FDA-approved prescribing information.
• Safety-Efficacy Understanding: Review documents explain safety/effectiveness evaluations.
• Contraindication Awareness: Labeling reveals contraindications and warnings.

Therapeutic Equivalence (TE) Codes Guide Generic Selection: 

• Generic Confidence: TE codes confirm therapeutic equivalence to reference products.
• Cost-Saving Decisions: Patients confidently select therapeutically equivalent generics.

2.2.3 Clinical Trial Transparency

Clinical Trial Register Enables Participation Awareness

• Trial Availability Awareness: Patients identify available clinical trials.
• Trial Design Understanding: Trial descriptions explain design, endpoints, methodology.
• Status Tracking: Trial status informs participation timing.

2.2.4 Healthcare Professional Decision Support

Comprehensive Drug Information Supports Practice

• Evidence-Based Practice: Review documents provide evidence base for prescribing.
• Therapeutic Equivalence Guidance: TE codes support generic substitution.
• Safety Information: Adverse event data informs safety monitoring.

PART 3: DISADVANTAGES OF MAKING REGULATORY INFORMATION PUBLICLY ACCESSIBLE

3.1 Commercial Confidentiality Concerns

3.1.1 Window of opportunity to decode secrets: Formulation Details Risk Competitor Free-Riding

• Formulation Reverse Engineering: Detailed inactive ingredients enable reverse engineering.
• Competitive Free-Riding: Competitors free-ride on innovator investment without costly development.

Clinical Trial Design Intellectual Property

• Trial Design Copying: Competitors copy trial designs without investment.
• Endpoint Strategy Exposure: Trial endpoints become publicly available.

3.1.2 Business Strategy Disclosure: Post-market Commitments Reveal Strategic Plans and Study timelines enable competitors to understand market entry strategies.

3.2 Personal Privacy Concerns

3.2.1 Patient Data Protection

FAERS database and Adverse Event Reports May Contain Personal Information that has

• Patient Identity Risk: Reports may contain identifiable information despite anonymisation.
• Health Condition Disclosure: Adverse events reveal patient health conditions.
• GDPR/HIPAA Compliance: Database access must comply with data protection regulations.

Clinical Trial Participant Privacy

• Participant Identification: Trial descriptions may enable identification in small trials.
• Health Condition Disclosure: Therapeutic areas reveal participant health conditions.

3.2.2 Investigator and Staff Privacy

Clinical Investigator Information may include

• Investigator Personal Information: Personal contact details.
• Professional Reputation Impact: Inspection findings impact professional reputation.

3.3 Misinformation and Misinterpretation Risks

3.3.1 Adverse Event Data Misinterpretation

FAERS Data Limitations

• Causality Misunderstanding: Public may misunderstand reports don’t establish causality.
• Risk Overestimation: Raw numbers may lead to overestimation of drug risks.
• Context Missing: Reports lack patient population and background rate context.
• Unnecessary Discontinuation: Misinterpreted data may cause unnecessary medication discontinuation.

3.3.2 Clinical Trial Information Misinterpretation

• Completion Misunderstanding: Public may misunderstand trial status.
• Efficacy Assumption: Trial initiation misinterpreted as evidence of efficacy.
• Methodology Misunderstanding: Public may not understand complex trial methodology.

3.4 Competitive Market Distortions

3.4.1 Generic Entry Acceleration

Patent Expiration Information Enables Aggressive Generic Planning for Precise Generic Entry and Accelerated entry may disrupt innovator strategies and Accelerated competition reduces innovator revenue.

3.5 Regulatory Resource Burdens

3.5.1 Database Maintenance Costs

• Infrastructure Costs: Maintaining searchable databases requires significant investment.
• Update Resources: Regular updates require dedicated staff.
• Data Quality Assurance: Verification requires significant staff resources.

3.5.2 Privacy Protection Burdens

• Anonymisation Requirements: Anonymising personal information requires significant processing.
• Compliance Monitoring: Ongoing data protection compliance monitoring requires resources.

3.6 Security Concerns

3.6.1 Supply Chain Security

Facility Information Exposure

• Facility Location Disclosure: Public facility information may expose security vulnerabilities.
• Supply Chain Targeting: Competitors can identify supply chain vulnerabilities.

Part 4: TRANSPARENT REGULATORY INFORMATION PROMOTES PHARMACEUTICAL INDUSTRY PROGRESS

4.1 Accelerating Innovation Through Reduced Uncertainty

4.1.1 Development Pathway Clarity

Public FDA Review Documents Reduce Regulatory Uncertainty

• Approval Criteria Transparency: Scientists understand FDA’s evaluation criteria, reducing uncertainty.
• Data Requirement Clarity: Reviews clarify data requirements, preventing unnecessary collection.
• Risk Reduction: Understanding review expectations reduces regulatory rejection risk.

Bioequivalence Guidance Streamlines Generic Development

• Study Design Confidence: Clear BE guidance enables confident study design.
• Development Acceleration: Clear guidance accelerates generic development.

4.1.2 Competitive Intelligence Enabling Strategic Innovation

Clinical Trial Register Supports Innovation Planning

• Competitive Landscape Understanding: Companies understand competitive activities / strategy.
• Therapeutic Opportunity Identification: Trial information identifies unmet needs.
• Resource Allocation: Competitive intelligence informs resource allocation.

4.2 Enhancing Quality Through Transparency

4.2.1 Manufacturing Quality Improvement

Inspection Disclosure Encourages Compliance

USFDA Inspections Database:

• Compliance Incentive: Public disclosure incentivises manufacturers to maintain compliance.
• Industry Learning: Companies learn from peer inspection findings.
• Quality Standards: Transparency establishes quality standards across industry.

GMP Certificate Verification Elevates Quality

• Contract Manufacturer Standards and Supply Chain Quality: GMP verification raises contract manufacturer and supply chain quality. 
• Quality Competition: GMP visibility creates quality competition.

4.3 Facilitating Competition and Access

4.3.1 Generic Drug Market Development

Therapeutic Equivalence Information Enables Competition

• Generic Entry Facilitation: TE codes enable confident generic entry.
• Price Competition: Facilitated entry creates price competition.
• Access Improvement: Generic competition improves medication access.
• Healthcare Cost Reduction: Price competition reduces healthcare costs.

Patent Information Enables Freedom-to-Operate

• Generic Planning: Patent information enables freedom-to-operate analysis.
• Entry Timing: Expiration dates enable optimal timing.
• Market Development: Clear patent information facilitates generic market development.

4.4 Building Regulatory Capacity Through Knowledge Sharing

4.4.1 International Regulatory Harmonisation

Inspection Information Sharing Supports Capacity

EudraGMDP international sharing:

• Regulatory Learning: Authorities learn from inspection outcomes improving capacity.
• Harmonisation: Information sharing promotes regulatory harmonisation.
• Standardisation: Shared information promotes standardisation.

4.5 Driving Economic Growth

4.5.1 Industry Investment Attraction

Transparency Builds Investor Confidence

• Predictable Environment: Regulatory transparency creates predictable investment environment.
• Risk Reduction: Reduced uncertainty attracts investment.
• Growth Confidence: Transparency builds confidence in industry growth.

4.5.2 Healthcare System Efficiency

Generic Competition Reduces Costs

• System Cost Reduction and Sustainability: Generic competition reduces healthcare system costs significantly and thus improves healthcare system sustainability.
• Resource Allocation: Cost savings enable resource allocation to innovation.

4.6 Promoting Public Health Outcomes

4.6.1 Safety Surveillance Enhancement

FAERS and Post-Marketing Monitoring

• Continuous Safety: Public adverse event data enables continuous safety monitoring.
• Early Warning: Transparency provides early warning for safety issues.
• Public Protection: Enhanced surveillance protects public health.

4.6.2 Treatment Optimisation

Comprehensive Drug Information: Drugs@FDA and European Public Assessment Reports (EPARs):

• Evidence-Based Treatment: Review documents support evidence-based treatment.
• Prescribing Quality: Complete information improves prescribing quality.
• Patient Outcomes: Better prescribing improves patient outcomes.

Conclusion:

The disparity between USFDA/EUDRA public regulatory dashboards and Indian CDSCO/State FDA websites represents a fundamental difference in regulatory philosophy. US and European systems prioritise unprecedented transparency with comprehensive public access to drug approvals, clinical trials, manufacturing inspections, adverse events, and compliance status. India’s regulatory infrastructure remains primarily applicant-focused with limited public information access.

The benefits of USFDA and EUDRA transparency are transformative. For industry, transparent information accelerates generic development through TE codes and BE guidance, enables strategic innovation through competitive intelligence, optimises manufacturing through GMP verification, and reduces regulatory uncertainty through review access. For the public, transparency protects patient safety through adverse event monitoring, enables informed medication selection through prescribing information, supports clinical trial participation, and ensures quality through GMP verification.

Public accessibility creates legitimate disadvantages: commercial confidentiality concerns and personal privacy risks in adverse event reports and trial participants, misinformation risks from data misinterpretation, competitive market distortions accelerating generic entry, regulatory resource burdens for database maintenance, and security concerns regarding supply chain vulnerability.

Despite disadvantages, transparent regulatory information fundamentally promotes pharmaceutical industry progress by accelerating innovation through pathway clarity, enhancing quality through manufacturing/transparency, facilitating competition and access, building regulatory capacity through knowledge sharing, driving economic growth through investment attraction, and promoting public health outcomes through safety surveillance.

For India’s pharmaceutical sector, playing role as “pharmacy of the world,” enhancing regulatory transparency through USFDA/EUDRA-style public dashboards would provide transformative benefits. Implementing comprehensive public databases for approved drugs with labels, approval letters, review documents, TE evaluations, adverse event reporting, manufacturing inspection compliance, clinical trial information, and GMP certificates would accelerate India’s pharmaceutical industry development, improve patient safety, enhance global regulatory standing, and support pharmaceutical leadership.

The path forward requires balancing transparency benefits with legitimate confidentiality and privacy concerns, implementing robust data protection, ensuring accurate information interpretation through education, and building regulatory capacity. Through thoughtful implementation of transparent regulatory information systems, India can unlock transformative benefits demonstrated by USFDA and EUDRA while protecting legitimate interests, advancing pharmaceutical progress and public health outcomes.

What is the long-term vision for Cyano Pharma over the next 5–10 years? Which business verticals will drive future growth, and what are currently the company’s strongest revenue-generating segments?

Cyano Pharma carries 60 years of trust, and my vision for the next decade is to honour that legacy while boldly evolving it. Today, our B2B pharmaceutical formulations business is our strongest revenue driver — it gives us a solid, reliable foundation that has stood the test of time.

Looking ahead, I see growth being driven by a deliberate and phased expansion into new verticals. Ayurveda is one area we are actively planning to enter in the future — India’s traditional medicine systems carry enormous global credibility, and a company with our pharmaceutical rigour is well-placed to bring real quality and scientific substantiation to that space.

Over the next 5–10 years, I want Cyano to be recognised not just as a pharma company, but as a science-backed, multi-vertical health enterprise — one that commands respect domestically and in WHO-recognised markets across the globe.

Are there plans for new manufacturing facilities, product categories, or technology investments?

Yes, and this is one of the most exciting chapters in Cyano’s journey right now. We are currently constructing a new manufacturing facility that will be WHO-GMP certified. This is a significant capital investment and a clear statement of intent — we are building for global markets, not just domestic scale.

On the product side, entering Ayurveda is firmly on our roadmap for the future. It is a category where we believe our pharmaceutical discipline and manufacturing standards can create something genuinely differentiated — but we are committed to entering it the right way, with the right infrastructure and quality foundations firmly in place.

These two moves — a WHO-GMP plant today, and an Ayurveda vertical on the horizon — define the next phase of Cyano’s growth story.

Are you planning to expand deeper into international markets? Which geographies look most promising?

International expansion is very much central to our growth strategy, and we are approaching it in a calibrated way. In the near term, we are actively evaluating West Africa as a priority market — and as we build that presence, we will naturally look to explore adjacent regions in the years ahead.

In the longer term, our ambition is to access WHO-recognised markets across the globe. That is a significant aspiration, and it is directly connected to our decision to construct a new WHO-GMP certified manufacturing plant. Global pharma markets demand quality consistency and regulatory compliance that cannot be retrofitted — you have to build it from the ground up. Our new plant is designed precisely with that global vision in mind.

How do you see AI and digital transformation shaping your company’s future?

We are already using AI extensively, and in areas that are delivering real, measurable operational value. Three specific areas stand out — data management, documentation, and our hiring process.

In data management and documentation, the impact has been immediate. Pharma is an intensely documentation-heavy industry, and AI tools have significantly reduced manual burden, improved accuracy, and freed up our teams to focus on higher-value work. In hiring, AI has brought more structure and consistency to how we evaluate candidates — which matters greatly as we scale.

What I find most compelling about AI is not just efficiency — it is the ability to make better decisions faster. As we expand into new markets and new verticals, the ability to synthesise information quickly and act on it with confidence will be a genuine competitive advantage. Companies that treat AI as a core operational capability rather than a peripheral tool will be the ones that lead.

Do you see stronger future growth in pharmaceuticals or beauty and wellness categories?

For Cyano, pharmaceuticals will remain our primary focus and our core strength for the foreseeable future. That is where our six decades of expertise lie, and that is the foundation we are continuing to invest in and scale — through our new WHO-GMP plant and our planned international expansion.

That said, I would be doing a disservice to the conversation if I did not acknowledge what is happening in the beauty and wellness space. The industry is growing at a remarkable pace, driven by a fundamental shift in how people think about health — from reactive treatment to proactive self-care.

Consumers today want products that sit at the intersection of efficacy and wellness, and that is creating real and lasting market opportunity. A company with pharmaceutical-grade manufacturing capabilities is naturally well-positioned to play in this space with credibility. It is not our current objective, but it is a space I watch closely and one that may well be part of Cyano’s longer-term story.

You’ve actively spoken about industry-academia collaboration. What gaps do you currently see between education and industry needs? Are pharma graduates industry-ready today?

This is a topic I feel very strongly about, and one I have moved from talking about to actually doing something about. The honest answer is that pharma graduates in India today are often very well-read but underprepared for the realities of professional life — and the gap is not primarily in knowledge, it is in thinking.

Four years of curriculum have largely been oriented around memorisation. What has been critically underdeveloped is logical reasoning, critical thinking, and analytical ability. Industry does not need people who can recite pharmacokinetics from memory; it needs people who can solve unfamiliar problems systematically.

I am cautiously optimistic, however. The Pharmacy Council of India has launched a revised, industry-aligned syllabus, and I believe we will begin to see a meaningful difference in the talent coming out of institutions over the next four years.

Communication is another significant gap. Many genuinely talented students cannot clearly articulate their ideas — in writing, presentations, or professional conversations. In a globalising industry, that is a serious handicap.

This is precisely why I launched MagnetJobs.in — an AI-powered platform built specifically to bridge the gap between pharma talent and pharma opportunity. It helps students develop interview skills, professional confidence, and access relevant opportunities, while helping companies identify suitable candidates more efficiently.

What has been your biggest learning as a business leader?

Joining a 60-year-old family business after working in a global MNC was one of the most humbling experiences of my professional life. At Nivea Beiersdorf, I had the comfort of clear processes, global best practices, and strong institutional support. At Cyano, I had legacy — which is both an asset and a responsibility.

My biggest learning has been this: respect what was built before you, but do not be imprisoned by it. There is immense wisdom in a business that has survived and grown for six decades. But there is also accumulated habit, comfort with the status quo, and natural resistance to change.

The leader’s job is to honour the foundation while building something new on top of it. That requires patience, humility, and the willingness to earn trust before demanding change.

I have also learned that leadership is far less about having the right answers and far more about asking the right questions — and creating an environment where people feel safe enough to answer honestly.

What advice would you give to young entrepreneurs entering pharma, cosmetics, or healthcare?

Three things I would tell my younger self.

First — go deep before you go broad. Spend time genuinely understanding one area of this industry, whether it is formulation science, regulatory affairs, supply chain, or clinical research. Breadth matters, but credibility is built on depth.

Second — do not underestimate the power of an unconventional combination. My path — pharma graduate, cosmetic technology master’s degree, FMCG R&D professional, and now leading a family pharma business while building a talent-tech venture — looked scattered at times. In hindsight, it is precisely that combination that allows me to connect dots others may miss.

Third — be patient with legacy, and bold with vision. Whether you are joining a family business or building something from scratch, understand that trust in healthcare is hard-won and easily lost. Build it deliberately. And then, from that foundation of trust, be genuinely bold about the future you want to create.

swati.rana@expressindia.com

swatirana.express@gmail.com

Lupin has announced the launch of Azilsartan Medoxomil Tablets, 40 mg and 80 mg, in the United States following approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA).

The company stated that the product is bioequivalent to Edarbi of Azurity Pharmaceuticals, Inc. and is indicated for the treatment of hypertension in adults to lower blood pressure.

Lupin is the exclusive first-to-file for the product and is eligible for 180-day generic drug exclusivity.

According to IQVIA MAT April 2026 data, Azilsartan Medoxomil Tablets (RLD Edarbi) recorded estimated annual sales of USD 53.5 million in the United States.

The vMiX platform leverages adeno-associated virus (AAV) as a delivery vector and harnesses the cell’s natural RNA interference process.

vMiX enables sustained silencing of disease-causing genes after a single dose.

The system can target up to three genes at once and includes an option to perform both silencing and replacement by incorporating an additional transgene within the construct.

For safety and precision, gene silencing can be localised to specific tissue or cell types through the use of tailored promoters.

This expanded licensing arrangement enables AviadoBio to explore strategic partnerships and collaborations for broader applications, including cardiovascular, nephrology, and oncology indications, as well as other fields outside its current central nervous system (CNS) portfolio.

AviadoBio CEO Lisa Deschamps said: “vMiX is a versatile RNAi platform with potential applications that extend well beyond the neurodegenerative indications where we have demonstrated its initial therapeutic potential.

“Expanding our vMiX licence positions us to maximise the value of vMiX as a platform technology while we maintain focus on advancing our core neuroscience pipeline.

“We see clear opportunities to partner with companies best positioned to advance vMiX-enabled programmes across cardiovascular disease, nephrology, oncology and other indications beyond our therapeutic focus.”

The announcement follows recent preclinical data for AVB-406, AviadoBio’s lead vMiX-enabled candidate.

The data, presented at the American Society of Gene & Cell Therapy 2026 Annual Meeting, showed up to 80% dose-dependent Microtubule-Associated Protein Tau (MAPT) knockdown in the brain.

AviadoBio has been developing its discovery engine for the vMiX platform since 2020, utilising in silico, in vitro and in vivo design to accelerate progress toward first-in-human trials.

The post AviadoBio broadens vMiX gene silencing licence with King’s College London appeared first on Pharmaceutical Business review.

The company’s board of directors unanimously approved the acquisition, which remains subject to customary closing conditions, including shareholder and regulatory approvals. Completion of the transaction is expected in the fourth quarter of 2026.

Altaris plans to combine Simulations Plus with Chemical Computing Group (CCG), a company in its portfolio. CCG provides advanced molecular design software for clients in the pharmaceutical, chemical and materials sectors.

The combination aims to build a more comprehensive biosimulation platform for drug discovery and development, supporting customers throughout the entire research and development life cycle.

Following the closing of the acquisition, Simulations Plus is expected to become a privately held subsidiary of Altaris. The company’s main office will remain in Research Triangle Park, North Carolina.

Once the process is finalised, Simulations Plus’ shares will be delisted from the Nasdaq Stock Exchange.

Simulations Plus develops model-informed and AI-driven drug development software.

Its platforms, including GastroPlus, the Monolix Suite, ADMET Predictor, and the quantitative systems pharmacology/quantitative systems toxicology (QSP/QST) platform, are widely used by large pharmaceutical companies, contract research organisations, and regulatory agencies.

CCG’s flagship product, the molecular operating environment, has been adopted in the global biopharma sector for more than 30 years.

Simulations Plus CEO Shawn O’Connor said: “The life sciences industry is at an inflexion point, as software and services are rapidly evolving toward integrated, AI-driven platforms, cloud-based infrastructure, and more predictable, subscription-based business models.

“This transaction provides immediate and certain value to Simulations Plus stockholders, and we believe the transaction will better position us to serve our customers and accelerate innovation across product offerings.”

Financial and legal advisers for the transaction include Morgan Stanley and Procopio Cory Hargreaves & Savitch for Simulations Plus, alongside Truist Securities; JP Morgan Securities; Bass, Berry & Sims; and Kirkland & Ellis for Altaris.

In March 2026, Simulations Plus announced strategic partnership programmes with three pharmaceutical businesses to advance AI-enabled modelling in drug development.

The post Altaris to acquire Simulations Plus in $375m all-cash deal appeared first on Pharmaceutical Business review.

Industries often grow fastest before regulation catches up. Fintech experienced it. The gig economy experienced it. Consumer technology platforms experienced it. India’s aesthetics industry is now experiencing its own version of the same story.

The recent CDSCO clarification that injectable cosmetic products should be regulated under the drug framework represents more than a compliance update. It marks the transition of a rapidly expanding industry from regulatory ambiguity toward regulatory maturity.

Injectable aesthetic procedures occupied a grey zone for years. Products capable of producing physiological effects were often marketed and distributed through pathways that did not always reflect their risk profile. As clinics, salons, wellness centres and aesthetic providers expanded access to these treatments, the regulatory framework struggled to keep pace with market evolution.

The challenge is not unique. Similar patterns have emerged across multiple sectors. In fintech, digital payment providers initially benefited from a relatively light-touch environment that encouraged innovation and adoption. As the sector expanded and consumer dependence increased, regulators introduced stricter requirements around licensing, governance, cybersecurity and consumer protection.

The gig economy followed a comparable trajectory. Platform businesses grew rapidly before governments began addressing questions around worker protections, accountability and employment relationships. Consumer technology companies similarly encountered increasing scrutiny regarding data protection content moderation and digital governance as their societal impact expanded.

All of the examples above suggest that in each case, regulation followed scale.

The aesthetics industry appears to be approaching a similar turning point. Injectable procedures are no longer niche medical offerings confined to specialist clinical settings. Social media marketing, influencer endorsements and growing consumer acceptance have transformed them into mainstream services. As volumes increase, so do questions around product authenticity, practitioner qualifications, adverse-event management and consumer protection.

The CDSCO clarification addresses these concerns by aligning regulatory treatment with product risk. If a product enters the body and influences physiological processes, it is increasingly difficult to justify oversight equivalent to that of externally applied cosmetics.

The transition presents both challenges and opportunities for healthcare providers. Compliance expectations are likely to increase across sourcing, storage, documentation, practitioner credentialing and patient safety processes. Businesses that previously relied on informal procurement channels or inconsistent operational controls may face significant adjustments.

However, experience from other sectors suggests that regulatory formalisation often strengthens markets rather than weakens them. Fintech’s growth did not stop after increased regulation. Digital payments became more trusted. Consumer technology platforms continued expanding despite heightened governance obligations. In many cases, stronger oversight improved consumer confidence and accelerated long-term adoption. The same outcome is possible for aesthetic medicine.

Providers that embrace compliance early are likely to benefit from greater consumer trust and reduced operational risk. Clear sourcing records, qualified practitioners, documented protocols and transparent patient communication may increasingly become market differentiators rather than regulatory burdens.

Manufacturers face a similar reality. Product traceability, evidence generation, quality systems, and post-market monitoring will assume greater importance. While compliance costs may rise, so too may confidence in product quality and safety.

The most successful businesses during regulatory transitions are rarely those that resist change. They are the ones who recognise formalisation as an inevitable stage of industry evolution and adapt before enforcement compels them to do so.

The practical priorities are straightforward. Providers should review procurement practices, verify product authenticity, strengthen inventory controls and ensure practitioner qualifications are adequately documented. Manufacturers should reassess product classifications, evaluate regulatory obligations and prepare for higher standards of oversight. Marketers should revisit messaging that portrays injectable procedures as routine beauty treatments without adequately communicating associated risks.

The aesthetics industry is unlikely to slow down. Consumer demand continues to grow, technology continues to advance and new products continue to enter the market. The question is no longer whether the industry will be regulated more closely but how effectively businesses adapt to that reality.

The CDSCO clarification is the beginning of a broader shift toward accountability and risk-based regulation. If lessons from fintech, the gig economy and consumer technology are any indication, the businesses that adapt early will be the ones best positioned to thrive in the next phase of industry growth.

The Government of Karnataka convened the 64th meeting of the Vision Group on Biotechnology (VGBT) to review the State’s biotechnology ecosystem and discuss strategic priorities for biotechnology, biomanufacturing, health innovation and the bioeconomy.

The Vision Group is chaired by Dr Kiran Mazumdar-Shaw, Executive Chairperson and Founder, Biocon Ltd. The group includes leaders from industry, academia, healthcare and research institutions. The meeting was attended by Dr N. Manjula, IAS, Secretary to the Government, Department of Electronics, IT, Biotechnology and Science & Technology, Government of Karnataka, and members including Dr G Padmanaban, Dr Devi Shetty, Dr Taslimarif Saiyed, Dr Vishal Rao and Dr Murali Ramachandra.

Members reviewed biotechnology initiatives in the State and discussed measures related to innovation, commercialisation, advanced manufacturing, talent development and investment in the biotechnology sector. The Vision Group noted the work of qpiAI and the role of artificial intelligence and quantum technologies in life sciences. Members discussed the use of artificial intelligence in research, diagnostics, drug discovery, genomics, precision medicine and healthcare applications.

Dr Kiran Mazumdar-Shaw, Chairperson, Vision Group on Biotechnology, said: “Karnataka has built one of India’s strongest biotechnology ecosystems, supported by world-class research institutions, industry leadership and a vibrant startup community. As we enter the next phase of growth, we must strengthen mechanisms that support translational research, commercialization and scale-up. Biotechnology startups require patient capital, strong industry partnerships and long-term support. Karnataka should explore dedicated biotechnology investment mechanisms while embedding artificial intelligence across the biotechnology value chain to unlock new opportunities in drug discovery, diagnostics, precision medicine and biomanufacturing.”

Dr Mazumdar-Shaw also stated the need to strengthen pathways for biotechnology startups to access growth capital and scale globally, and to reinforce Karnataka’s position in biotechnology innovation and entrepreneurship.

Dr N Manjula, IAS, Secretary, Department of Electronics, IT, Biotechnology and Science & Technology, Government of Karnataka, said: “Karnataka’s biotechnology leadership has been built on a strong foundation of talent, innovation and collaboration. The Government remains committed to strengthening the entire biotechnology value chain—from research and innovation to entrepreneurship, manufacturing and workforce development. Our focus is on creating an enabling ecosystem that supports innovation, attracts investment and develops a future-ready workforce.”

Members discussed strengthening Karnataka’s biotechnology innovation and financing ecosystem, including a State-level framework to support biotechnology enterprises across stages of growth through funding, mentoring, regulatory guidance and commercialisation support. The Vision Group also discussed engagement with venture capital firms, strategic investors and industry stakeholders to improve access to growth capital for biotechnology startups.

The group discussed Bengaluru Tech Summit 2026 as a platform to showcase biotechnology companies through investor engagement and startup-investor connect initiatives.

Members identified focus areas for the coming year, including AI-enabled biotechnology applications in drug discovery, diagnostics, genomics, precision medicine, synthetic biology and healthcare innovation. The group also discussed expansion of biomanufacturing infrastructure, funding mechanisms for startups, regulatory and commercialisation support, marine biotechnology and coastal bioeconomy initiatives including seaweed cultivation, bioenergy and synthetic biology.

Discussions also covered innovation infrastructure development, biotechnology institution roadmaps, startup support mechanisms and technology commercialisation pathways. The Vision Group also discussed biotechnology skilling initiatives and industry-oriented training programmes.

Prof G Padmanaban highlighted the importance of biomanufacturing for biotechnology growth and export competitiveness and the need for investments and ecosystem support.

The Vision Group stated that Karnataka’s biotechnology growth will be driven by biomanufacturing capabilities, access to innovation capital and integration of artificial intelligence across the life sciences ecosystem.

The meeting reaffirmed Karnataka’s focus on building a biotechnology ecosystem for scientific development, economic growth and societal impact.

Glenmark Pharmaceuticals., USA (Glenmark) has announced the launch of Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL) Single-Dose Vial.

Glenmark stated that its Methylene Blue Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug, ProvayBlue Injection, 50 mg/10 mL (5 mg/mL), of Provepharm SAS [NDA 204630].

According to IQVIA sales data for the 12-month period ending April 2026, the ProvayBlue Injection, 50 mg/10 mL (5 mg/mL) market achieved annual sales of approximately $19.0 million.

Marc Kikuchi, President & Business Head, North America, said, “The launch of Methylene Blue Injection USP reflects Glenmark’s ongoing commitment to expanding access to quality, affordable medicines for healthcare institutions and the patients they serve. This addition further strengthens our institutional portfolio and reinforces our focus on delivering reliable treatment options across the U.S. market.”

It extends access to a treatment option previously confined to injection-based administration.

The newly authorised EURneffy 1mg can be used for emergency management of severe allergic reactions caused by insect stings, food, medicines, idiopathic or exercise-induced anaphylaxis in this paediatric group.

This follows the earlier MHRA approval of EURneffy 2mg for adults and children weighing 30kg or more in the UK.

Anaphylaxis is a rapidly progressing and potentially life-threatening allergic reaction that requires immediate treatment.

ALK Europe commercial operations EVP Flora Beiche-Scholz said: “This approval reflects our continued commitment to expanding treatment options for children with severe allergies. For decades, children at risk of anaphylaxis have been limited to injectable adrenaline — yet fear of needles, hesitancy to act and incorrect administration mean adrenaline is too often not carried or used in time.

“EURneffy 1mg aims to address these barriers, offering a needle-free adrenaline solution with the potential to transform the lives of those living with, or caring for, children with severe allergies. This approval brings us closer to ensuring every family affected by severe allergies has a treatment they will actually carry and use.”

Clinical study data show EURneffy delivers adrenaline rapidly and demonstrates a comparable pharmacological response to traditional auto-injectors in both single and repeat doses.

The most commonly reported adverse reactions among children in the approved weight range were nasal congestion (19%), upper respiratory tract congestion (14.3%), and others such as dry throat, nasal dryness, and paraesthesia (each 9.5%).

No clinically relevant differences in safety were found between paediatric and adult populations.

EURneffy offers a portable, needle-free alternative to traditional adrenaline delivery, requires no special storage, and has a shelf life of 24 months for the 1mg dose.

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In the US, the ODD offers incentives such as tax credits for clinical testing, exemption from certain FDA application fees, and seven years of marketing exclusivity if approved.

In the EU, benefits include protocol support, reduced regulatory fees, and up to ten years of exclusivity upon approval.

Previously, the FDA also granted breakthrough therapy designation to alixorexton for narcolepsy type 1 (NT1).

The therapy is under evaluation in Phase III Brilliance Studies for NT1 and NT2 in adults, as well as in the Phase II Vibrance-3 study for idiopathic hypersomnia.

Narcolepsy, a rare and chronic neurological disorder, disrupts the regulation of the sleep-wake cycle.

Its primary symptom is excessive daytime sleepiness, and it is categorised by type based on the presence of loss of orexin neurons and cataplexy.

IH is another rare sleep disorder marked by pronounced daytime sleepiness despite adequate nighttime sleep. Symptoms include sleep inertia, fatigue, and cognitive issues.

Alixorexton (previously ALKS 2680) targets the orexin system, considered central to the regulation of wakefulness, for potential benefit in hypersomnolence disorders regardless of orexin deficiency.

Alkermes chief medical officer Craig Hopkinson said: “These orphan drug designations represent important milestones for the alixorexton programme and underscore its potential, if approved, to advance care for the narcolepsy and idiopathic hypersomnia patient communities.

“Alixorexton’s Phase II clinical trial results in NT1 and NT2 underscore its potential to become a differentiated treatment option. We look forward to continuing our momentum in the alixorexton development programme as we enrol the Phase III Brilliance Studies and work to complete the Vibrance-3 Phase II study in IH this year.”

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ILAMED has expanded its international presence with the launch of centres in Nairobi, Kenya; Addis Ababa, Ethiopia; and Bangkok, Thailand. The institute is also preparing to launch its next overseas centre in Cairo, Egypt, in September 2026.

ILAMED commenced its international expansion in February 2026 with the launch of its Nairobi centre, followed by Addis Ababa in May 2026. The institute established its presence in Bangkok in June 2026, extending its reach into Southeast Asia. According to the institute, the Cairo centre will further strengthen its presence across Africa.

The expansion is part of ILAMED’s plans to build a global network for aesthetic medicine, cosmetology and healthcare training across emerging markets, while addressing the demand for skilled professionals and healthcare education.

Dr Ajay Rana, Founder and Director, ILAMED, said, “Our international expansion reflects ILAMED’s commitment to making world-class aesthetic medicine education and training accessible to healthcare professionals across the globe. Africa, in particular, presents tremendous opportunities due to its growing healthcare infrastructure, increasing demand for specialized medical services, and rising interest in aesthetic medicine. The successful response we have received in Nairobi and Addis Ababa has reinforced our confidence in the region’s potential. With Bangkok now operational and Cairo on the horizon, we are steadily building a strong international ecosystem that empowers medical professionals with globally recognized education, advanced clinical skills, and industry-leading expertise.”

According to ILAMED, Africa is a market for healthcare and medical education, driven by urbanisation, healthcare investments, awareness of aesthetic procedures and the need for specialised training. Through its presence in key African cities, the institute aims to provide internationally accredited programmes, hands-on clinical exposure and access to global practices in aesthetic medicine and cosmetology.

The institute stated that its expansion into Bangkok supports its plans to establish a presence across international healthcare hubs, facilitating cross-border collaborations, knowledge exchange, faculty development and networking opportunities for medical professionals.

ILAMED stated that it is evaluating additional international markets as part of its plans to advance medical education globally while contributing to India’s role in healthcare innovation, medical expertise and professional training.

The institute offers programmes in cosmetology, aesthetic medicine, trichology, hair transplantation, anti-ageing medicine, lasers and cosmetic procedures. ILAMED stated that it continues to focus on innovation, academic standards, practical training and international standards as it expands its international presence.

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If the research is successful, Simcere will have the option to in-license the molecule and secure all global rights to the resulting product.

The study will involve collaboration with Stanford Medicine chemical biology researchers, led jointly by Stanford Medicine Accelerator director and chemistry and chemical engineering professor Chaitan Khosla, and Stanford Medicine chemistry professor and fibrosis-related targets specialist Cui Bianxiao.

IPF is a chronic, progressive lung disease with no known cause, marked by the development of fibrosis in the lung interstitium.

This leads to increased stiffness and reduced elasticity in lung tissue, progressing to respiratory failure.

Simcere Pharmaceutical stated that current medical options do not fully reverse pulmonary fibrosis, and the median survival time following diagnosis is about three years. The five-year survival rate is estimated at 20%-40%.

Simcere Pharmaceutical chief investment officer Zhou Gaobo said: “This marks the second first-in-class original project worldwide in collaboration between Simcere and Stanford Medicine.

“This ongoing collaboration reflects Simcere’s active steps toward Innovation 2.0 and fulfils its corporate mission (‘For patients, for life’). We look forward to jointly developing more innovative products to benefit patients.”

Professor Khosla commented: “Highly targeted therapies for idiopathic pulmonary fibrosis have long been an urgent unmet clinical need. We are pleased to work with Simcere to advance the translation of chemical biology breakthroughs together.”

In June 2025, NextCure entered a strategic partnership with Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, to develop SIM0505, a new antibody-drug conjugate targeting cadherin-6 or K-cadherin (CDH6) for treating solid tumours.

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This marks the initial approval for Welireg in earlier-stage ccRCC and the first approved combinations featuring programmed cell death protein 1 (PD-1) and hypoxia-inducible factor 2-alpha (HIF-2α) inhibitors.

The approvals are based on data from the pivotal Phase III LITESPARK-022 trial, which enrolled 1,841 patients.

The study showed that Keytruda and Welireg improved the primary endpoint of disease-free survival (DFS) by reducing the risk of recurrence, metastasis, or death by 28% in patients at intermediate-high or high risk, following nephrectomy, compared to Keytruda plus placebo.

The estimated 24-month DFS rate was 81% with Keytruda plus Welireg and 74% with Keytruda plus placebo. Median DFS was not reached in either group at the time of analysis.

Overall survival data were not mature. The effectiveness of Keytruda Qlex was determined using evidence from controlled studies with Keytruda, along with data from MK-3475A-D77, comparing the pharmacokinetic, efficacy, and safety profiles.

Welireg prescribing information includes a boxed warning about embryo-foetal risk and requires verified pregnancy status before initiation.

Patients are to be counselled regarding the risks and to avoid hormonal contraception, which may be rendered ineffective. Welireg can cause severe anaemia and hypoxia, requiring careful monitoring and potentially intervention.

Keytruda Qlex is contraindicated in patients with hypersensitivity to berahyaluronidase alfa, hyaluronidase, or any excipients.

Both Keytruda and Keytruda Qlex are associated with the risk of severe immune-mediated reactions and other serious complications, including transplant rejections, infusion reactions, and increased mortality in certain patient groups.

Merck research laboratories global clinical development vice-president Dr Catherine Pietanza said: “Reflecting on my own experience as a clinical oncologist, I know the significant impact that improved disease-free survival can have on the lives of patients.

“These approvals demonstrate Merck’s commitment to pursuing innovative treatment options that may help these patients experience longer periods without disease.”

In April 2026, MSD and Google Cloud formed a multi-year partnership investing up to $1bn to advance agentic AI enterprise transformation.

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Novartis India has announced the launch of Pluvicto (lutetium (177Lu) vipivotide tetraxetan), the country’s first regulatory authority approved radioligand therapy for eligible patients with Prostate-Specific Membrane Antigen (PSMA)-positive prostate cancer.

Pluvicto is designed to target prostate cancer cells while minimising exposure to healthy tissues. The therapy introduces a treatment approach for metastatic prostate cancer.

The company stated that prostate cancer is among the top three cancers affecting urban men in India, with nearly 250,000 cases every year. Approximately 50 per cent of diagnosed patients present at a metastatic stage, where treatment becomes more complex due to prognosis, treatment-related side effects and challenges in treatment sequencing.

Judith Love, Region Head Asia Pacific Middle East Africa, Novartis, said, “India is a priority market for Novartis, with growing momentum in precision oncology and advanced cancer care. The introduction of Pluvicto marks a meaningful step forward – bringing globally approved innovation closer to patients who need more targeted treatment options. What makes this launch especially impactful is not just the science, but the opportunity to expand access through India’s growing nuclear medicine infrastructure. We remain committed to enabling access to next-generation treatments, and I’m excited about the difference Pluvicto can make for patients in India.”

Amitabh Dube, Country President and Managing Director, Novartis India, said, “In India, a large proportion of prostate cancer patients continue to be diagnosed only after the disease has progressed to a metastatic stage, limiting treatment options and impacting quality of life. With the launch of Pluvicto, we are bringing a globally recognized radioligand therapy platform to India at a time when the need for precision oncology solutions is increasing rapidly. Beyond the therapy itself, our focus is on building long-term partnerships with hospitals and healthcare stakeholders to help strengthen access pathways, multidisciplinary collaboration, and readiness for the future of nuclear medicine in India.”

Novartis stated that India’s nuclear medicine ecosystem includes more than 250 nuclear medicine centres across the country. The company plans to collaborate with healthcare institutions, oncologists, nuclear medicine specialists and hospital partners to support treatment readiness and multidisciplinary care pathways for eligible patients.

Pluvicto will be made available through select hospitals and nuclear medicine centres across India as part of Novartis’ partnership-led approach for bringing radioligand therapies to India. The company is also working with healthcare stakeholders to strengthen awareness and infrastructure preparedness for precision oncology care.

Pluvicto (lutetium (177Lu) vipivotide tetraxetan) is an intravenous radioligand therapy that combines a targeting compound with a therapeutic radionuclide.

Following administration into the bloodstream, Pluvicto binds to Prostate Specific Membrane Antigen (PSMA)-expressing target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death. The therapy delivers targeted radiation to cancer cells while minimising the impact on healthy tissue.

According to Novartis, Pluvicto is the only regulatory authority approved finished formulation for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The therapy is imported from Spain and Italy from GMP facilities. In the Phase III clinical study, Pluvicto demonstrated a reduction in the risk of disease progression or death and an improvement in radiographic progression-free survival compared to standard approaches in eligible patients, along with a consistent and manageable safety profile. The study also reported improvements in patient-reported quality-of-life measures in defined treatment settings.

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Ipca Laboratories (Ipca), Mumbai, and Bhami’s Research Laboratory (BRL) have announced a global licensing agreement for BRL’s proprietary high-concentration subcutaneous biologics delivery platform.

Under the agreement, Ipca will gain access to BRL’s platform for the development and commercialisation of multiple monoclonal antibody products targeting oncology and inflammatory diseases.

Pranay Godha, Managing Director and Chief Executive Officer, Ipca Laboratories, said, “By pairing Ipca’s established science with BRL’s Novel Formulation Platform, we’re accelerating developing affordable biologics for people battling cancer and autoimmune disease worldwide.”

Surya Pai, Chief Executive Officer and Co-Founder, BRL, said, “We are delighted to be expanding the reach of our novel, proprietary, patented subcutaneous protein delivery platform technology through this exciting partnership with Ipca to develop differentiated biologics for the global market. This strategic partnership is designed to make patient care convenient, affordable and safe.”

Akhil Shah, Director and Chief Executive Officer, WeTranslate, said, “WeTranslate was founded with a simple belief—that world-class innovation deserves worldclass commercialization pathways. BRL has built a differentiated formulation technology platform, and Ipca brings the scale, expertise, and global reach required to unlock its full potential. We are delighted to support this collaboration and look forward to seeing its impact on the future of biologic drug delivery.”

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 Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.05 per cent.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.05 per cent, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. Refer label for a detailed indication.

Tretinoin Cream USP, 0.05 per cent, has an estimated market size of US$ 76 million for twelve months ending March 2026 according to IQVIA.

Alembic has a cumulative total of 242 ANDA approvals (222 final approvals and 20 tentative approvals) from USFDA.

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Skincare consumers today are much more knowledgeable and savvier about skincare products than ever before. Ten years ago, consumers would be drawn to skincare products through packaging, celebrities endorsing a brand, smell of fragrances, or promises of “instant glow.” Now, however, there seems to be a major shift occurring within the realm of consumers and skincare products. Today’s consumers are becoming very well-informed about skincare products, reading their labels, understanding the active ingredients, comparing the formulations of the various products, and determining if the product is really appropriate for their skin type and issues.

This is of utmost importance to the field of cosmeceuticals as many cosmeceutical formulas have become more complex in recent times, offering not only cosmetic improvements but active ingredients which help with issues like acne, hyperpigmentation, skin barrier repair, collagen production, hydration, and even visible signs of aging. In short, it is no longer an option for a skincare brand in the cosmeceutical field to hide its product formula it has now become mandatory.

Rise of ingredient education and consumer uncertainty

As a cosmetic physician, I have seen this transformation in my consulting practice. Today, patients know what niacinamide, retinoids, peptides, ceramides, hyaluronic acid, tranexamic acid, exfoliating acids, and growth factors are. It is good to see people being interested in skincare and learning more about their skin. However, it also created some confusions. The skincare industry offers numerous products that are based on scientific terms and contain exaggerated claims about efficacy or quality. Words “clinical grade,” “dermatologically tested,” “clean beauty,” “anti-ageing,” or “barrier repair” can be used by companies in order to convince customers that they buy a high-quality product, but sometimes consumers cannot really understand what they are buying when it comes to the actual composition of these products.

It is crucial to explain a product since skincare is highly personalised. While a product may have a significant effect for one person, it might be irritating and cause other side effects in another one. In addition, those who have acne, rosacea, pigmentation issues, sensitive skin, post-procedure problems, or impaired skin barrier need a special care, which can be impossible to provide if products are not explained properly to clients.

Social media, spreading mistruths, and the wrong use of active ingredients

One of the most pressing issues of today’s world is the blind consumption of active ingredients driven by social media. While social media has certainly made skincare education easily available to many, it has also facilitated misinformation. It has become a general belief that the higher percentage of an active ingredient will always produce greater effects. However, this assumption is wrong – a higher percentage alone does not guarantee efficacy if a formula is unstable, irritant, or simply not compatible with your skin type. In addition to ingredients, other aspects such as delivery systems, pH levels, ingredient compatibility, tolerability, formulation science and evidence are also critical for efficacy.

What is expected from companies?

This is the point at which brands and manufacturers play a pivotal role. Ingredient education must go further than disclosing the name of an ingredient at the back of a package. Information should include what a particular ingredient should be doing, who it suits best, the proper frequency of application, potential combinations that should be avoided, and when to consult a dermatologist before applying the product. There are certain ingredients that should receive extra care due to their high risk of causing various side effects.

Transparency is also vital for trust building purposes. Currently, there is a new era of credibility taking place within the beauty industry, whereby consumers are becoming wary of marketing gimmicks, influencer-promoted products, and trends. Therefore, brands whose communications around the performance capabilities of their formulations are realistic stand a better chance at developing consumer trust. While promises can help grab the attention of the consumers, having unrealistic promises only leaves the customers disappointed and without any confidence in the company. There is yet another factor that must be discussed; safety.

Beauty product safety and scientific communication

As cosmeceutical formulations continue to develop and improve, there becomes no distinction left between cosmetics and skincare products anymore. While most of these cosmeceutical formulations may be safe when used as intended, they must still be formulated responsibly and positioned correctly in order not to create unnecessary panic amongst consumers. Claims relating to issues such as acne treatment, pigmentation removal, collagen production, hair growth, barrier protection, or anti-ageing need to be handled with care.

When it comes to consumers in India, the need for ingredient transparency is further amplified. Indian skin naturally tends to tan more, develop post-inflammatory hyperpigmentation or melasma and react to aggressive skin care treatments or misused products. At the same time, trends from overseas markets do not always account for Indian climate, pollution, lifestyles or behavior of Indian skin. A skin care formula which will work in one market might have a different effect on Indian skin. That is why there is an added importance of having regionally-relevant skin care education and transparent communications.

How transparence facilitates effective professional guidance

Ingredient transparency further benefits doctor-patient discussions about the products being used. Bringing skincare products to a consultation, a dermatologist or aesthetician can easily see what active ingredients or allergens could be in the product, potentially interfering with the current treatment regimen of the patient. For example, in a case of someone using cosmetic treatments like lasers, peels, injections, skin boosting or regenerative treatments, pre and post care are vital for results.

The evolution of cosmeceuticals and consumer reassurance

Cosmeceutical products of the future will belong to those brands that recognise the consumer intelligence. Nowadays, customers are tired of untruthful and exaggerated statements. People seek for clear information, scientific data, and safe products. Moreover, people want to learn why this or that ingredient is added to products, its function, and whether it actually fits in their skin care routine.

However, at the same time, educating consumers on ingredients does not mean scaring them. Every chemical-sounding ingredient is not necessarily bad, and every natural one is not necessarily beneficial. The same goes for trending active ingredients – they are not always necessary. The use of cosmeceuticals should be reasonable; there is no need to apply as many products and ingredients as possible. Skincare routines should consist of the most needed ingredients.

Thus, when further developing the industry, it is also crucial to ensure ethical communication and educate customers regarding the products they purchase. The cosmeceutical industry will need to gradually shift from trendiness to scientific truth. Therefore, the transparency of ingredients means much more than the contents of the bottle. Consumers trust ingredients and the brand which puts them in products. Moreover, the responsibility of the industry should be mentioned here.

The post Why ingredient transparency matters more than ever in cosmeceuticals appeared first on Express Pharma.

People have died in India’s aesthetic clinics. Not in rare surgical catastrophes, but in routine cosmetic procedures performed by people who should never have held the syringe. The Indian Association of Dermatologists, Venereologists and Leprologists has documented at least five deaths, along with cases of disfigurement and lasting psychological trauma, and has formally asked the government to intervene. That intervention has not come. As a practising dermatologist, I am writing this not to explain the Cosmetics Rules, 2020 to my colleagues, but to ask our regulators a more uncomfortable question. The framework exists on paper. Why does so little of it exist on the ground?

A market regulated in theory

On paper, India’s framework looks respectable. The Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020 give CDSCO authority over imports, give State Licensing Authorities control over manufacturing, and give the Bureau of Indian Standards the mandate to define what is safe to put on human skin. Imported cosmetics must be registered on the SUGAM portal before sale, with registration certificates valid for five years. Products making therapeutic claims must clear the far stricter drug pathway. The revised IS 4707 standards of 2025 tightened the lists of restricted substances and permitted preservatives further.

In practice, walk through any metro market or scroll through any shopping app. Unregistered imported cosmeceuticals are sold openly. In May 2025, a single enforcement action by Gujarat’s FDCA seized counterfeit cosmetics worth Rs. 71.5 lakh, much of it marketed on social media without licences or labelling. That seizure was reported as a success. I read it as an indictment. If one state raid uncovers that much in one sweep, the steady state of the market is not compliance. It is impunity punctuated by occasional raids.

The grey zone the regulator refuses to close

The most consequential gap is definitional. “Cosmeceutical”, the category in which most of modern dermatology-adjacent retail actually operates, has no legal status in India. A product is either a cosmetic or a drug, and the classification turns almost entirely on the claims a marketer chooses to print. The result is a market that has learned to write its way around the law. Brands make quasi-therapeutic promises in advertising, retreat to cosmetic language on the label, and face essentially no consequence for the distance between the two.

This ambiguity does not just enable mischief by sellers. It punishes honest clinicians, who restrict themselves to defensible claims while competing against brands and clinics that do not. A regulatory regime that disadvantages the compliant is not a neutral regime. It is an active distortion, and only CDSCO can correct it.

Procedures without a referee

The injectable and device economy is where the stakes stop being commercial and become bodily. Botulinum toxin, dermal fillers, glutathione infusions and energy-based devices are now marketed to young consumers through influencer reels and subscription packages, frequently administered in premises with no dermatologist, no anaesthetist, no emergency protocol and no meaningful inspection history. India’s aesthetic medicine market was estimated at around two billion dollars in 2024 and is projected to more than triple by 2033. A sector of that size, performing invasive procedures, is operating without a dedicated referee.

And when something goes wrong, India has no system to even know. There is no structured cosmetovigilance framework. Adverse reactions to cosmetic products are common in dermatological practice, yet patients have no designated reporting channel, and dermatologists, the clinicians who actually see these complications, are not integrated into any monitoring system. Compare this with the United States, where MoCRA now mandates facility registration, ingredient disclosure and adverse-event reporting within 15 days. Indian law requires none of this proactively.

What we are asking for

So let me be specific, because vague calls for “stronger regulation” are how this issue has been managed into stasis for a decade. First, define the cosmeceutical category in law, with claim tiers linked to evidence, so that the line between a cosmetic and a drug is decided by the regulator and not by a copywriter. Second, build a national cosmetovigilance system with mandatory adverse-event reporting and dermatologists formally embedded as sentinel reporters. Third, restrict injectable and energy-based procedures to registered medical practitioners with defined qualifications, and make premises licensing for aesthetic procedures a legal requirement, not a market courtesy. Fourth, move enforcement from sporadic raids to systematic post-market surveillance, including of e-commerce and social media sellers, where the worst offenders now live. The Compounding of Offences Rules notified in April 2025 show the machinery for accountability is being assembled. It must now be pointed at the right targets.

Our side of the bargain

None of this absolves my own profession. Dermatologists who lend their names to products they have not scrutinised, who dispense imported ranges without checking registration certificates, or who let their clinic marketing drift into therapeutic claims for cosmetic products are part of the problem we are asking the state to solve. Clean claims, verified supply chains and documented procedures are obligations we owe our patients regardless of how slowly the law catches up.

But individual ethics cannot substitute for institutional enforcement. Patients are being injected, infused and resurfaced in a market where the gap between the rulebook and the street has become a business model. CDSCO has the statute, the portal and now the penalty framework. What the public is still waiting for is the will. The deaths the IADVL has counted should be treated as what they are: not unfortunate anomalies, but the predictable output of a regulated industry that is not, in any meaningful sense, being regulated.

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Study results showed that gumokimab delivered rapid and strong efficacy.

At week 12 of the Phase III trial, gumokimab achieved a Psoriasis Area and Severity Index 75 (PASI 75) response rate of 94.6% and a complete skin clearance rate (PASI 100) of 47.7%, compared with 28.6% for other agents in the same class.

Durable results were seen through week 52, with a PASI 75 response rate approaching 100% and a PASI 100 response rate of 68.9%.

The safety data also showed a favourable profile for gumokimab, with incidences of treatment-emergent adverse events, serious adverse events, and infections listed among the lowest seen in similar trials of IL-17 inhibitors.

The therapy’s subcutaneous regimen requires only 17 injections annually, including the loading phase, approximately half the injection burden mandated by other IL-17 inhibitors.

Huashan Hospital, Fudan University professor Xu Jinhua is the principal investigator of the study.

Akeso founder, chairwoman, president and CEO Dr Xia Yu said: “To better address patients’ diverse needs, Akeso has successfully developed and launched ebdarokimab and gumokimab, two therapies targeting distinct pathogenic pathways that complement each other.

“The autoimmune disease field remains one of the largest and fastest-growing areas in innovative drug development. With these two approvals, we have built a strong, differentiated portfolio for psoriasis.”

The NMPA’s Center for Drug Evaluation (CDE) has accepted a supplemental new drug application for gumokimab in active ankylosing spondylitis.

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The FDA is anticipated to make its decision on this regimen by 9 October 2026.

Roche’s submission is supported by data from the Phase III ATOMIC study, which was recently published in The New England Journal of Medicine.

The trial showed that Tecentriq combined with standard folinic acid, fluorouracil and oxaliplatin regimen (FOLFOX6) chemotherapy reduced the risk of recurrence or death by 50% compared with chemotherapy alone for people diagnosed with stage III dMMR colon cancer.

At 36 months, disease-free survival was 86% for Tecentriq and chemotherapy compared to 76% for chemotherapy only. The safety profile aligned with previous studies.

Roche is seeking additional regulatory approvals for the therapy, including from the European Medicines Agency (EMA), to expand access to this immunotherapy-based option for dMMR/MSI-H colon cancer.

The randomised, open-label, multi-centre ATOMIC study enrolled 712 patients.

Tecentriq is a monoclonal antibody that targets the PD-L1 protein on tumour and immune cells.

It has received approval for use in treating multiple difficult-to-treat cancers and is available in both subcutaneous and intravenous forms.

Roche global product development head and chief medical officer Levi Garraway said: “This filing acceptance brings us closer to establishing adjuvant Tecentriq plus chemotherapy as a new standard of care for certain types of early colon cancer.

“The ATOMIC results demonstrate that Tecentriq plus chemotherapy can substantially reduce the risk of disease recurrence or death, helping more patients remain cancer-free following surgery.”

Earlier this month, the FDA accepted priority review of the new drug application for Roche’s investigational oral selective oestrogen receptor degrader, giredestrant, for breast cancer.

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Panelists in this video:
+ Mr Suveer Shrivastava, Global Pharma Compliance Expert (Moderator)
+ Mr Amit Malviya, VP-Quality Assurance, Zest Pharma
+ Mr Mahanand Thakur, VP-Operations, McW Healthcare
+ Ms Shilpy Singh, GM & Head-Project Management, Piramal Pharma
+ Mr Vikalp Nagori, Associate Director – Formulation Technology Transfer, Cipla

Key Highlights:
[1] The future of Indian pharma lies beyond generics — in innovation, biosimilars, peptides, and globally competitive drug development driven by skill, collaboration and continuous research.

[2] Innovation must be purposeful and patient-focused. Proof of concept is critical to ensure innovation addresses real and underserved healthcare needs.

[3] Regulatory support from regulatory bodies like CDSCO is vital to create an ecosystem that encourages entrepreneurship, innovation and talent retention.

[4] AI and automation are no longer optional for pharma. They are essential to build transparency, improve compliance, reduce manual dependency, and prepare the industry for the future.

[5] Ethical practices, accountability, quality culture, and patient-centricity will define India’s long-term credibility and global reputation in pharma.

[6] A proactive approach to innovation, capability building and future-ready manufacturing will determine India’s leadership in the global pharma landscape.

The post India Pharma 2035: The next global leadership story appeared first on Express Pharma.

In this video:
Mr Murali Krishna Veeramallu, Head – Industrial Division, Smart Labtech

Topic: Smart industrial weighing solutions

Key Takeaways:
[1] Smart Labtech has evolved into a strong ‘Make in India’ lab and weighing solutions manufacturer with 1000+ installations.

[2] Smart Labtech is driving Industry 4.0-ready pharma manufacturing with smart, customisable, compliance-focused systems.

[3] New-age offerings from the company include moisture analyzers, analytical balances, dispensing systems, and 21 CFR Part 11-compliant solutions.

The post Mr Murali Krishna Veeramallu, Head – Industrial Division, Smart Labtech appeared first on Express Pharma.

In this video:
Mr Akil Kadiyavala, GM – Technical Services, Dhara Lifescience

Topic: Faster coating technology advantage

Key Takeaways:
[1] Dhara Lifescience’s product portfolio includes coating technologies that can cut pharma coating process time by up to 50 per cent.

[2] Its offerings like Readycoat HS and Readycoat EZE enable faster processing, better uniformity and improved efficiency for pharma manufacturers.

[3] The company combines advanced polymer science, global certifications and strong R&D to deliver high-performance coating solutions.

The post Mr Akil Kadiyavala, GM – Technical Services, Dhara Lifescience appeared first on Express Pharma.

In this video:
Mr Ranjit Menon, Site Head – Indore – Manufacturing, Cipla

Topic: Quality as strategy: Winning trust in global markets

Key Takeaways:
[1] Quality is no longer just compliance. It is a strategic leadership function driving business success.

[2] Patient-centric, risk-based quality systems are shaping the future of pharma manufacturing.

[3] Data integrity and transparent decision-making are critical to regulatory and market confidence

The post Mr Ranjit Menon, Site Head – Indore – Manufacturing, Cipla appeared first on Express Pharma.

In this video:
Mr Vivek Asthana, Head EHS & Sustainability, Symbiotec Pharmalab

Topic: Sustainability as strategy: The next frontier for pharma leaders

Key Takeaways:
[1] ESG is no longer optional for the pharma industry. It is fundamental to survival, credibility and growth.

[2] Today, regulators like Securities and Exchange Board of India are mandating ESG disclosures through BRSR. Global frameworks are tightening.

[3] Investors are evaluating not just financial returns, but how responsibly those returns are generated. Customers and global buyers are increasingly choosing partners who are ethical, transparent and sustainable.

The post Mr Vivek Asthana, Head EHS & Sustainability, Symbiotec Pharmalab appeared first on Express Pharma.

In this video:
Prof (Dr) Neelesh Malviya, Principal, Smriti College of Pharmaceutical Education, Indore

Topic: Academia-industry collaboration for the development of future pharma professionals

Key Takeaways:
[1] Academia–industry collaboration turns research into real-world innovation and commercial impact.

[2] Industry-aligned research accelerates commercialisation, reduces costs and solves practical challenges faster.

[3] Strong collaboration drives skills, entrepreneurship, modernisation and sustainable societal growth.

The post Prof (Dr) Neelesh Malviya, Principal, Smriti College of Pharmaceutical Education, Indore appeared first on Express Pharma.

Panelists in this video:
+ Mr Sanjay Tiwari, Pharma Consultant (Moderator)
+ Mr Dayanand More, Head Site – Operation, Alembic Pharma
+ Mr Nishikant Ghadge, VP (R&D and Manufacturing), Symbiotec Pharma
+ Mr Nitin Tiwari, VP- CQA; (Cluster Head – Indore, Dewas, Ratlam and Wardha), Ipca Laboratories
+ Dr Bipin Chaubey, Head of Site Process & Technology (Dewas), Sun Pharmaceutical Industries
+ Mr Gopinath Santhosh, GM – Supply Chain Management, Felix Generics

Key Highlights:
[1] It is important to marry speed with science. Faster development must never compromise quality or patient safety.

[2] Strong API and KSM capabilities are critical for faster, resilient drug development and supply.

[3] Collaboration between R&D, API manufacturers, regulators and logistics partners speeds innovation.

[4] AI and digital tools are reshaping drug discovery, trials and regulatory pathways, making the drug development processes not just faster but also more efficient.

[5] Integrated and robust supply chains with end to end visibility can reduce delays from molecule to market.

[6] From development to commercialisation, process understanding is the key to consistent quality and successful scale-up.

[7] The journey from molecule to market is complex, but strong analytical understanding and process control make commercialisation possible.

[8] A product can only reach the market faster when quality, documentation, stability, and regulatory readiness are built into every stage of development.

The post Panel Discussion: From molecule to market faster: Rethinking drug development appeared first on Express Pharma.

Panelists in this video:
+ Dr Vipin Saxena, Director, Vishwa Life Sciences (Moderator)
+ Mr Paresh Chawla, MD, Alpa Laboratories
+ Mr Amit Chawla, Director, McW Healthcare
+ Mr Tapan Das, Sr GM – Quality, Sun Pharmaceuticals Industries
+ Mr Mahendra Kumar Sahu, GM, Sun Pharmaceutical industries
+ Mr Nikhil Sahu, Sr Group Leader, Head – Packaging Development, Knovea Pharmaceuticals
+ Mr Praveen Jindal, Deputy Chief Manger, Piramal Pharma (Pithampur)

Key Highlights:
[1] Madhya Pradesh is creating an industry-friendly ecosystems for pharma manufacturing through subsidies, proactive governance and strong infrastructure support.

[2] While policies and incentives are encouraging MSME growth, the real challenge for pharma MSMEs continues to be skilled manpower retention and delayed payment cycles impacting cash flow.

[3] Indore’s next phase of growth will depend on building integrated R&D, testing, and specialised pharma support ecosystems locally rather than relying on other states.

[4] Pharma parks with allied industries can significantly improve productivity, collaboration, and overall industry efficiency.

[5] Stronger industry-academia synergies are essential to build a future-ready pharma talent pool in Indore.

[6] Pharma education needs deeper industry involvement to create professionals who are truly industry ready from day one.

[7] Skilling will define the future of India Pharma Inc. The industry must continuously evolve with new technologies, techniques and materials to stay globally competitive.

The post Indore Rising: Central India’s next manufacturing powerhouse appeared first on Express Pharma.

In this video:
Mr Gajanan Patil, COO, H&H Healthcare and Cosmetics

Topic: CDMO opportunity: India’s next manufacturing advantage

Key Takeaways:
[1] The global pharma industry is shifting from traditional manufacturing to strategic CDMO partnerships driven by cost, speed, innovation and supply chain resilience.

[2] India is positioned to lead the next wave of CDMO growth through cost competitiveness, scientific talent, regulatory credibility and the China+One opportunity.

[3] Indore–Pithampur has the infrastructure, export ecosystem, talent base and logistics advantage to emerge as a major global pharma CDMO hub.

The post Mr Gajanan Patil, COO, H&H Healthcare and Cosmetics appeared first on Express Pharma.

As India’s pharma industry prepares for a future shaped by innovation, AI, sustainability, regulatory transformation, and global competition, one message emerged strongly at the Indore Pharma Summit 2026 — the next phase of India Pharma Inc will not be defined by scale alone, but by how collaboratively the industry evolves.

Held in Indore on 8th May, 2026, the summit brought together pharma leaders, regulators, manufacturing experts, quality professionals, academia, technology providers, and supply chain specialists to discuss the future of Indian pharma across manufacturing, R&D, quality, sustainability, skilling, and global competitiveness. 

The summit commenced with a ceremonial lamp lighting led by Ranjit Menon,Site Head – Indore Manufacturing, Cipla; Mahanand Thakur, VP-Operations, McW Healthcare;Amit Malviya, VP-Quality Assurance, Zest Pharma; Suveer Shrivastava, Global Pharma Compliance Expert; ShilpySingh, GM & Head-ProjectManagement, Piramal Pharma; Ajay Singh Dassundi, Secretary, MP Small andMedium Drugs Manufacturers Association; Vikalp Nagori, Associate Director – Formulation TechnologyTransfer, Cipla; and Rajesh Bhatkal, Vertical Head, Express Pharma 

India Pharma 2035: The next global leadership story 

The opening panel discussion titled ‘India Pharma 2035: The Next Global Leadership Story’, set the tone for the summit by examining how India can transition from a volume-driven pharma economy into a globally respected innovation-led healthcare ecosystem. 

Moderated by Suveer Shrivastava, Global Pharma Compliance Expert, the panel featured Amit Malviya, VP-Quality Assurance, Zest Pharma; Mahanand Thakur, VP-Operations, McW Healthcare; Shilpy Singh, GM & Head-Project Management, Piramal Pharma; and Vikalp Nagori, Associate Director – Formulation Technology Transfer, Cipla. 

One of the strongest themes emerging from the discussion was that India’s pharmaceutical future cannot remain dependent solely on conventional generic manufacturing. While India’s position as the “pharmacy of the world” remains globally significant, panelists argued that the next growth wave would come from innovation-driven areas such as biosimilars, peptides, complex injectables, specialty therapies, and globally competitive drug development. 

The panel emphasised that Indian pharma companies must now move from cost leadership to capability leadership. According to the panelists, innovation itself must become more purposeful and patientcentric. The future of R&D will not be defined simply by the number of products developed, but by whether those innovations address real and underserved healthcare needs.

The panel stressed that proof of concept and patient impact must become central to innovation strategies. Incremental innovation without clear therapeutic value would struggle to remain commercially relevant in increasingly competitive global markets. 

The discussion also highlighted the critical role of regulatory support in building a stronger innovation ecosystem. Panelists noted that agencies such as CDSCO will play an increasingly important role in encouraging entrepreneurship, accelerating approvals, enabling innovation, and retaining scientific talent within India.

Another key focus area was digital transformation. AI and automation emerged repeatedly during the discussion as non-negotiable pillars of the future pharma industry. Panelists agreed that Indian pharma companies can no longer treat digitalisation as an optional operational upgrade. 

Instead, AI-enabled systems, automated manufacturing, digital quality systems, and data-driven compliance frameworks are becoming essential for improving transparency, reducing manual dependency, enhancing operational consistency, and preparing Indian pharma for future regulatory expectations. 

The panel also emphasised that India’s long-term global credibility will depend heavily on ethical practices, accountability, data integrity, quality culture, and patient-centricity. As regulatory scrutiny increases globally, the speakers stressed that trust and compliance will increasingly become strategic business differentiators rather than just regulatory obligations. 

The panel concluded with a broader message that India Pharma Inc must adopt a proactive approach toward innovation, future-ready manufacturing, capability building, and global collaboration if it aims to emerge as a long-term global pharma leader. 

Smart manufacturing gains momentum 

Technology-driven transformation in pharma manufacturing formed another major pillar of the summit. 

In the session on ‘Smart Industrial Weighing Solutions’, Murali Krishna Veeramallu, Head – Industrial Division, Smart Labtech, highlighted how precision systems and digital manufacturing technologies are becoming increasingly critical for modern pharma operations. 

According to Veeramallu, Smart Labtech has evolved into a strong ‘Make in India’ laboratory and industrial weighing solutions manufacturer with more than 1000 installations across pharma and industrial facilities. 

He explained that modern pharma manufacturing now requires far more than standalone instruments. Companies increasingly require integrated, connected, and compliance-focused systems capable of supporting Industry 4.0- ready operations.

The session showcased how smart weighing systems, analytical balances, moisture analyzers, dispensing systems, and digitally connected platforms are helping pharma manufacturers improve traceability, compliance, and operational efficiency. Veeramallu also highlighted the importance of 21 CFR Part 11-compliant systems in ensuring data integrity and audit readiness. 

The broader takeaway from the session was clear: digital manufacturing infrastructure is no longer a future investment for pharma companies. It is becoming a present-day operational necessity.

Faster coating technologies 

Manufacturing productivity and process optimisation remained another major area of discussion during the summit. In the session titled ‘Faster Coating Technology Advantage’, Akil Kadiyavala, GM – Technical Services, Dhara Lifescience, discussed advances in pharma coating technologies aimed at improving manufacturing speed, process consistency, and overall operational efficiency. 

According to Kadiyavala, coating remains one of the most time-intensive stages in oral solid dosage manufacturing. Reducing coating cycle time while maintaining uniformity and quality can significantly improve manufacturing productivity and reduce operational costs. He highlighted Dhara Lifescience’s coating solutions such as Readycoat HS and Readycoat EZE, which can reduce coating process time by up to 50 per cent. 

The session demonstrated how advanced polymer science and formulation engineering are helping manufacturers achieve faster processing, improved coating uniformity, and better batch consistency. Kadiyavala also emphasised that globally competitive manufacturing increasingly depends on combining speed with scientific precision. He explained that modern pharma excipient and coating technologies must deliver not only faster throughput, but also improved process robustness, regulatory compliance, and scalability.

The company’s focus on strong R&D capabilities, advanced polymer technologies, and global certifications reflects the broader trend of Indian pharma suppliers moving toward higher-value and technology-driven offerings. 

Quality becomes a strategic leadership function 

One of the summit’s most impactful discussions focused on the evolving role of quality within pharma organisations. Speaking on ‘Quality as Strategy: Winning Trust in Global Markets’, Ranjit Menon, Site Head – Indore Manufacturing, Cipla, pointed out that quality can no longer remain confined to compliance departments. 

He stated that, quality is no longer just compliance. It is a strategic leadership function driving business success, Menon highlighted how the pharma industry is increasingly moving toward patient-centric and risk-based quality systems. 

Rather than treating compliance as a checklist activity, companies are now expected to embed quality thinking into every stage of manufacturing, operations, decision-making, and leadership. The session focused extensively on the growing importance of data integrity and transparent decision-making. 

 According to Menon, regulatory confidence and market trust increasingly depend on the reliability, traceability, and transparency of manufacturing data. As global inspections become more sophisticated and digitally driven, pharma companies must create strong quality cultures where accountability and integrity are deeply embedded across functions.

The session also reinforced that quality excellence is no longer merely a regulatory expectation. It has become directly linked to business sustainability, global market access, and long-term reputation. 

Sustainability emerges as a business imperative 

In the session titled ‘Sustainability as Strategy: The Next Frontier for Pharma Leaders’, Vivek Asthana, Head EHS & Sustainability, Symbiotec Pharmalab, argued that ESG is rapidly becoming fundamental to pharma business continuity, investor confidence, and long-term competitiveness.

Asthana pointed out that sustainability can no longer be viewed as a peripheral corporate social responsibility initiative. Emphasising that it is fundamental to survival, credibility and growth.

The session highlighted how regulators, investors, customers, and global buyers are increasingly evaluating pharma companies not just on financial performance, but also on how responsibly those returns are generated. 

Asthana discussed how frameworks such as SEBI’s Business Responsibility and Sustainability Reporting (BRSR) requirements are in creasing pressure on companies to improve transparency around environmental, social, and governance practices. 

Global procurement trends are also evolving rapidly. According to Asthana, multinational customers and global pharma buyers are increasingly prioritising ethical, transparent, and sustainable manufacturing partners. The session highlighted that sustainability is gradually moving from a compliance-driven activity toward becoming a core business strategy influencing investment decisions, partnerships, procurement, and long-term market positioning.

Strengthening industry academia collaboration 

Talent development and industry-academia collaboration formed another important dimension of the summit discussions. Addressing the session on ‘Academia-Industry Collaboration for the Development of Future Pharma Professionals’, Prof (Dr) Neelesh Malviya, Principal, Smriti College of Pharmaceutical Education, Indore, highlighted the urgent need to bridge the gap between academic learning and industry requirements.

According to Prof Malviya, stronger academia-industry collaboration is essential for transforming research into commercially viable innovation. He explained that industry-aligned research can accelerate commercialisation, solve practical manufacturing and R&D challenges faster, and reduce development costs. The session emphasised that pharma education can no longer remain isolated from industry realities. 

Prof Malviya stressed that continuous interaction between academia and industry is critical to developing futureready pharma professionals capable of adapting to rapidly evolving technologies, regulatory systems, manufacturing techniques, and research environments. 

The discussion also highlighted how stronger collaboration can encourage entrepreneurship, modernisation, and sustainable societal growth. The broader message from the session was that India’s pharma growth ambitions will depend heavily on building stronger skilling ecosystems and creating a workforce capable of supporting future innovation-led growth. 

From molecule to market faster 

One of the summit’s most engaging and technically rich discussions was the panel discussion titled From Molecule to Market Faster: Rethinking Drug Development. 

Moderated by Sanjay Tiwari, Pharma Consultant, the panel featured Dayanand More, Head Site – Operation, Alembic Pharma; Nishikant Ghadge, VP (R&D and Manufacturing), Symbiotec Pharma; Nitin Tiwari, VP-CQA and Cluster Head (Indore, Dewas, Ratlam and Wardha), Ipca Laboratories; Dr Bipin Chaubey, Head of Site Process & Technology (Dewas), Sun Pharmaceutical Industries; Gopinath Santhosh, GM – Supply Chain Management, Felix Generics; and Dr Sharad Jain, AVP, PSA Chemicals and Pharmaceuticals.

The discussion focused on one of the pharma industry’s biggest challenges: how to accelerate drug development and commercialisation timelines without compromising quality, scientific rigor, or patient safety. 

Panelists repeatedly emphasised that speed alone cannot define successful pharma development. Instead, the future of drug development will depend on balancing scientific understanding, process robustness, analytical excellence, supply chain resilience, and regulatory readiness. 

The panel highlighted the growing importance of strong API and Key Starting Material (KSM) ecosystems in enabling resilient and faster pharma development. Given increasing geopolitical disruptions and supply chain volatility, speakers stressed that India must continue strengthening domestic API and intermediate capabilities to reduce dependency risks. 

Another major takeaway was the importance of cross-functional collaboration. The panelists agreed that faster commercialisation increasingly depends on stronger coordination between R&D teams, API manufacturers, regulators, analytical experts, supply chain partners, and logistics providers. 

The discussion also explored the transformative role of AI and digital technologies across pharma development. According to the speakers, AIenabled systems are increasingly reshaping drug discovery, clinical trial management, regulatory workflows, documentation systems, process optimisation, and manufacturing analytics. Digital tools are helping pharma companies reduce timelines while simultaneously improving process efficiency, data visibility, and decisionmaking accuracy.

Integrated supply chains emerged as another critical requirement. The panel highlighted that robust end-to-end visibility across procurement, development, manufacturing, and logistics operations is essential for reducing delays from molecule development to market launch.

The session also highlighted the often-underestimated role of logistics. Speakers pointed out that maintaining product integrity during transportation is just as important as manufacturing quality itself, particularly for temperature-sensitive and complex pharma products. 

Overall, the panel reinforced that future pharma competitiveness will depend not only on innovation speed, but on the ability to build scientifically robust, digitally connected, and operationally resilient development ecosystems. 

India’s CDMO opportunity 

Speaking on ‘CDMO Opportunity: India’s Next Manufacturing Advantage’, Gajanan Patil, COO, H&H Healthcare and Cosmetics, highlighted how the global pharma industry is increasingly shifting from traditional manufacturing models toward strategic CDMO partnerships. 

According to Patil, pharma companies worldwide are seeking manufacturing partners capable of delivering cost efficiency, speed, innovation, flexibility, and supply chain resilience. He noted that the ongoing China+1 strategy is creating significant opportunities for Indian pharma manufacturers. India’s scientific talent base, regulatory credibility, manufacturing capabilities, and cost competitiveness position the country strongly to capture the next wave of global CDMO growth. 

Patil also highlighted the strategic advantages of the Indore-Pithampur pharma ecosystem. According to him, the region possesses strong infrastructure, export capabilities, logistics connectivity, industrial ecosystems, and talent availability that could help it emerge as a major global pharma CDMO hub. 

The session highlighted that India’s future manufacturing opportunity lies not just in scale-based manufacturing, but in building integrated development and manufacturing partnerships capable of supporting complex global pharma programmes. 

Indore: Next manufacturing powerhouse 

The summit concluded with a high-energy panel discussion titled ‘Indore Rising: Central India’s Next Manufacturing Powerhouse’. 

Moderated by Dr Vipin Saxena, Director, Vishwa Life Sciences, the panel featured Paresh Chawla, MD, Alpa Laboratories; Amit Chawla, Director, McW Healthcare; Tapan Das, Sr GM – Quality, Sun Pharmaceutical Industries; Mahendra Kumar Sahu, GM, Sun Pharmaceutical Industries; Nikhil Sahu, Sr Group Leader and Head – Packaging Development, Knovea Pharmaceuticals; and Praveen Jindal, Deputy Chief Manager, Piramal Pharma (Pithampur). 

The discussion focused on how Madhya Pradesh — particularly the Indore-Pithampur belt — is steadily emerging as one of India’s important pharma manufacturing ecosystems. Panelists highlighted that proactive governance, infrastructure support, industrial policies, and subsidies are helping create a more industry-friendly environment for pharma investments in the state. 

However, the panel also acknowledged several operational challenges that continue to affect pharma MSMEs. One of the biggest concerns raised during the discussion was skilled manpower retention. Despite the region’s growing industrial ecosystem, retaining technically skilled professionals remains a challenge for several companies.

The panel also discussed delayed payment cycles and their impact on MSME cash flows, operational stability, and expansion plans. Another major theme was the need to strengthen local support ecosystems. According to the panelists, Indore’s next phase of growth cannot rely solely on manufacturing expansion. 

Instead, the region must build integrated local ecosystems across R&D, testing laboratories, packaging development, analytical services, regulatory support, and specialised pharma services. 

The discussion also explored the role of pharma parks and allied industrial clusters. Panelists emphasised that integrated pharma parks with connected ancillary industries can significantly improve collaboration, productivity, operational efficiency, and supply chain coordination.

The issue of skilling remained central throughout the panel discussion. Speakers repeatedly stressed that the future competitiveness of India Pharma Inc will ultimately depend on continuous skill upgradation. As pharma manufacturing technologies, materials, automation systems, and regulatory expectations evolve rapidly, the industry must continuously invest in workforce development. 

The panel also emphasised the need for stronger industry academia collaboration to build professionals who are truly industry-ready from the beginning of their careers. According to the panelists, pharma education itself must evolve with deeper industry participation and more practical, application-driven learning.

Way forward 

As the Indore Pharma Summit 2026 concluded, one message resonated across every session and panel discussion: India’s pharma industry stands at a defining inflection point. The future of India Pharma Inc will depend on how effectively the industry builds innovation capabilities, integrates AI and automation, strengthens quality systems, develops sustainable operations, accelerates drug development, creates resilient supply chains, and nurtures future-ready talent. 

As India seeks to strengthen its global pharma leadership position, emerging ecosystems beyond traditional pharma clusters are expected to play a critical role in supporting the industry’s next phase of growth.

The Indore Pharma Summit 2026 showcased more than just industry perspectives. It reflected a larger transition underway within Indian pharma itself — from scale-driven growth toward innovation-led, technology-enabled, quality-centric, and globally competitive development. 

And as industry leaders repeatedly emphasised throughout the summit, the companies and ecosystems that succeed in the coming decade will be those willing to evolve continuously, collaborate deeply, and prepare proactively for the future. 

swati.rana@expressindia.com

swatirana.express@gmail.com

The post Indore Pharma Summit: Mapping the future of India pharma appeared first on Express Pharma.

Parexel has announced that it will participate in eight sessions at the 2026 Drug Information Association (DIA) Global Annual Meeting, scheduled to take place in Philadelphia from June 14 to 18, 2026.

According to the company, executives and subject matter experts will present, moderate and participate in panel discussions covering artificial intelligence applications across the clinical trial lifecycle, real-world evidence, risk-based quality management and patient-centred research.

Katie Connelly, Senior Vice President and Global Head of Regulatory Affairs, will speak during session #425 IT, titled “The Connected Submission — How AI, Automation, and Intelligence are Changing the Regulatory Ecosystem”, on June 15 from 1:05 p.m. to 1:35 p.m.

Aneiss Ghodsi, Head of AI Engineering, will present during session #503 IT, “Human-Centered AI — A Dual-Layer Model for Clinical Research Excellence”, on June 16 from 9:15 a.m. to 9:45 a.m.

Stacy Hurt, Chief Patient Officer, will speak during session #515, “Leveraging Federated AI and Open Data to Transform Oncology Research and Development”, on June 16 from 10:15 a.m. to 11:30 a.m. She will also participate in session #521.1, “Patient Appreciation Session: Celebrating the Patient Voice”, on June 16 from 11:45 a.m. to 12:30 p.m., and moderate session #701, “No Report Left Behind: Human-Centered Safety Reporting”, on June 18 from 8:00 a.m. to 9:00 a.m.

Mike D’Ambrosio, Senior Vice President and Global Head of Real World Research, will serve as a panellist during session #519, “Patient Registries: Basket Trial or Basket Case?”, on June 16 from 10:15 a.m. to 11:30 a.m.

Cris McDavid, Senior Director of Clinical Operations, will participate as a panellist in session #637, “Destigmatizing 483 Observations”, on June 17 from 1:45 p.m. to 2:45 p.m.

Tala Fakhouri, Chief AI and Regulatory Strategy Officer, will participate as a panellist during session #647, “Not Can, but Should: How do we WANT AI/ML to Transform Clinical Development?”, on June 17 from 4:00 p.m. to 5:00 p.m.

Keri Mattox, Chief Business and Strategy Officer, Parexel, said, “DIA is a premier forum for advancing clinical development innovation, and Parexel is proud to showcase how AI, clinical trial innovation and human-centered approaches are transforming the industry. Our participation reflects Parexel’s commitment to research and thought leadership, and our dedication to accelerating the delivery of safe, effective therapies to patients worldwide.”

The Drug Information Association is a multidisciplinary organisation that brings together professionals from across the life sciences industry. The organisation serves as a platform for knowledge exchange through educational resources, conferences and collaboration among stakeholders.

The post Parexel to present at eight sessions during DIA Global Annual Meeting 2026 appeared first on Express Pharma.

According to the agreement, the partner biopharmaceutical company will provide an upfront payment and fund the early research and development efforts of XtalPi.

XtalPi also stands to receive further payments based on preclinical, clinical and commercial milestones, as well as future royalties.

The company stated that the targeted GPCR presents significant challenges because of its extreme conformational plasticity, making its ligand-binding pockets difficult for small molecules to engage selectively.

To address these limitations, XtalPi’s research and development team employed multiscale enhanced sampling simulations to map the receptor’s functional conformational landscape.

They then used a dynamic, multi-conformational screening strategy. Applying advanced quantum physics models and AI algorithms, XtalPi conducted virtual screening of several compounds and utilised its XFEP (Free Energy Perturbation) platform for accurate binding affinity prediction.

As the collaboration progresses, XtalPi will use its structure-based drug design platform, integrating quantum physics, generative AI, and large-scale automated chemical synthesis enabled by a multi-agent system.

XtalPi chairman Dr Shuhao Wen said: “This collaboration underscores our deep commitment to supporting top-tier biopharmaceutical companies with robust, scalable AI and robotics capabilities.

“At XtalPi, we design our platform to act as the essential infrastructure for innovation — helping our partners reliably translate complex biological challenges into strong pipeline assets.

“We are excited to combine our technological strengths with our partner’s clinical vision to advance accessible, highly effective oral therapies in the metabolic space.”

The post XtalPi enters $400m partnership for small molecule therapy for GPCR target appeared first on Pharmaceutical Business review.

AstraZeneca Pharma India (AZPIL) announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Trastuzumab Deruxtecan 100 mg/5 mL vial lyophilised powder for concentrate for solution for infusion, in combination with Pertuzumab, as a first-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer.

Breast cancer remains one of the most common cancers affecting women worldwide, while HER2-positive breast cancer is among its forms. In India, HER2-positive breast cancer, defined by HER2 gene amplification or protein overexpression, is estimated to account for approximately 12 to 19 per cent of breast cancer cases.

According to AstraZeneca, unmet need remains significant in the metastatic setting. The company stated that no new first-line therapies have enhanced outcomes for patients with HER2-positive metastatic breast cancer in recent years. It further noted that approximately one-third of patients treated in the first-line setting do not go on to receive second-line therapy, highlighting the importance of treatment in the early course of disease.

The approval is based on results from the DESTINY-Breast09 trial, which included patients from India. In the trial, Trastuzumab Deruxtecan plus Pertuzumab demonstrated a statistically significant improvement in progression-free survival (PFS) by blinded independent central review (BICR) compared with the THP regimen comprising taxane, trastuzumab and pertuzumab.

Median progression-free survival was 40.7 months for Trastuzumab Deruxtecan plus Pertuzumab compared with 26.9 months for THP, representing a 44 per cent reduction in the risk of disease progression or death. According to the company, the benefit was observed across subgroups.

Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited, said, “This approval marks an important step forward for patients with unresectable or metastatic HER2-positive breast cancer in India, where the need for more effective treatment options in the first-line setting remains high. For many patients, the initial treatment decision can shape outcomes across the course of their disease, making early access to innovation especially important. At AstraZeneca, our purpose is to transform patient outcomes through science, and we are committed to accelerating the introduction of important new medicines to India, helping patients access advances in care sooner while working with the broader healthcare ecosystem to reduce barriers and improve quality of life.”

Current approved indications for trastuzumab deruxtecan include the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen; HER2-low and HER2-ultralow breast cancer in specified metastatic settings; locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma following a prior anti-HER2-based regimen; and other unresectable or metastatic HER2-positive (IHC 3+) solid tumours after prior systemic treatment where no satisfactory alternative treatment options exist.

AstraZeneca stated that the approval expands treatment options for patients with breast cancer and supports its efforts to address unmet need through science-led innovation.

The post CDSCO approves Trastuzumab Deruxtecan for first-line HER2-positive breast cancer appeared first on Express Pharma.

Glenmark Specialty S.A. (GSSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals, has announced the launch of Winlevi (clascoterone 10 mg/g cream) across key markets in Europe.

The launch follows the grant of marketing authorisation by the European Commission to Cassiopea S.p.A., a subsidiary of Cosmo N.V., in October 2025 for the treatment of acne vulgaris in adults and adolescents aged 12 to less than 18 years, with use in adolescents limited to facial application.

Glenmark has initiated direct launches in several European markets, including the Nordics, Central and Eastern Europe, and Spain. In Portugal, the company has launched the product through a strategic partner. Glenmark is also advancing additional launches through strategic partnerships across other European markets.

The product is authorised in the European Union for the treatment of acne vulgaris in adults and adolescents. It was developed by Cassiopea, which holds rights across Europe and collaborates with regional partners for commercialisation.

According to the company, acne vulgaris is one of the most common dermatological conditions globally. More than 95 per cent of males and 85 per cent of females experience acne during adolescence, while 50 per cent continue to experience it in adulthood.

Winlevi is a topical acne therapy with a mechanism of action based on clascoterone. The active ingredient is a topical androgen-receptor inhibitor that acts locally in the sebaceous glands to reduce sebum production and inflammation without systemic anti-androgen effects. The product is intended for use in both males and females and provides an additional treatment option for healthcare professionals and patients in Europe.

The company stated that the launch forms part of its dermatology growth strategy and its focus on expanding access to therapies across global markets. It also supports Glenmark’s approach to multi-market launches in Europe through a combination of direct presence and strategic partnerships.

Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented, “The European launch of Winlevi represents an important milestone for Cosmo and reflects the strength of our collaboration with Glenmark. This achievement supports our strategy of expanding the global reach of our innovative dermatology portfolio through trusted partnerships and disciplined execution. We are pleased to see Winlevi becoming available to patients across Europe and look forward to continuing to build on the momentum of our long-term partnership with Glenmark.”

Jiri Havranek, Group Vice President and Business Head – Europe, Glenmark Pharmaceuticals, commented, “This launch is an important step in strengthening Glenmark’s dermatology portfolio and advancing our branded business in the region. As Glenmark’s first NCE launch in Europe, it reflects our focus on bringing differentiated treatment options to patients through disciplined execution, strong market access alignment and meaningful partnerships. We remain committed to expanding access to therapies that address unmet needs and support better outcomes for patients.”

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India’s pharmaceutical market could reach USD 120–130 billion by 2030 from an estimated USD 55 billion in 2025, while pharmaceutical exports crossed USD 30 billion in FY 2024–25, according to ASSOCHAM’s knowledge paper, Outlook on the Indian Pharmaceutical Sector.

The report stated that India supplies approximately 20 per cent of the world’s generic medicines by volume and contributes more than half of UNICEF’s vaccine procurement requirements, highlighting the country’s role in global healthcare supply chains.

In the foreword to the knowledge paper, Saurabh Sanyal, Secretary General, ASSOCHAM, said India has built a reputation as a supplier of medicines and vaccines, supported by manufacturing capabilities, scientific talent and the policy ecosystem. He noted that the sector’s next phase of growth would be driven by innovation, advanced therapies, artificial intelligence-led drug discovery, biosimilars and regulatory excellence. He also highlighted the need for higher investment in research and development, stronger industry-academia collaboration, future-ready talent and globally aligned regulatory standards.

According to the report, the next phase of growth will be driven by a global patent cliff on biologics, demand for advanced therapies, advances in artificial intelligence-driven drug discovery and geopolitical realignment of pharmaceutical supply chains.

The knowledge paper stated that biologics generating more than USD 40 billion in annual revenues are expected to lose exclusivity between 2025 and 2029, creating opportunities for biosimilar manufacturers. It added that the global biosimilars market, valued at USD 39.6 billion in 2025, is projected to reach USD 151.6 billion by 2033.

The report further stated that India’s bioeconomy has exceeded USD 150 billion and is projected to reach USD 300 billion by 2030, with biologics and biopharma expected to be growth drivers. It noted that government initiatives including Biopharma SHAKTI, Bio-RIDE and the BioE3 Policy are supporting the creation of an ecosystem linking research, manufacturing and commercialisation.

According to the knowledge paper, innovation, advanced therapies, biologics, artificial intelligence-led drug discovery, regulatory excellence and research-led development will shape the future of India’s pharmaceutical ecosystem. The report also highlighted the need for greater investment in research and development, stronger industry-academia collaboration, future-ready talent and globally harmonised regulatory frameworks.

The report outlined five strategic priorities for India Pharma 2030: global regulatory alignment and quality leadership; translational science and innovation financing; biologics and cell and gene therapy manufacturing leadership; pharma talent and research capability development; and domestic access, innovation adoption and Global South leadership.

According to the report, pursuing these priorities with consistency and coordination could enable India to achieve pharmaceutical exports approaching USD 75–80 billion by 2030, strengthen its position as a destination for pharmaceutical innovation and biologics manufacturing, and emerge as a leader in biosimilars and advanced therapies.

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Alembic Pharmaceuticals has announced that it has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Larotrectinib Capsules, 25 mg and 100 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Vitrakvi Capsules, 25 mg and 100 mg, of Bayer Healthcare Pharmaceuticals Inc.

Larotrectinib is a kinase inhibitor indicated for the treatment of adult and paediatric patients with solid tumours that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or have progressed following treatment. The company advised referring to the product label for the complete indication.

According to the most recent update to the USFDA’s online Paragraph IV database listings, Alembic is the sole first applicant to have filed its ANDA for Larotrectinib Capsules, 25 mg and 100 mg, containing a Paragraph IV certification under the Hatch-Waxman Act.

The company stated that upon final approval of the ANDA by the USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the United States.

According to IQVIA data for the twelve months ending March 2026, Larotrectinib Capsules, 25 mg and 100 mg, have an estimated market size of US$91 million.

With this development, Alembic has a cumulative total of 241 ANDA approvals from the USFDA, comprising 221 final approvals and 20 tentative approvals.

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Axplora has announced the consolidation of ursodeoxycholic acid (UDCA) manufacturing at its Vizag facility in India, which operates under the PharmaZell business unit. The company stated that production will transition fully from its Gropello Cairoli facility in Italy, part of the Farmabios business unit, by the end of 2026.

The move follows Axplora’s previously announced investment in Vizag to expand UDCA manufacturing capacity and establish an integrated production platform covering bile sourcing through to active pharmaceutical ingredient (API) manufacturing.

According to the company, the consolidation forms part of its strategy to strengthen its position as a drug substance provider by maintaining its focus on APIs. The company stated that the move also aligns with its approach of leveraging the capabilities of its PharmaZell, Farmabios and Novasep CDMO business units to support operational focus, scalability and customer requirements.

UDCA is a bile acid-derived API used in therapies for chronic liver and gallbladder diseases. Axplora stated that demand for UDCA continues to increase globally due to the diagnosis and treatment of chronic liver conditions, healthcare access in emerging markets and the pharmaceutical industry’s focus on specialty therapies requiring API supply.

Manufacturing at the Vizag facility uses Axplora’s enzymatic synthesis route, which the company said reduces process steps and minimises the use of solvents and reagents compared with conventional manufacturing methods. The site also incorporates backward integration and traceability through controlled bile sourcing and integrated API production.

The Vizag facility has received an EcoVadis Silver sustainability rating. According to the company, the site operates using the same enzymatic process and manufacturing standards as the Gropello facility while providing expansion capacity, integrated operations and access to US FDA-approved infrastructure.

Martin Meeson, Chief Executive Officer, Axplora, said:

“This decision reflects the strategic advantage of Axplora’s integrated global network and our ability to align investments with evolving customer needs. By consolidating UDCA manufacturing at Vizag, we are creating a more streamlined and scalable supply platform that strengthens resilience, simplifies operations and enhances service for customers worldwide.

At the same time, it reinforces Farmabios’ position as a leading centre of excellence for highly potent APIs. As demand for increasingly complex and potent therapies continues to grow, we are focusing the site on the advanced containment and HPAPI capabilities where it delivers exceptional value to customers.”

The company stated that Farmabios is recognised for its steroid and highly potent active pharmaceutical ingredient (HPAPI) handling capabilities and operates an OEB5 manufacturing workshop in Europe. The facility supports complex and highly potent therapeutics within Axplora’s manufacturing network.

Anant Barbadikar, President, PharmaZell – Operations, said:

“Our Vizag site has become an increasingly important strategic hub within Axplora’s global manufacturing network. This consolidation reflects the technical expertise, operational excellence and regulatory track record of our Indian teams.

For customers, the benefits are clear: a fully integrated manufacturing platform, robust and traceable supply chains, scalable capacity and enhanced responsiveness. We are bringing together deep process expertise and operational efficiency to support long-term customer partnerships and reliable global supply.”

Axplora stated that regulatory approvals for the transition are now in place and that UDCA is being manufactured at the Vizag site. The company added that following a recent US FDA inspection, the facility is positioned to support customer demand and market growth through its integrated operations and manufacturing capacity.

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The validation confirms the application is complete and initiates the EMA’s centralised procedure.

Bayer continues regulatory submissions for asundexian to other agencies, with priority review recently granted by China’s Center of Drug Evaluation and the US Food and Drug Administration (FDA).

The application is supported by data from the Phase III international, multi-centre, placebo-controlled, double-blind, randomised OCEANIC-STROKE study.

The trial randomised 12,327 participants worldwide. It compared asundexian 50mg once-daily plus antiplatelet therapy to placebo and antiplatelet therapy in patients following non-cardioembolic ischaemic stroke or high-risk TIA.

Its primary efficacy endpoint measured time to ischaemic stroke while the primary safety endpoint was International Society on Thrombosis and Hemostasis (ISTH) major bleeding.

Results published in The New England Journal of Medicine found that asundexian reduced ischaemic stroke by 26% without increasing ISTH major bleeding.

Asundexian is an investigational compound not yet approved in any country.

Bayer Pharmaceuticals global research and development head Christian Rommel said: “Between 2010 and 2019, the prevalence of ischaemic stroke and stroke-related mortality increased by 4% and 7%, respectively, across EU member states, underscoring the growing burden of this disease.

“The acceptance of our marketing authorisation application by the EMA is a testament to our unwavering commitment to offering patients in need novel treatment options.”

In June 2025, Bayer subsidiary Vividion Therapeutics secured exclusive worldwide rights to develop and commercialise VVD-214, the Werner helicase covalent inhibitor, enhancing its oncology pipeline.

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Following the close, the acquisition corporation and Ignite will become wholly owned subsidiaries of the newly formed holding company.

The new company’s public warrants and common stock are anticipated to be listed on the New York Stock Exchange, pending approval of the application and customary closing conditions.

Aditxt acquired Ignite with the intention of identifying and advancing differentiated health innovation platforms.

The planned business combination is described as providing Ignite with a dedicated public company structure and increased access to growth capital.

Aditxt Interim CEO and Ignite Proteomics CEO Jeff Busch said: “Aditxt owns 100% of Ignite, a differentiated precision oncology asset, and this transaction is expected to unlock that value through a business combination that values Ignite at approximately $150m.

“For Ignite, becoming an independent public company is expected to provide the focus, visibility and access to capital needed to accelerate commercialisation, expand clinical evidence generation and pursue broader adoption of its functional proteomics platform in oncology.”

Ignite focuses on the development and commercialisation of a proteomics platform aimed at improving physicians’ understanding of biological activity in tumours.

Its core programme targets commercialisation in breast cancer, with plans to expand to further tumour types and clinical settings.

The transaction proceeds are expected to support Ignite’s working capital and general corporate requirements.

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UK Science Minister Lord Vallance unveiled the scheme during London Tech Week and aims to create a controlled environment where companies and researchers can work with regulators to explore AI-driven methods for understanding the safety of medicines and predicting any side effects.

Each year, adverse drug reactions result in around 250,000 hospital admissions in the UK, costing the National Health Service (NHS) over £2bn ($2.67bn).

Additionally, approximately 90% of medicines fail at the time of development, partly because current methods cannot always predict how drugs will perform in patients.

The new MHRA sandbox will allow innovators to test AI systems and assess the behaviour of medicines within the body.

Funding for the programme comes from the UK Government’s Regulatory Innovation Office. The initial phase is expected to include up to five AI-driven approaches.

The agency will collaborate with the industry and academic groups from summer 2026 to define the sandbox’s operational details.

The objectives include examining how AI might improve predictions about drug absorption, processing, and potential harm, as well as enhancing assessment by using clinical data from groups often underrepresented in clinical studies, such as children, older adults, and people from diverse backgrounds.

The MHRA intends to use findings from the sandbox to evaluate the reliability of AI tools in making decisions about new medicines’ safety.

Improving evidence and clarifying expectations for safe AI usage are expected to encourage investment in UK healthcare innovation.

The initiative forms part of broader efforts to modernise medicine development, with a focus on advanced modelling and synthetic data.

UK Health Innovation Minister Preet Gill said: “The AI revolution is here, and we want our NHS staff to be the first in the queue, armed with rigorously tested clinical AI tools.

“By giving innovators a safe space to test these tools alongside regulators, we can build the evidence base needed to get safer, more effective treatments to patients faster. That means fewer adverse reactions, less reliance on animal testing, and a smarter, more efficient medicines development process.

“Through our 10 Year Health Plan, we are driving the NHS to be the most AI-enabled healthcare system in the world.”

In March 2026, the MHRA and the National Institute for Health and Care Excellence made their decisions on new drugs concurrently, following changes to the UK’s medicine regulation process.

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Nine years ago, Ozempic was launched as a diabetes drug that most people outside of endocrinology circles had never heard of. Today, it’s a cultural reference point – name-dropped in late-night monologues, debated in nutrition circles, and quietly reshaping how the medical fraternity approaches one of the most stubborn health challenges of the modern era.

But Ozempic is just the beginning. The story of GLP-1 receptor agonists is moving fast, and the business behind it is moving faster.

How we got here

GLP-1 or glucagon-like peptide-1 is a hormone that the gut naturally produces in response to eating. It signals the pancreas to release insulin, slows digestion, and crucially, tells the brain that the body has had enough. Scientists have understood its function for decades. What took time was figuring out how to harness it pharmacologically in a way that was both effective and practical for patients.

Semaglutide, the active compound in Ozempic and Wegovy, was the breakthrough that changed the commercial trajectory. Weekly injections. Significant, consistent weight loss in clinical trials. And a tolerability profile that, while not without side effects, was manageable for most patients. The market responded accordingly. Novo Nordisk, the Danish company behind both products, became one of the most valuable companies in Europe almost overnight. Eli Lilly followed closely with tirzepatide – branded as Mounjaro for diabetes and Zepbound for obesity – targeting both GLP-1 and GIP receptors simultaneously and producing weight loss results that raised the clinical bar even further.

The numbers behind this market are staggering. Analysts project that the global obesity drug market, currently valued in the tens of billions, could exceed $150 billion annually within the next decade. In India, the opportunity is equally significant. According to various estimates, over 135 million Indians are overweight or obese, with a rising incidence in urban populations driven by sedentary lifestyles and dietary shifts. Despite this, access to clinically effective obesity treatments remains limited, pointing to a large untapped market as awareness and affordability improve. That kind of projection doesn’t just attract pharmaceutical giants. It pulls in biotech startups, venture capital, and research institutions, all looking for the next compound that can do what semaglutide did, but better.

The next generation is already in development

The pipeline beyond current GLP-1 drugs is genuinely exciting from a scientific standpoint. Triple agonists – compounds that target GLP-1, GIP, and glucagon receptors simultaneously are showing early-stage results suggesting even greater metabolic impact than anything currently approved. Retatrutide, one of the candidates furthest along in this category, produced weight loss figures in phase two trials that surprised even researchers familiar with the space while simultaneously improving muscle mass, which has long been considered a major side effect of semaglutide.

Oral formulations are another frontier drawing significant investment. Current GLP-1 drugs require injection, which limits patient access and compliance. Oral semaglutide already exists for diabetes management, but achieving effective absorption at doses sufficient for meaningful weight loss has been a formidable pharmaceutical engineering challenge. Several companies are working on novel delivery mechanisms like lipid nanoparticles, enteric coatings, and absorption enhancers that could eventually make weekly injections optional rather than necessary.

There’s also serious research interest in combining GLP-1 mechanisms with muscle-preservation compounds. One of the consistent criticisms of current GLP-1 therapies, which is also backed by real clinical data, is that a significant portion of weight lost during treatment comes from lean mass rather than fat alone. For long-term metabolic health, that’s a problem. Next-generation formulations pairing GLP-1 activity with agents that stimulate muscle protein synthesis could address this directly, producing fat loss without the muscle depletion that currently requires patients to work hard around with diet and exercise.

The access problem the industry can’t ignore

For all the clinical promise, the business of GLP-1s has an uncomfortable underbelly: these drugs are expensive, and the gap between who needs them and who can access them is wide.

Monthly costs for branded GLP-1 medications in markets without broad insurance coverage run into hundreds, sometimes over a thousand dollars. In India, GLP-1 therapies typically cost in the range of ₹10,000 to ₹25,000 per month, making them inaccessible for a large portion of the population. Insurance coverage for obesity treatment is also largely absent, meaning patients bear the full cost out-of-pocket. This creates a significant barrier in a country with a rapidly growing obesity burden.

The longer-term solution lies in generic and biosimilar development, which is already underway in India. With the patent having already expired in March, the Indian market has witnessed the launch of multiple domestic versions, with various brands already entering the space. This influx is expected to intensify in the coming months, driving greater price competitiveness and significantly improving accessibility for a wider consumer base. The companies that figure out how to sustainably reduce cost-of-access without eroding clinical quality will define the next chapter of this market, particularly across emerging economies where obesity rates are rising sharply but purchasing power for premium therapeutics is limited.

What this means for healthcare

The broader implication of effective obesity pharmacotherapy is only beginning to be understood. GLP-1 drugs are showing signals of some benefits in formal trials, others are observational of benefits that extend well beyond weight: reduced cardiovascular events, potential impact on sleep apnea, early data on neurological conditions, and reduced joint loading that could delay orthopedic interventions.

If even a fraction of those signals hold up at scale, the downstream impact on healthcare systems in reduced comorbidity burden, fewer hospitalisations, and lower long-term treatment costs could be enormous.

The business of GLP-1s is booming right now. The science of what these compounds might ultimately be capable of is still being written. And the gap between what’s available today and what’s coming in the next five to ten years is wider and more interesting than most people realise.

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At a time when access to reproductive treatment remains limited, Oval Advanced Fertility Care and Merck Specialities, the Indian healthcare arm of Merck KGaA, Darmstadt, Germany, have signed a Memorandum of Understanding (MoU). The collaboration aims to enhance access to fertility care by strengthening clinical capabilities, improving transparency and patient experience, and driving treatment outcomes through integrated expertise, technology and data-led approaches.

India’s IVF market, valued at approximately USD 2.35 billion in 2024, is projected to reach USD 5.03 billion by 2034, growing at a compound annual growth rate of 7.9 per cent. According to the companies, market growth alone does not ensure better outcomes for patients. The collaboration aims to address the gap between market expansion and treatment standards by combining scientific expertise, digital innovation, patient support frameworks and clinical capability building to improve access and treatment outcomes.

Ms. Veena Reddy, Co-Founder and Director, Oval Fertility, said, “When we set out to build Oval, we were clear that we wanted to offer care that goes well beyond the procedure since India’s fertility landscape is at an important juncture. The gap between the number of couples who need care and those who actually receive quality treatment remains very wide. The partnership with Merck brings together shared values around transparency, clinical excellence, and putting the patient at the centre of every decision.”

Pratima Reddy, Managing Director, Merck Specialities,  said, “Fertility care in India is evolving rapidly, with patients seeking greater transparency, a more seamless experience, and stronger confidence in outcomes. As a leader in IVF, Merck is well positioned to partner with progressive care providers to address these expectations through an integrated approach, combining clinical expertise, advanced technologies, and data-driven insights. Through collaborations like this, we are committed to strengthening the fertility ecosystem and advancing more predictable, high-quality standards of care for patients across the country.”

According to the companies, studies estimate that approximately 15 to 20 per cent of Indian couples, nearly 30 million people, are affected by infertility, while only about 1 per cent of those requiring treatment receive it. The partnership aims to address these gaps through clinical capability building, access to evidence-based protocols and support for continuous medical education to improve patient outcomes.

Merck stated that it brings expertise across fertility treatments, IVF technologies and clinical education, supporting healthcare professionals in delivering evidence-based fertility care. Through its approach to therapeutics and reproductive technologies, the company continues to support innovation focused on improving fertility outcomes.

Oval Advanced Fertility Care is backed by GVK and is led by Dr. Brian Levine, Medical Director Dr. Sandeep Karunakaran and Reproductive Endocrinologist Dr. Keerthana Vemula. Located in Banjara Hills, Hyderabad, the clinic provides fertility services including IVF, IUI, ICSI, Preimplantation Genetic Testing, egg and sperm freezing, and fertility assessments.

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The Hashgraph Group (THG) has announced a strategic collaboration with Merck to extend its TrackTrace Digital Product Passport (DPP) platform. Built on Hedera and designed to support compliance requirements for global supply chains, the collaboration aims to address incoming European Union product transparency regulations related to product trust, quality and sustainability.

The initiative integrates THG’s digital traceability infrastructure with Merck’s M-Trust physical authentication technology. According to the companies, the collaboration has been enabled through Merck’s participation in the Enterprise Accelerator Programme of The Hashgraph Association, a Switzerland-based non-profit organisation focused on digital enablement, innovation and education within the Hedera ecosystem.

The technical integration combines THG’s Hedera-based traceability platform with Merck’s M-Trust authentication technology to provide proof of quality, traceability, authenticity and value transfer within a Digital Product Passport framework. The companies stated that Hedera will serve as the single source of truth for the system.

THG said that while TrackTrace creates tamper-proof digital records documenting a product’s origin and lifecycle, Merck’s M-Trust technology provides verification of the physical product itself. The integrated solution, which has already been demonstrated through a supply chain pilot scheduled to be announced, is designed to help businesses prepare for the European Union’s Digital Product Passport and deforestation traceability requirements.

The collaboration comes as new EU regulations increase product transparency obligations. The Ecodesign for Sustainable Products Regulation (ESPR) will require Digital Product Passports containing information on product origin, composition, sustainability credentials and lifecycle through QR codes from 2026 onwards. The EU Deforestation Regulation (EUDR) requires importers of commodities such as cocoa, coffee and timber to provide verified farm-level traceability data.

According to THG and Merck, the combined solution is intended to support organisations across the supply value chain in meeting applicable regulatory compliance requirements through integrated traceability and authentication systems.

The companies noted that product traceability is also linked to sustainability commitments, ethical sourcing, carbon reporting and consumer trust. They added that organisations making public claims regarding product origins increasingly require infrastructure capable of providing verifiable evidence.

The companies cited examples of traceability challenges in 2026, including rising cocoa and food fraud risks linked to high prices and regulatory requirements. Reported issues include blending lower-quality cocoa with fillers and falsification of deforestation-free certificates to comply with EUDR requirements.

Under the integrated system, Merck embeds invisible security markers into products and packaging using its pigment technology. When scanned with an M-Trust handheld device, product authenticity is verified, cryptographically signed and recorded within TrackTrace on the Hedera network. The resulting record becomes part of the product’s Digital Product Passport.

TrackTrace provides real-time tracking of origin, sourcing and carbon emissions data. It also supports the capture and integration of quality assurance data into the Digital Product Passport. Each tracked process receives a decentralised identifier that functions as a record containing data, credentials and validations. According to THG, authorised third parties can independently audit products, business processes and claims without relying on a central authority. The platform also supports automated reporting through integrated Agentic AI.

The companies stated that the combined architecture is intended for sectors where authenticity, provenance and regulatory compliance are required, including food, pharmaceuticals, luxury goods, electronics and industrial components.

“Digital records alone are not sufficient for high-stakes supply chains,” said Stefan Deiss, CEO and Co-Founder of The Hashgraph Group. “Enterprises need to prove the physical product is genuine, not just the paperwork. This unique integration with M-Trust covers all layers from the first mile to the last mile – physical authentication through Merck’s technology and digital verification through TrackTrace – creating the foundation for trusted Digital Product Passports across any industry.”

“Product authentication has always required bridging the physical and digital worlds,” said Dr Thomas Endress, Executive Director and Head of M-Trust in the Group Science & Technology Office of Merck. “Integrating M-Trust’s verification with TrackTrace’s digital traceability creates exactly the kind of end-to-end trust infrastructure that enterprises and regulators are asking for. This is what product authentication looks like when it is built for the scale and complexity of modern supply chains.”

THG stated that the collaboration follows a series of developments, including the launch of its IDTrust self-sovereign identity platform in August 2025, EcoGuard carbon credit platform in December 2025, and BrandBoost product in May 2026. The company said EcoGuard is currently deployed with government institutions in India and the Philippines.

According to THG, the company is positioning its Hedera-based infrastructure and enterprise Web3 product suite for further integrations and sector-specific deployments as demand for supply chain traceability, sustainability reporting and Digital Product Passport compliance continues to increase.

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The Department of Commerce, Government of India, organised an outreach programme at the Regional Office of the Pharmaceuticals Export Promotion Council of India (Pharmexcil) in Mumbai to showcase the Department’s achievements, reforms and policy initiatives undertaken over the last 12 years.

The programme was attended by representatives from industry associations, including the Indian Drug Manufacturers’ Association, Indian Pharmaceutical Alliance and International Pharmaceutical Excipients Council of India. Representatives from companies including ACG, FDC Limited and other stakeholders also participated.

During an interaction with the media, Mohit Yadav highlighted India’s export growth, market diversification and trade relations with partner countries. He said the Government is working with industry to strengthen export capabilities, improve competitiveness and support the transition from volume-led exports to value-led exports.

Yadav stated that the Indian pharmaceutical sector has grown from about US$20 billion in 2014 to nearly US$60 billion in 2026 and is expected to reach US$130 billion by 2030. He added that pharmaceutical exports increased from US$14 billion in FY2015 to about US$31 billion in FY2026, registering a compound annual growth rate of 7.4 per cent, with an ambition to reach US$50 billion by 2030.

He said India remains the third-largest producer of pharmaceuticals by volume, supplies around 20 per cent of global generic medicines demand and exports pharmaceutical products to more than 200 countries. More than 60 per cent of India’s pharmaceutical exports are directed to regulated markets.

According to Yadav, India offers quality, continuity and affordability in healthcare supply chains. He pointed to around 1,000 US FDA-registered sites in India, the highest number outside the United States, as evidence of the country’s regulatory footprint. He also cited India’s ability to supply medicines during disruptions, including the pandemic and recent geopolitical developments.

The Joint Secretary noted that Maharashtra remains an important contributor to India’s pharmaceutical sector. He said Mumbai, Pune, Chhatrapati Sambhajinagar, Tarapur and nearby clusters have developed as centres for pharmaceutical manufacturing, research, exports and skilled talent. He added that Maharashtra’s pharmaceutical industry employs more than 200,000 people, including pharmacists, scientists and manufacturing workers.

Industry representatives acknowledged measures introduced by the Government to improve ease of doing business and strengthen the export ecosystem. These include digital issuance of Registration-cum-Membership Certificates, digital Certificates of Origin, the Trade Connect ePlatform, the Trade Infrastructure for Export Scheme portal, the Export Promotion Mission, research and development-linked support measures, and initiatives focused on quality, compliance and market access.

Yadav also highlighted Biopharma SHAKTI, or Strategy for Healthcare Advancement through Knowledge, Technology and Innovation. The initiative has been proposed with an outlay of ₹10,000 crore over five years and aims to position India as a global biopharmaceutical manufacturing hub. The programme seeks to support domestic production of biologics and biosimilars, strengthen research and development, improve clinical trial infrastructure, promote collaboration among academia, research institutions and industry, and enhance India’s position in the global biologics supply chain.

He further stated that multinational pharmaceutical companies are increasingly establishing Global Capability Centres in India. These centres employ more than 100,000 professionals and have attracted investments exceeding US$1 billion. The centres support functions including analytics, clinical operations, regulatory science, pharmacovigilance, digital health and research.

The Joint Secretary said that India’s trade agreements with partners including the United Arab Emirates, Australia, United Kingdom, European Union, European Free Trade Association, Oman and New Zealand are expected to support market access, regulatory cooperation, investment partnerships and technology collaboration. He added that the India-EFTA Trade and Economic Partnership Agreement, supported by a commitment of US$100 billion in investment over 15 years, could create opportunities in life sciences, research, manufacturing and health technologies.

Looking ahead, Yadav said future growth will increasingly be driven by biosimilars, biologics, gene therapies, specialty medicines, vaccines, complex generics, contract manufacturing, medical devices and greater self-reliance in Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs), while generics will continue to remain the foundation of the sector.

He reiterated that India brings scale, skill, science, standards and social commitment to global healthcare. He added that the Department of Commerce will continue to work with industry stakeholders to maximise the benefits of trade agreements, address regulatory and geopolitical challenges and support India’s ambition to become a global hub for pharmaceuticals, innovation and drug development.

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GSK has announced that it has entered into an agreement to acquire Nuvalent, a Boston-based clinical-stage biopharmaceutical company, for $10.6 billion. The company said the acquisition is aligned with its strategy of acquiring assets with validated targets that address efficacy and/or tolerability limitations of existing standard-of-care therapies. The transaction includes three lung cancer products.

The acquisition includes zidesamtinib (NVL-520) and neladalkib (NVL-655), two next-generation selective ROS1 and ALK inhibitors for the treatment of non-small cell lung cancer (NSCLC). Both products have received FDA Breakthrough Therapy and Orphan Drug Designations and are currently under FDA review, with target decision dates of 18 September 2026 for zidesamtinib and 27 November 2026 for neladalkib.

Subject to FDA approval, GSK expects both products to launch in 2026. The acquisition also includes NVL-330, a HER2 inhibitor currently being evaluated in Phase I trials for HER2-altered NSCLC, as well as Nuvalent’s preclinical portfolio comprising multiple programmes developed through its precision medicine platform and clinical research capabilities.

Luke Miels, Chief Executive Officer, GSK, said: “Today’s acquisition is a multi-product deal, consistent with our approach to acquire assets that have clinically proven targets and meaningfully address an efficacy and/or tolerability gap. The two lead products are potential best-in-class assets that could launch this year if approved by the FDA and offer significant new treatment options to patients with two forms of non-small cell lung cancer.

The acquisition provides GSK with immediate new sales growth opportunities, improving profit contributions from 2027, and a platform in lung cancer for rapid expansion with Ris-Rez, our B7-H3 targeted ADC in phase III clinical development.”

According to GSK, data presented at the IASLC 2025 World Conference on Lung Cancer and the 2026 ASCO Annual Meeting demonstrated the profiles of zidesamtinib and neladalkib. The company stated that both products are designed to support longer treatment duration through target selectivity, treatment response, tolerability, blood-brain barrier penetration and broader coverage of ALK and ROS1 mutations.

GSK noted that ROS1- and ALK-altered NSCLC primarily affect non-smoking adults aged between 40 and 50 years. The company added that both products have accumulated treatment experience through clinical development programmes and patient assistance initiatives.

James Porter, PhD, Chief Executive Officer, Nuvalent, said: “Since our founding, we have leveraged our deep expertise in chemistry and structure-based drug design to develop a portfolio of novel, potentially best-in-class kinase inhibitors. Our close collaboration with leading physician-scientists and patient advocates has driven remarkable enrolment, accelerating development and building confidence in the clinical profile of these drugs. We’re excited that GSK has recognised the significant value these programmes can offer patients and shares our vision for practice-changing innovation. GSK’s proven track record, infrastructure, and expertise will support the successful commercialisation of zidesamtinib and neladalkib, as well as accelerate advancement of our broader discovery pipeline.”

Under the terms of the merger agreement, GSK will commence a tender offer within 10 business days to acquire all outstanding Class A and Class B common stock of Nuvalent at $124 per share in cash. The aggregate equity value of the transaction is estimated at $10.6 billion (£8.0 billion). Net of cash acquired, GSK’s aggregate investment is estimated at $9.4 billion (£7.1 billion).

The purchase price represents a 40 per cent premium to Nuvalent’s last closing share price and a 26 per cent premium to its 30-calendar-day volume-weighted average price (VWAP).

GSK stated that there is no change to its 2026 full-year guidance range of 7–9 per cent core operating profit and core earnings per share growth. The company expects the acquisition to contribute to revenue growth from 2027, support its ambition of achieving sales of more than £40 billion by 2031, and strengthen core operating profit through the dolutegravir loss of exclusivity period between 2028 and 2030.

The company expects accretion to core operating profit in 2027 and to core earnings per share in 2029, inclusive of synergies and reprioritisation. Assuming the transaction closes in the third quarter of 2026, GSK expects low single-digit percentage dilution to core earnings per share for FY2026, FY2027 and FY2028.

The transaction will be funded primarily through new and existing debt facilities and cash. GSK said it does not expect any impact on its credit rating and intends to maintain its investment-grade credit profile. The company also reiterated its commitment to the expected 70 pence dividend for 2026 and its progressive dividend policy thereafter.

The transaction remains subject to customary closing conditions, including the tender of a majority of Nuvalent’s outstanding Class A common stock and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act in the United States. Following completion of the tender offer, GSK expects to acquire the remaining shares through a second-step merger under Delaware law at the same price per share.

GSK will account for the transaction as a business combination and will assume Nuvalent’s existing revenue-sharing arrangements involving low-single-digit royalties payable to Royalty Pharma and Deerfield.

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The companies stated that the Firelink DAC technology could enable more precise delivery of protein degraders to tumour cells, minimising impact on healthy cells.

Firefly Bio’s platform is in the preclinical stage and is designed to address limitations of current therapies for Kirsten rat sarcoma viral oncogene homologue (KRAS)-driven cancers.

J&J innovative medicine research and development division executive vice-president John Reed said: “KRAS has notoriously been considered an undruggable target and patients with KRAS-driven cancers continue to face limited treatment options with survival measured in months, not years.

“We believe the proprietary Firelink platform will overcome the limitations of current treatments and diversify our pipeline with preclinical candidates for treating multiple types of solid tumours.”

The transaction is expected to close later this year, subject to regulatory approvals and other customary closing conditions.

Firefly Bio is focused on advancing its Firelink DAC platform in cancer indications where treatment options remain limited.

J&J said it has pursued oncology innovation for more than 30 years and that Firefly Bio’s technology will complement its existing antibody-engineering capabilities.

The announcement did not include details on regulatory submission timelines or potential launch dates.

In March 2026, the US Food and Drug Administration (FDA) approved J&J’s Icotyde (icotrokinra) for the treatment of plaque psoriasis, marking the first US entry of an oral peptide in the indication.

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Hympavzi is approved for routine prophylaxis to prevent or decrease bleeding episodes in US adults and children aged six years and above with congenital factor VIII or IX deficiency, with or without corresponding inhibitors.

Hympavzi is administered as a once-weekly subcutaneous injection and does not require ongoing treatment-related laboratory monitoring.

Haemophilia, which often presents in early childhood, is characterised by impaired blood clotting. This increases the risk of painful bleeding, especially in the joints, which can lead to joint damage and scarring.

Phase III BASIS trial results supported Hympavzi approval in adults and adolescents with inhibitors, showing a 93% reduction in mean treated annualised bleeding rate compared to on-demand intravenous agents.

Interim data from the Phase III BASIS KIDS trial in children aged six to 17 years demonstrated improved bleeding outcomes versus historical controls.

Reported adverse reactions included injection site reaction, headache, fever, joint pain, diarrhoea, itching, and rash. Two thromboembolic events occurred among 259 patients in an open-label extension.

Thromboembolic events, hypersensitivity, embryofetal toxicity, and laboratory anomalies are highlighted in the Warnings and Precautions section of the US label.

Hympavzi’s application underwent FDA priority review and received breakthrough therapy designation for younger paediatric patients with haemophilia B, expediting the review process.

Pfizer US commercial division chief commercial officer and executive vice president Aamir Malik said: “With this expanded approval, we believe Hympavzi can become a transformative option and meet a significant medical need for people living with haemophilia A or B with or without inhibitors aged six years and older.

“Particularly for children ages six to 11 with haemophilia B who will now, for the first time, have a subcutaneous non-factor treatment available.

“This milestone represents the latest step in Pfizer’s more than 40-year commitment to advancing care and quality of life for people living with haemophilia, which began with the introduction of recombinant therapies and has evolved with the introduction of this once-weekly subcutaneous treatment.”

Earlier this month, Pfizer and Chai Discovery agreed on a licensing deal enabling the former to incorporate Chai’s AI platform into its drug discovery operations.

The post Pfizer’s Hympavzi secures FDA expanded indications for haemophilia appeared first on Pharmaceutical Business review.

India’s pharmaceutical sector is expected to double its current valuation of $60 billion within five years, Union Minister for Commerce and Industry Piyush Goyal said at the curtain raiser ceremony of IPHEX 2026 (International Exhibition of Pharma and Healthcare), organised by Pharmaceuticals Export Promotion Council of India.

Addressing pharmaceutical industry leaders, diplomats and delegates from more than 50 countries, Goyal reaffirmed India’s position as a pharmaceutical manufacturing and export hub and invited global companies to partner with India as investors, innovators and manufacturers.

Goyal said India currently supplies 65–70 per cent of the World Health Organization’s vaccine requirements, hosts the highest number of US FDA-approved manufacturing plants outside the United States, and is home to ten of the world’s top 25 generic pharmaceutical companies. He also pointed to a near 100 per cent increase in patent filings in recent years, the Bio Pharma Shakti programme, and a $10 billion government-backed innovation fund as indicators of India’s shift towards pharmaceutical innovation.

Referring to India’s trade ecosystem, Goyal said the country has Free Trade Agreements covering more than 50 countries and recorded GDP growth of 7.7 per cent for FY2026. “We are looking for partnerships that will last generations,” Goyal said, referring to India’s G20 theme, Vasudhaiva Kutumbakam — The World is One Family.

Speaking about India’s response during the COVID-19 pandemic, Goyal said temporary restrictions on the export of medicines and vaccines were introduced to ensure fair availability at affordable prices and not to restrict access for other countries. He said the government was concerned that traders and financially strong entities could stockpile supplies and sell them at higher prices during the crisis.

Highlighting India’s role in global healthcare, Goyal said the country supplied medicines free of cost to more than 100 countries and ensured that nations seeking pharmaceutical assistance received medicines at pre-COVID prices.

Union Minister of State for Commerce and Industry Jitin Prasada said India offers a stable democratic environment for long-term investment decisions and reiterated the government’s focus on ease of doing business.

“India offers an exceptionally stable democratic environment that enables bold, long-term decisions. Our focus on ease of doing business is absolute and there will be no compromise on quality, safety, and regulatory compliance. I urge global stakeholders to view India not just as a consumer market, but as a trusted manufacturing and co-creation partner,” he said.

Prasada also highlighted the recently passed Jan Vishwas Bill, describing it as a step towards reducing compliance burdens and creating a transparent business environment.

Rajesh Agrawal, Commerce Secretary, Ministry of Commerce and Industry, described India as the “Pharmacy of the World”, noting that the country produces more than 60 per cent of global generic medicines across 60 therapeutic areas and exports to more than 200 countries.

He said the industry should move from responding to global regulatory changes to taking a leadership role in shaping them. Agrawal also outlined the government’s intention to use Production Linked Incentive (PLI) schemes to support areas such as biopharma and expressed a vision of developing IPHEX into one of the world’s largest healthcare ecosystems.

Namit Joshi said, “Indian pharmaceutical companies are expanding well beyond traditional markets, building a strong presence across emerging geographies while reinforcing their foothold in regulated markets. With over 3,000 companies, more than 10,500 manufacturing units and a presence in over 150 countries, the industry is ready to be a long-term partner in global health. The Global Ambassadors Meet aligns diplomatic goodwill with industry capability and sets the stage for iPHEX 2026 and the GDRC 2026.”

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Immuneel Therapeutics has announced the successful closure of its Series B funding round, raising more than ₹100 crore. The round saw participation from new investors including Singularity AMC, Rainmatter by Zerodha and several high-net-worth individuals, alongside continued participation from existing investors including Kiran Mazumdar-Shaw, Eight Roads Ventures and F-Prime Capital.

The company stated that the funding will be used to scale its GMP manufacturing capacity, advance its cell and gene therapy pipeline towards clinical milestones, support the commercialisation of Qartemi, and accelerate expansion into markets across Asia Pacific and the Middle East.

Following the commercial launch of Qartemi, a CAR-T therapy approved for Non-Hodgkin Lymphoma, Immuneel is extending its presence in emerging markets and progressing clinical co-development partnerships in Australia and Southeast Asia. The company operates a CAR-T platform in India aimed at delivering cell therapies at lower costs compared to Western markets.

Commenting on the development, Kiran Mazumdar-Shaw, Founder of Immuneel Therapeutics, said: “This company was founded with the belief that advanced cell therapies should not remain confined to a small segment of patients or a handful of geographies. This fundraise strengthens our ability to build a globally competitive CAR-T platform from India combining deep science, scalable manufacturing and significantly improved affordability. We believe India can play a meaningful role in shaping the future of cell and gene therapy for the world.”

Amit Mookim, Chief Executive Officer of Immuneel Therapeutics, added, “Qartemi’s commercialisation proved we can deliver world-class CAR-T outcomes at a fraction of Western costs. This Series B financing accelerates what comes next: a bold international expansion and a next-generation pipeline that will redefine how cell therapies reach patients globally. We are not just building a company—we are building a new global standard of care, from India.”

Aravind Viswanathan, Senior Operating Partner at Singularity AMC, said, “CAR-T cell therapy represents one of the most consequential breakthroughs in modern oncology—the ability to engineer a patient’s own immune cells to precisely target and eliminate cancer is a paradigm shift that was, until recently, accessible only to patients in the wealthiest corners of the world. Immuneel is changing that. What excites us most is the breadth of their pipeline: from expanding into new blood cancer indications to next generation modalities that could dramatically reduce the cost and complexity of treatment. Each of these advances has the potential to extend lifesaving therapy to tens of thousands of patients in India and beyond, who currently have no access to it. We are proud to partner with this world-class team as they disrupt the market and scale their premium-outcome therapeutics globally.”

Nithin Kamath, Founder and CEO of Zerodha and Rainmatter, commented, “Cancer remains one of the most devastating diseases of our time and the most advanced treatments have been out of reach for most Indians. We’re living a moment where biotech innovations are genuinely changing what’s possible and we’re excited to support Immuneel who are bringing Cell and gene therapies, including CAR-T to Indian patients with a focus on outcomes and accessibility. We believe in supporting innovations that create deep, long-term societal impact. Immuneel’s mission to bridge the accessibility gap for lifesaving cell and gene therapies aligns perfectly with our vision, and we are excited to back their journey towards equitable healthcare and global expansion.”

The company said the financing will support its manufacturing expansion, clinical development programmes, commercial activities and international market entry plans.

The post Immuneel raises ₹100 crore in Series B funding to expand CAR-T therapy operations and global presence appeared first on Express Pharma.

Building on the earlier Express Pharma article, “Enhancing Visibility, Predictability and Transparency in IP Procedures” (July 23, 2025), this article examines how India’s InPASS and IP India portal compare with global patent search platforms such as WIPO PATENTSCOPE, the USPTO Patent Center and the European Patent Office’s Espacenet. It analyses differences in administrative and procedural timeline tracking, prosecution-event data and data-export capabilities, while outlining an ideal search-module architecture to support systematic delay analysis and large-scale extraction of application data. The article also identifies key beneficiary groups and argues that effective utilisation of national patent databases is critical to sustaining innovation, policy development and long-term national progress. 

While India has moved far beyond the IPAIRS era, it is in a prime position for growth and to match and then surpass these global systems in structured, machine-readable event-handling and analytical capabilities.

1. Comparative features table: India vs WIPO / USPTO / Espacenet

Below Table 1 summarizes how India’s InPASS / IP India compares with WIPO PATENTSCOPE, USPTO Patent Center / Public PAIR, and Espacenet (EPO-based) / E-register along key axes of bibliographic coverage, legal-event / procedural-step data, delay-measurement support, and exportability/APIs.

Table 1: Administrative-procedural and event-data coverage

This table highlights three main gaps for India:

• No standardized, searchable event-type codes tied to clear dates;
• No built-in pendency / delay-calculation module;
• No export-ready or API-style access to event-augmented bibliographic data.

2. Exports of hits and practical usability for delay analysis
3. a) India (InPASS / IP India)

Under InPASS, bibliographic searching (title, applicant, IPC, etc.) yields a hit-list, but there is no direct export button to CSV/JSON/xls/doc for the full record set. This means:

• To study delays, one must open each hit individually and either read the pipeline-diagram text (Filed, Published, RQ-Filed, Under Examination, Disposed) or inspect “View Documents” to manually note event-dates.

This has serious consequences for administrative-delay analysis:

• Large-scale, quantitative pendency studies (e.g., “median time from filing to FER by technology class”) are practically infeasible directly from the India-only portal;
• Firms and universities typically resort to screen-scraping or rely on third-party tools (e.g., Lens, commercial analytics platforms) that ingest India-data via other channels.

1. b) WIPO PATENTSCOPE

WIPO PATENTSCOPE allows export of search results in XML-based formats suitable for batch-processing, and provides web services / links/ drawings, figures [for Active pharmaceutical ingredients and formulations (APIs)] and Application Programming Interface (also referred as API in computer related field) for families and bibliographic data. However, legal-event data for India are only as good as India’s own feed to WIPO; WIPO does not currently enrich India’s procedural-event data beyond what the IPO transmits.

For India-focused delay-studies, this implies:

• One still needs to cross-check InPASS for detailed event-dates and pipelines, because WIPO’s view is largely bibliographic-plus-family-oriented rather than event-rich.

1. c) USPTO Patent Center / Public PAIR

USPTO’s Patent Center and Public PAIR provide hit-lists and per-application transaction-history (with clear event-types and dates). Through the USPTO Open Data Portal and Application Programming Interfaces (APIs), developers can obtain structured data on:

• Filing dates, first-action-dates, allowance-dates, issue-dates, appeals, extensions, fee-payments, and office-action-types.

The impact on delay-analysis is substantial:

• US-based researchers and firms can build custom pendency dashboards (e.g., median time from filing to first office action by tech-class) directly from standardized, exportable data;
• This represents a clear advantage over India, where similar analyses require manual per-case data-gathering.

1. d) Espacenet / E-register

Espacenet lets users type a search term and export/download the hit list in Excel, first-page PDF, or CSV formats. Advanced search and filtering support “save list”-like behavior for bibliographic hits, but the richest legal-event data are accessed via EPO-OPS (web services) and PATSTAT (commercial analytical database).

For pendency-analysis, this combination enables:

• Fetching all patents in a class and computing average pendency;
• Measuring how long applications stay in each status (e.g., “under examination”);
• Cross-comparing timelines between jurisdictions (US vs Europe vs family-members).

In contrast, India’s InPASS currently offers no equivalent of OPS or PATSTAT-style analytical backbone, leaving India-only delay-analytics at a disadvantage.

3. What an “ideal” patent-office search module should provide

An ideal patent-office search module (e.g., next-generation InPASS) should allow users to search, visualize timelines, and export both substantive and procedural data so that administrative-procedural delays and event-sequences can be systematically measured and shared with higher-level stakeholders. It can be done for a singular find or for a clustered command when software is designed based on this required logic. The following is a structured feature-wish-list that can be folded into a formal requirement document for the Indian Patent Office.

1. Core search-level features for delays and events

1. Event-tag and status-code search fields

Expose standardized event-type codes, such as:
FILING, PUBLISHED, RQ_EXAM_FILED, FER_ISSUED, REPLY_FILED, HEARING_SCHEDULED, GRANT, REFUSE, OPPOSE, OPPOSITION_BOARD_CONSTITUTED, OPPOSITION_HEARD, OPPOSITION_DECISION, LAPSE, FEE_PAID, APPEAL_FILED, REVIEW_GRANTED, LICENSED, ASSIGNED.

Let users filter search results by:

• “Has event-type = FER_ISSUED and no GRANT within 36 months of filing”;
• “Has LAPSE event within 5 years of grant”;
• “No event-type = EXAM_COMMUNICATION in the last 24 months”.

• These event-codes should be internally stored in the mainframe, relatable, and exportable in the chosen format (CSV/JSON).

1. Event-date search and pendency filters

Allow Boolean-style filters on event-dates:

• “FER_ISSUED after 2023-01-01”;
• “Time between FILING and FER_ISSUED > 30 months”;
• “Time between FER_ISSUED and GRANT > 24 months”.

• Provide sliders for “Filing-to-First-Office-Action delay”, “Filing-to-Grant pendency”, “Replication-to-Decision delay in opposition”, etc., computed from the underlying event-dates.

1. Status-timeline visualization per hit

Alongside each hit-list item, show a compact, interactive timeline (akin to WIPO family-timelines or Espacenet legal-events tabs) displaying:
Filing → Publication → Request-for-Examination → FER → Reply-to-FER → Hearing → Grant/Refusal → Opposition → Renewal-payments → Lapse / Renewed.

Each event-dot should be clickable to open the relevant document or order.

1. Per-office pendency-dashboard widgets (for India)

Embed mini-panels showing:

• Average “Filing-to-FER” time by filing-office (Delhi, Mumbai, Chennai, Kolkata);
• Average “FER-to-Grant” time by technology-class (IPC/CPC);
• % of applications that lapse before grant or within 5/10 years of grant.

• These statistics should be computed from the same event-data used by the search engine, ensuring consistency.

A committee or a bench may be constituted comprising of users from practitioners and Industry along with Patent office executives to design a better set of Core search-level features for delays and events with an objective of providing features as may ne suggested. 

1. Data-model and export-oriented features

1. Structured, machine-readable event-data model

Internally, each application should have an event-array, for example:

json

“events”: [   {“type”: “FILING”, “date”: “2022-03-15”},

  {“type”: “PUBLISHED”, “date”: “2023-09-12”},

  {“type”: “RQ_EXAM_FILED”, “date”: “2023-10-05”},

  {“type”: “FER_ISSUED”, “date”: “2025-01-20”},

  {“type”: “REPLY_FILED”, “date”: “2025-03-10”},

  {“type”: “HEARING_SCHEDULED”, “date”: “2025-04-15”},

  {“type”: “GRANT”, “date”: “2025-07-01”},

  {“type”: “FEE_PAID”, “date”: “2026-06-30”}  ]

This model should power the UI timelines [a visual component used in apps and websites to display a sequence of events, tasks, or milestones in chronological order] and pendency-calculations and be exposed via an API [Application Programming Interface] for analytics-tool integration.

1. Export of hit-lists with event-data
   • When running a search (e.g., “all pharmaceutical-patents where FER was issued more than 36 months after filing”), the system should let users export a CSV / JSON file containing:
     • Bibliographic data (app-number, title, applicants, inventors, IPC, filing-date, publ-date, grant-date, etc.);
     • Event-list as above, plus derived fields such as delay_filing_to_fer, delay_fer_to_grant, status_current, last_event_date.

This would enable universities, law-firms, and policymakers to:

• Compute pendency statistics;
• Identify “procedural bottlenecks” (e.g., long-lived “Under-Examination” cases);
• Map how delays vary by technology-class or filing-office.

1. Open-data / API-style access

Provide public-REST APIs allowing authorized users to query:

• “All applications in IPC-A61K with FER_ISSUED between 2020 and [current year]” or such type of query;
• “All cases with LAPSE within 5 years of GRANT in a given class” or such type of query.

1. Updating status of appealed/remanded/reviewed/granted or refused remanded cases
   • When a refusal to grant is appealed before a High Court, the Patent Status should clearly indicate “Appeal pending before High Court”, because the prosecution has not reached its logical conclusion unless the application is expressly abandoned or the refusal is not appealed.
   • If the High Court remands the matter back to the Patent Office for fresh review, the status should show: “Remanded back to Patent Office for review” and or “Remanded patent application is under review”;

Above suggestions and logic is indicative. A better website can be designed after due contribution from users mainly attorneys, industry and the office executives with an objective to provide better information for the betterment of India. 

• Replacing “complete specification” by “claims” and “other parts of specification”. 

It prunes the hit list to more relevant ones.

Stakeholders Benefiting from Enhanced Patent Search Facilities

Improved patent-search facilities at the India Patent Office, including better substantive search fields, richer event data, timelines, and export capabilities, primarily benefit data-driven users while offering limited gains to others.

These enhancements enable precise freedom-to-operate assessments, pendency predictions, and strategic planning for key groups.

Primary Beneficiaries

• Patent applicants, SMEs, and startups: Gain insights into freedom-to-operate, pendency timelines, and bottlenecks, allowing accurate R&D planning, product launches and avoidance costly filings of slow-system filings. 
• Law firms and IP professionals: Enable bulk analysis, prosecution benchmarking, and improved client counseling through structured exports and event data.
• Universities and research institutions: Support thematic landscape studies, policy justifications, and academic research, improve innovation efficiency by reducing time of prior research and prior art search.
• Patent examiners and IPO administration: Facilitate workload optimization, bottleneck detection, and performance dashboards for staffing and efficiency improvement decisions.

• Policymakers and regulators: Provide evidence for reforms, delay measurements, and impact evaluations of prior initiatives and evaluation of impact of existing reforms on timelines. This leads to designing more evidence-based IP-policy rather than impression-based decisions.

• International stakeholders: Allow integration of Indian data into global databases, enhancing cross-jurisdictional comparisons and investment appeal enabling cross-border tech-transfer.

These are important contributors to Indian industry and its progress, to enhance Indian capabilities, to enable India into new industrial arena, to the economy and future.

Marginal or No Beneficiaries

Certain users derive little value due to limited engagement with advanced features.

• Non-data-driven applicants: Sole inventors or traditional-industry filers who avoid detailed tracking see minimal practical gains.
• Non-digital-native users: Those uncomfortable with Boolean searches or exports may find features over-engineered.

Groups Facing Relative Disadvantages

Transparency reduces advantages for opacity-dependent actors.

• Information asymmetry intermediaries: Lose leverage as applicants access clear timelines independently.
• Delay-reliant entities: Tactics like procedural obstruction become visible and politically costly, particularly in pharmaceuticals.
• Low-efficiency operators: Experience pressure to improve amid higher performance standards and learning curves.
  • Patent-profiling or “patent-thick-cloud” firms that rely on blind-filing: Companies that file many low-quality or overly-broad patents without robust prior-art searches will:
• • Face stronger opposition once search becomes easier and prosecution-timelines more visible.
  • Risk higher rates of refusal or narrow-claims when examiners and third parties have better prior-art access.
• Their tactical-patent-strategy becomes less effective, while the system as a whole becomes healthier.

Table 2: Summary table: “Will benefit” vs “Will not benefit”

Stakeholder group	Likely beneficiary?	Reason (short)
Inventors, SMEs, start-ups	Strongly	Better FTO, pendency insight, cost-saving in filing strategy.
IP law firms / practitioners	Strongly	Bulk analytics, timeline-benchmarking, client-advice, process-improvement.
Universities / public R&D centers	Strongly	Thematic-landscape studies, policy-support, innovation-monitoring.
Patent examiners & IPO management	Strongly	Work-load-balancing, bottleneck-detection, performance-monitoring.
Policymakers and regulators	Strongly	Evidence-based reform, cross-jurisdictional benchmarking.
International firms and analytics platforms	Strongly	Richer India-data for global-landscape studies and services.
Non-digital-sophisticated applicants / agents	Weakly / none	May not use advanced features; UX must stay simple.
Information-asymmetry-based intermediaries	Loser (relative)	Reduced scope to exploit opaque timelines and filings.
Entities using delay-or obstruction-tactics	Loser (relative)	Tactics become more visible and politically risky.
Low-efficiency operators in the system	Loser (relative)	Face higher pressure to improve speed and quality.

Conclusion

 In the knowledge economy, intellectual property rights—particularly patents—drive industrial advancement, facilitate the internalization of enhanced technologies, and deliver broad national benefits. Prioritizing, promoting, and continually enhancing the capabilities for mapping, searching, and leveraging national patent databases is therefore essential for sustained national progress.

The post India patent office can bridge the gap with global patent search platforms appeared first on Express Pharma.

Eli Lilly and Company has announced detailed results from three Phase 3 trials in the ACHIEVE programme evaluating orforglipron, a small molecule oral GLP-1, in adults with type 2 diabetes. According to the company, the therapy is taken without food or water restrictions.

In the ACHIEVE-3 trial, orforglipron outperformed oral semaglutide across the primary endpoint and all key secondary endpoints. In ACHIEVE-2 and ACHIEVE-5, orforglipron met the primary endpoint and key secondary endpoints, delivering A1C reduction and weight loss compared with dapagliflozin and placebo added to insulin glargine, respectively. Results from ACHIEVE-3, ACHIEVE-2 and ACHIEVE-5 were presented at the American Diabetes Association (ADA) 86th Scientific Sessions. ACHIEVE-3 was published in The Lancet, while ACHIEVE-2 and ACHIEVE-5 were published in The Lancet and JAMA, respectively.

“ACHIEVE-3 provides the first head-to-head data on oral GLP-1s in type 2 diabetes, with orforglipron showing greater A1C and weight reductions than oral semaglutide, which was tested at approved diabetes doses,” said Dr. Julio Rosenstock, clinical professor of medicine at the University of Texas Southwestern Medical Center and ACHIEVE-3 lead investigator. “That level of efficacy is reinforced in ACHIEVE-2 and ACHIEVE-5, demonstrating a consistent and robust treatment effect across a wide spectrum of patient populations. These results support a potential shift toward using oral GLP-1 receptor agonist therapies like orforglipron earlier as a foundation of type 2 diabetes care.”

According to Lilly, ACHIEVE-3 compared orforglipron 9 mg and 17.2 mg with oral semaglutide 7 mg and 14 mg in a Phase 3 head-to-head trial of two oral GLP-1 receptor agonists for type 2 diabetes. At 52 weeks, orforglipron lowered A1C by an average of 1.9 per cent (9 mg) and 2.2 per cent (17.2 mg), compared with 1.1 per cent (7 mg) and 1.4 per cent (14 mg) for oral semaglutide. Lilly stated that this represented a 57.1 per cent greater relative reduction at the highest dose comparison.

The company also reported that 37.1 per cent of patients receiving the highest dose of orforglipron achieved an A1C level below 5.7 per cent, compared with 12.5 per cent of patients receiving the highest dose of oral semaglutide. Weight loss averaged 6.6 kg (6.7 per cent; 9 mg) and 8.9 kg (9.2 per cent; 17.2 mg) with orforglipron, compared with 3.6 kg (3.7 per cent; 7 mg) and 5.0 kg (5.3 per cent; 14 mg) with oral semaglutide. Lilly reported a 73.6 per cent greater relative weight loss at the highest dose comparison.

In ACHIEVE-2, orforglipron reduced A1C by up to an average of 1.7 per cent at 40 weeks from a baseline of 8.1 per cent, compared with 0.8 per cent for dapagliflozin. Up to 68.6 per cent of patients receiving the highest dose of orforglipron achieved an A1C level of 6.5 per cent or below, compared with 21.6 per cent for dapagliflozin.

Patients receiving orforglipron lost an average of 3.2 kg (3.5 per cent; 2.5 mg), 5.8 kg (6.3 per cent; 9 mg) and 6.8 kg (7.3 per cent; 17.2 mg), compared with 2.7 kg (3.0 per cent) for dapagliflozin.

In ACHIEVE-5, which evaluated orforglipron alongside titrated insulin glargine, the therapy reduced A1C by up to an average of 2.1 per cent at 40 weeks from a baseline of 8.5 per cent, compared with 0.8 per cent for placebo. Up to 69.1 per cent of patients receiving orforglipron 9 mg achieved an A1C level of 6.5 per cent or below, compared with 11.1 per cent for placebo.

Participants receiving orforglipron lost an average of 2.2 kg (2.7 per cent; 2.5 mg), 5.0 kg (5.8 per cent; 9 mg) and 5.2 kg (6.1 per cent; 17.2 mg), compared with a 0.5 kg (0.6 per cent) weight gain in the placebo group.

“When we look across the ACHIEVE program, orforglipron consistently demonstrated superior A1C control and weight loss, giving us real confidence in what it could deliver for patients,” said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. “ACHIEVE-3 marks the first time two oral GLP-1 therapies have been tested head-to-head in a Phase 3 study, and orforglipron clearly outperformed oral semaglutide on the outcomes that matter most to patients with type 2 diabetes. For the millions of people with type 2 diabetes who want an oral treatment they can take any time of day, orforglipron has the potential to be an attractive first-line therapy option in primary care.”

Lilly stated that across all three trials, orforglipron demonstrated improvements from baseline in cardiovascular risk factors including non-HDL cholesterol, HDL cholesterol, VLDL cholesterol, total cholesterol, systolic blood pressure and triglycerides.

The company reported that the safety and tolerability profile of orforglipron, including treatment discontinuation rates, was consistent with previous studies. The most common adverse events across the three studies were gastrointestinal, including nausea, diarrhoea, vomiting, dyspepsia and decreased appetite.

Treatment discontinuation rates due to adverse events in ACHIEVE-3 were 8.7 per cent and 9.7 per cent with orforglipron 9 mg and 17.2 mg, respectively, compared with 4.5 per cent and 4.9 per cent for oral semaglutide. In ACHIEVE-2, discontinuation rates were 9.2 per cent, 10.8 per cent and 12.4 per cent for orforglipron 2.5 mg, 9 mg and 17.2 mg, respectively, compared with 1.2 per cent for dapagliflozin. In ACHIEVE-5, discontinuation rates were 3.6 per cent, 7.6 per cent and 9.6 per cent for orforglipron 2.5 mg, 9 mg and 17.2 mg, respectively, compared with 3.6 per cent for placebo.

Lilly said that based on findings from ACHIEVE-1, ACHIEVE-3, ACHIEVE-2, ACHIEVE-4 and ACHIEVE-5, it plans to submit orforglipron for the treatment of type 2 diabetes to the US FDA by the end of the second quarter under the Commissioner’s National Priority Review Voucher.

The post Lilly’s orforglipron outperforms oral semaglutide in Phase 3 diabetes trial appeared first on Express Pharma.

The pharma industry recorded a 156.8 per cent increase in deal value in May 2026 compared to May 2025, according to GlobalData.

In May 2026, the healthcare industry reported 68 deals valued at $18.5 billion. This compares with the average of 84 deals worth $26.4 billion recorded over the previous 12 months, from May 2025 to April 2026.

Among the largest transactions announced during the month was the acquisition of all outstanding shares of Catalyst Pharmaceuticals, Inc. by Angelini Pharma S.p.A. for an enterprise value of $4.8 billion. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing medicines for patients living with rare and difficult-to-treat diseases.

Another major transaction involved Bayer AG, which agreed to acquire Perfuse Therapeutics for up to $2.45 billion. Perfuse Therapeutics focuses on research into treatments for ischemia-induced ocular diseases.

The third-largest deal reported during May 2026 was the acquisition of Candid Therapeutics by UCB for up to $2.2 billion. Candid Therapeutics is a privately held clinical-stage biotechnology company focused on autoimmune and inflammatory diseases through T-cell engager therapies.

GlobalData also reported a decline in venture capital activity during the month. Venture capital funding in the healthcare industry fell by 21.5 per cent in May 2026 compared to May 2025.

The healthcare sector recorded 90 venture capital deals worth $2.02 billion in May 2026. This compares with the average of 112 deals worth $3 billion recorded over the previous 12 months, from May 2025 to April 2026.

Among the largest venture capital transactions was a $220 million Series D financing round raised by CellCentric. The funding will support the advancement of inobrodib through clinical development studies, including continued enrolment in the company’s Phase II DOMMINO-1 study.

cAMPfield Therapeutics Inc raised $180 million in a Series A financing round. The US-based company focuses on developing therapies targeting the cyclic adenosine monophosphate (cAMP) signalling pathway.

Meanwhile, Windward Bio AG secured $165 million in financing to advance a thymic stromal lymphopoietin (TSLP) monoclonal antibody into Phase II development. The company is focused on therapies for immunological diseases.

The post Pharma deal value rises 156.8% in May 2026: GlobalData appeared first on Express Pharma.

Twelve years is an important milestone in the life of a nation. As India reflects on more than a decade of sweeping transformation under the leadership of Hon. Prime Minister Shri Narendra Modi ji, it is tempting to look at healthcare progress purely through the lens of scale.

The numbers are undeniable: millions of families are now protected by Ayushman Bharat PM-JAY, nearly 18,000 Jan Aushadhi Kendras provide affordable care (a staggering leap from just 80 stores in 2014), and the CoWIN digital platform successfully powered one of the largest vaccination drives in human history.

But scale is only part of the story. The true transformation of Indian healthcare isn’t just about expanding an existing system; it is about a fundamental structural shift. We have successfully moved from a state of crisis management to one of deep-rooted systemic resilience. As we look toward the next decade, our shared responsibility is to transition from basic access to an ecosystem driven by world-class innovation.

Rewriting the social contract: Access and affordability

For decades, Indian healthcare was defined by crippling out-of-pocket expenses that could push vulnerable families into poverty overnight. Overturning this reality required a complete rethinking of primary and tertiary care delivery models, a vision heavily anchored by the National Health Policy 2017.

The launch of Ayushman Bharat completely changed this social contract, offering a robust financial safety net to millions of our most vulnerable citizens. However, insurance is only effective if care is physically within reach. By anchoring this system with a vast network of over 1.82 lakh Ayushman Arogya Mandirs across the country, we have brought preventive, promotive, and primary healthcare directly to the doorsteps of local communities.
At the grassroots level, the rapid expansion of Jan Aushadhi Kendras has ensured that daily, life-saving medications are no longer a luxury. This local accessibility is backed by major macro-infrastructure growth. The rapid establishment of new AIIMS institutions, expanding medical education, and targeted funding from the PM Ayushman Bharat Health Infrastructure Mission have significantly enhanced our national health preparedness, disease surveillance, and critical care laboratory networks.

From volume to value: The era of self-reliance and innovation

No amount of policy planning could fully prepare the world for the COVID-19 pandemic, yet it became the ultimate test of India’s healthcare architecture. The crisis demanded an unprecedented level of real-time collaboration among the government, private industry, healthcare professionals, scientists, and local communities.

We didn’t just scale up infrastructure under pressure; we mass-produced vaccines for the world. Through the Vaccine Maitri initiative, India supplied nearly 300 million vaccine doses to less developed and vulnerable nations—solidifying our reputation as a trusted global healthcare partner.

However, a truly self-reliant nation cannot rely solely on manufacturing scale. The defining turning point of the past decade has been our evolution from a producer of low-cost generics to a leader in high-value biopharmaceuticals.

The government’s PLI Schemes for bulk drugs and pharmaceuticals, alongside the PLI for Medical Devices and the Bulk Drug Parks initiative, have been major catalysts. By incentivising the domestic production of essential KSMs and APIs, we have steadily reduced our import reliance and fortified our national health security.

Yet, manufacturing power must be matched by intellectual leadership. To transition India from a manufacturing hub into a global research and development engine, the PRIP scheme, launched in 2023, with an approved outlay of INR 5000 crores and the recently announced BioPharma Shakti programme, with an approved outlay of INR 10,000 crores, have marked a pivotal shift.

Furthermore, the government’s recent Union Budget commitment to strengthen our network of seven NIPER institutions as Centres of Excellence ensures we are actively nurturing scientific talent and fostering vital industry-academia links in precision medicine, medical devices, and targeted therapies.

A conducive regulatory horizon

This shift toward deep technology and original innovation is backed by a quiet regulatory revolution. The implementation of the NDCT rules, 2019 streamlined approval processes and minimised bureaucratic red tape. This has made India an increasingly attractive, predictable, and competitive destination for global clinical research, allowing Indian patients earlier access to cutting-edge therapies.

This modernisation is an absolute necessity. India is currently navigating a complex health transition, marked by a heavy burden of non-communicable diseases, an aging demographic, and rising demand for advanced specialised care.

Furthermore, recent fiscal measures—such as customs duty rationalisation and targeted import duty reductions on critical cancer medicines, life-saving therapies, and medical devices—have directly eased the financial burden on families fighting serious illnesses. This ensures that global breakthroughs in oncology, immunology, and precision medicine are not just theoretically possible in India, but practically accessible.

The roadmap for the next decade

As we look ahead, India’s expanding network of FTAs and economic partnerships—including recent agreements with the UAE, Australia, Mauritius, the UK, New Zealand, Oman, and the European Free Trade Association countries (Switzerland, Norway, Iceland, and Liechtenstein)—will further integrate our healthcare ecosystem into global value chains, attracting investment and driving technology transfer.

To sustain this momentum, our strategic priorities for the next decade must center on five areas:

Strengthening Innovation: Build on PLI, PRIP, and FTA frameworks to enhance clinical research and IP protections, positioning India as a hub for medical innovation. Building a robust ecosystem around IP will require introducing RDP to recognise and value the innovation and increase the investment in the sector.

Faster Patient Access: Streamline regulatory and commercial pathways to ensure timely access to new treatments. This will help the Indian patient get a faster access to drugs when they are launched parallelly in India as globally.

Advancing Digital Health: Continue accelerating the Ayushman Bharat Digital Mission to create an integrated, data-driven healthcare ecosystem.

Focusing on Outcomes: Measure success through better patient outcomes, earlier diagnoses, improved quality of life, and healthier communities—not just healthcare volumes.

Moving forward, the goal is clear: India must not only remain the Pharmacy of the World. We must become the Healthcare Innovation Hub of the World—a place where scientific excellence, equitable access, and deeply human, patient-centered care come together to improve and save lives globally.

As OPPI celebrates 60 years of bringing innovative therapies and putting patients at the core of all decision making, we continue our collaboration with the Government under the able guidance of our Hon. Union Minister for Health and Family Welfare, Shri Jagat Prakash Nadda-ji. We remain committed towards increasing access to innovation, and achieve the transformative vision set by Hon PM Shri Narendra Modi ji of Viksit Bharat 2047.

The post How India reimagined healthcare in 12 years—and what comes next appeared first on Express Pharma.

Aqneursa is approved across the EU for adults and children aged six years and above who weigh at least 20kg.

The authorisation covers the combined use with miglustat or as a single therapy if miglustat cannot be tolerated.

IntraBio CEO Mallory Factor said: “This approval represents a significant milestone for the NPC community in Europe. We are grateful to the EMA and European Commission for their thorough review and for recognising the clinical value of Aqneursa.

“This decision reflects years of breakthrough scientific work and collaboration with clinicians and patient organisations, and it marks an important step toward expanding access to this therapy for people living with NPC.”

The approval is supported by data from a Phase III randomised, double-blind, placebo-controlled, crossover study in NPC patients.

Results from the study indicated that treatment with Aqneursa provided a statistically significant and clinically important improvement in neurological symptoms and function after 12 weeks.

These improvements were measured by the Scale for the Assessment and Rating of Ataxia and compared with placebo.

In the ongoing open-label extension phase, improvements sustained after the initial 12-week treatment period continued to be observed, reflecting a consistent neuroprotective effect over time.

Observational comparisons with a natural history control group demonstrated that treatment with Aqneursa was linked to an 118% reduction in annual disease progression at one year.

A similar effect was maintained at two years, according to the 5-domain NPC Clinical Severity Scale.

Aqneursa is available as 1g granules for oral suspension. The active ingredient, levacetylleucine, is a modified amino acid targeted at correcting metabolic dysfunction and improving cellular energy in the central nervous system.

The therapy received orphan medicinal product status during its development and is also indicated for similar uses in the US, and has flatulence as its most frequently reported side effect.

The post EC grants marketing authorisation for IntraBio’s Aqneursa appeared first on Pharmaceutical Business review.

Since 2021, Sanofi and Owkin have maintained a €90m ($103.6m) collaboration focused on oncology target identification and patient subgrouping.

The scope later expanded to drug positioning within Sanofi’s immunology pipeline. This latest phase marks the evolution of their joint efforts towards comprehensive AI integration in biopharma.

Owkin will oversee the end-to-end construction of new agentic AI tools, specifically tailored for Sanofi’s needs.

Functioning as intelligent digital assistants, these agents aim to autonomously undertake complex work in drug research and development processes.

Deployed through K Pro, these agents will supplement and strengthen Sanofi’s existing AI infrastructure.

K Pro fuses multimodal patient datasets with dedicated biological AI systems to support pharmaceutical workflows from early-stage discovery to clinical development.

The platform aims to enhance competitive intelligence, support faster and more informed decision-making, and improve accuracy across the industry value chain.

Owkin CEO and co-founder Thomas Clozel said: “Building on our collaboration with Sanofi, this marks a shift toward truly embedded AI.

“Owkin believes that, with K Pro, Sanofi can further harness agentic systems within their own workflows, unlocking the full value of their data to accelerate better decisions across drug development.”

Sanofi chief digital officer Emmanuel Frenehard said: “Across Sanofi, we are continually investing in frontier AI solutions with the potential to accelerate and improve decision-making throughout the drug development life cycle.

“By implementing purpose-built agentic systems into our workflows, we aim to empower our teams to operate with greater speed, depth, and confidence as we continue to work to deliver transformative outcomes for patients.”

K Pro’s ongoing development supports Owkin’s goal of achieving biological artificial superintelligence to transform pharmaceutical research and development by addressing previously unsolved challenges and driving future drug discoveries.

Last month, Sanofi received a priority review from the US Food and Drug Administration for its new drug application for venglustat, an oral glucosylceramide synthase inhibitor (GCSi) intended for the treatment of type 3 Gaucher disease (GD3).

The post Sanofi and Owkin partner to develop next-generation biopharma AI agents appeared first on Pharmaceutical Business review.

Global pharma major Lupin announced its strategic collaboration with LABORATORIOS ERN S.A. (ERN), a well‑established Spanish pharmaceutical company, for the launch of Luforbec (beclometasone/formoterol) 100/6, a fixed dose combination in a pressurised metered dose inhaler, for the treatment of adult asthma and chronic obstructive pulmonary disease, in Spain.

This collaboration combines Lupin’s global respiratory expertise and proven pMDI manufacturing excellence and ERN’s robust national reach and deep customer relationships, marking an exciting milestone in expanding high‑quality respiratory care to patients across Spain.

Thierry Volle, President EMEA and Emerging Markets, Lupin said, “The launch of Luforbec in Spain, following successful introductions in the UK and Germany, represents a key milestone in our partnership with ERN and reinforces our commitment to advancing global access to quality respiratory care. Together, we are building something truly exciting for patients and healthcare professionals.”

“Partnering with Lupin allows us to bring a proven, high‑value respiratory therapy to Spanish patients and healthcare professionals. It represents an opportunity for ERN to expand into a new therapeutic area,” said David Solanes, CEO of LABORATORIOS ERN, S.A.

The post Lupin collaborates with ERN for Luforbec pMDI launch in Spain appeared first on Express Pharma.

CBC India has announced an exclusive partnership between its Ingredients &  Packaging Solutions (IPS) Division and Metalco-Alupack, a leading European manufacturer  of pharmaceutical aluminium packaging solutions. 

This partnership represents a significant milestone in journey, reinforcing CBC India’s commitment to supporting the pharmaceutical industry with high-quality, reliable ingredients and packaging solutions, while driving market development and distribution of Metalco Alupack products across India. 

Metalco-Alupack specializes in the production of seamless anodized aluminium containers for  chemical and pharmaceutical products, particularly sterile APIs. Known for its superior  European quality and strong regulatory support, Metalco-Alupack has established itself as a  trusted partner for pharmaceutical manufacturers worldwide. 

Mario Bartolomei, Managing Director, Metalco-Alupack stated: “We are pleased to partner  with CBC India as we expand our presence in the Indian pharmaceutical market. CBC India’s  strong industry expertise, extensive market reach and commitment to customer success make  them an ideal partner for Metalco-Alupack. Together, we look forward to delivering high-quality  pharmaceutical aluminium packaging solutions that support product integrity, regulatory  compliance and patient safety.” 

Durgesh Sharma, Managing Director, CBC India commented: “At CBC India, strong  partnerships are at the heart of everything we do. We are excited to join hands with Metalco Alupack and aim to unlock new opportunities by combining Metalco-Alupack’s century-long  expertise in aluminium processing and pharmaceutical packaging to create sustainable growth together and deliver trusted pharmaceutical packaging solutions across India.” 

The post CBC India and Metalco-Alupack sign exclusive strategic partnership appeared first on Express Pharma.

Maiva Pharma, a leading global Contract Manufacturing Organization (CMO) and Contract Development and Manufacturing Organization (CDMO) specialising in sterile injectables inaugurated its new manufacturing facility at Shoolagiri, Tamil Nadu, India.

The facility marks a significant milestone in Maiva’s growth journey, further strengthening its position as a trusted partner to global pharmaceutical and biotechnology companies for the development and manufacturing of generic and complex sterile injectable products.

Spread across a 22-acre site, the new facility has been designed to support current and future market requirements through advanced manufacturing technologies, flexible production capabilities, and world-class quality systems. Upon full development, the facility will house six manufacturing lines capable of producing a broad range of sterile injectable dosage forms, including vials, pre-filled syringes (PFS), cartridges, suspension products, and lyophilized formulations.

As part of the Phase 1 expansion, Maiva Pharma has commissioned three dedicated manufacturing lines comprising a high-speed vial filling line, a combined pre-filled syringe and cartridge line, and a lyophilization line. The facility is further supported by advanced Quality Control chemical laboratories and state-of-the-art Microbiology laboratories, enabling comprehensive analytical testing and quality assurance functions in-house.

A key highlight of the facility is its advanced isolator-based manufacturing lines for liquid vials, pre-filled syringes, cartridges, and lyophilized vials.  The isolator technology enhances sterility assurance, operational efficiency, and manufacturing flexibility while supporting the production of a wide range of injectable products for regulated global markets.

Commenting on the inauguration, Dr. Bhaskar Krishna, (MD & CEO, Maiva Pharma) said: “The inauguration of our Shoolagiri facility represents a major step in Maiva Pharma’s journey to become a globally preferred partner in sterile injectables manufacturing. With advanced manufacturing technologies, expanded capacity, and diversified delivery system capabilities, we are well-positioned to support our customers’ evolving needs and accelerate access to high-quality injectable therapies worldwide.”

The facility has been developed in line with international regulatory standards and reflects Maiva Pharma’s commitment to quality and manufacturing excellence. The expansion significantly enhances the company’s ability to support customers across the product lifecycle—from development through commercial manufacturing—while addressing growing global demand for sterile injectable products. It also advances Maiva’s long-term strategy of expanding its capabilities and strengthening its presence in key global markets.

The post Maiva Pharma inaugurates state-of-the-art sterile injectable manufacturing facility at Shoolagiri, India appeared first on Express Pharma.

Spannende Funktionen und Wettoptionen

Das Angebot zeichnet sich besonders durch seine enorme Tiefe bei Fußballspielen und Live-Wetten aus. Spieler nutzen häufig die Option des Cash-outs, um Gewinne vorzeitig zu sichern oder Verluste zu minimieren. Dabei stehen verschiedene Disziplinen zur Auswahl:

• Klassische Sportwetten auf Top-Ligen
• Spannende Live-Events in Echtzeit
• Langzeitwetten auf Turniersieger

Zusätzlich bietet die Plattform regelmäßige Aktionen an, die das Erlebnis für treue Kunden noch attraktiver gestalten. Es lohnt sich immer, einen Blick auf die aktuellen Bonusangebote zu werfen, um das eigene Budget effizient einzusetzen. Wer Wert auf Seriosität und eine ausgereifte App-Lösung legt, kommt an diesem Anbieter kaum vorbei.

The post Warum bwin eine feste Größe in der Sportwettenwelt bleibt appeared first on Express Pharma.

Vorteile des digitalen Tippens

Die digitale Welt bietet zahlreiche Möglichkeiten, um bequem vom Sofa aus auf große Jackpots zu hoffen. Anstatt physische Annahmestellen aufsuchen zu müssen, können Interessierte rund um die Uhr ihre Zahlen wählen. Zudem profitieren Kunden oft von exklusiven Sonderaktionen, die das Spielerlebnis deutlich abwechslungsreicher gestalten.

Sicherheit und Seriosität spielen bei der Auswahl des Anbieters eine entscheidende Rolle. Nutzer sollten stets auf eine gültige Lizenzierung achten, um ein faires Umfeld für ihre Tipps zu gewährleisten. Verantwortungsbewusstes Spielen sollte dabei immer oberste Priorität haben, damit der Spaß an der Lotterie langfristig erhalten bleibt.

The post Die Welt der Online-Lotterien bei Lottoland entdecken appeared first on Express Pharma.

Une experience de jeu unique

Le site se distingue par sa communauté active et ses nombreux tournois accessibles a tous les niveaux. Que vous soyez un joueur novice ou un habitué des tables virtuelles, la qualité logicielle et le volume de trafic garantissent des parties dynamiques a toute heure de la journee. La fluidite est le maitre mot ici.

En dehors des tables de poker, les paris sportifs occupent une place centrale avec des cotes souvent competitives. Les utilisateurs profitent egalement de contenus exclusifs et d’analyses pointues qui aident a affiner leurs pronostics pour maximiser leurs chances de gains sur le long terme.

The post Decouvrir l’univers du poker et des paris sur Winamax appeared first on Express Pharma.

De voordelen van een betrouwbaar platform

Wat deze aanbieder echt onderscheidt, is de enorme diversiteit aan mogelijkheden voor iedere type gokker. Je vindt hier niet alleen een uitgebreide selectie aan live casino spellen, maar ook talloze opties voor liefhebbers van sportweddenschappen op grote internationale toernooien. Het is belangrijk om altijd verantwoord te spelen en je bewust te zijn van de risico’s die verbonden zijn aan kansspelen.

Daarnaast biedt het platform uitstekende ondersteuning voor klanten die vragen hebben over hun account of specifieke promoties. Kwaliteit en veiligheid staan hierbij voorop, waardoor spelers met een gerust hart hun favoriete spellen kunnen verkennen. Door het ruime aanbod blijf je altijd op de hoogte van de nieuwste trends in de wereld van online wedden en casino entertainment.

The post Alles wat je moet weten over de Unibet ervaring appeared first on Express Pharma.

La qualità dell’offerta ludica

L’integrazione di tecnologie avanzate rende l’interfaccia estremamente intuitiva, facilitando la navigazione anche per i meno esperti. L’esperienza mobile risulta particolarmente curata, permettendo di accedere ai titoli preferiti in qualsiasi momento e da ogni dispositivo. Tra i punti di forza riscontrabili quotidianamente troviamo:

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In conclusione, la proposta di questo operatore rimane un punto di riferimento solido nel panorama nazionale. La costante ricerca di standard elevati assicura un divertimento consapevole e protetto per chi cerca una piattaforma all’altezza delle proprie aspettative. Scegliere un ambiente regolamentato è fondamentale per godersi appieno ogni sessione di gioco.

The post Analisi approfondita dell’esperienza di gioco su leovegas appeared first on Express Pharma.

Hlavní výhody platformy

Pokud se rozhodnete pro registraci, získáte přístup k jedné z největších komunit sázkařů v České republice. Komunitní fórum a možnost sdílení tiketů s ostatními jsou prvky, které dělají hraní mnohem zábavnějším. Kromě bohaté kurzové nabídky můžete využít také různé bonusy a věrnostní programy, které zpříjemňují každodenní sázkařskou rutinu.

Na co si dát pozor

• Vždy si hlídejte nastavené limity vkladů.
• Sázejte zodpovědně a s chladnou hlavou.
• Důkladně studujte analýzy před každým zápasem.

Závěrem lze říci, že Tipsport zůstává silným hráčem, který neustále inovuje své služby. Ať už preferujete fotbal, tenis nebo hokej, vždy naleznete aktuální data potřebná pro úspěšné tipování. Pamatujte, že správný přístup je klíčem k tomu, aby pro vás hazardní hry zůstaly pouze formou zábavy a nikoliv zdrojem stresu.

The post Komplexní pohled na sázení u Tipsportu appeared first on Express Pharma.

Vielfalt und Spannung im Spielangebot

Spieler können aus tausenden Titeln von führenden Softwareanbietern wählen, die für faire Bedingungen und hohe Qualität stehen. Besonders beliebt sind die Live-Dealer-Tische, die ein authentisches Casino-Erlebnis direkt in das eigene Wohnzimmer übertragen. Zudem gibt es einige Vorteile für regelmäßige Besucher:

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• Ein umfangreiches Treueprogramm

Die Sicherheit der Nutzer hat oberste Priorität, weshalb moderne Verschlüsselungstechnologien eingesetzt werden, um alle Daten zu schützen. Wer Hilfe benötigt, findet einen kompetenten Kundensupport, der rund um die Uhr per Live-Chat erreichbar ist. Insgesamt ist der Anbieter eine erstklassige Anlaufstelle für alle, die eine seriöse Umgebung für ihre Freizeitgestaltung suchen.

The post Die Welt der Unterhaltung bei Ivibet entdecken appeared first on Express Pharma.

Ventajas de elegir esta plataforma

Los usuarios suelen elegir este operador debido a la seguridad y la diversidad de opciones de juego. Entre las características más valoradas se encuentran:

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La gestión responsable del juego es fundamental para mantener una experiencia positiva en cualquier plataforma online. Recomendamos siempre revisar los términos y condiciones antes de activar cualquier promoción para asegurarse de cumplir con todos los requisitos necesarios. Disfrutar del entretenimiento de forma consciente es la mejor manera de aprovechar Admiralbet.

The post Explorando la experiencia completa en Admiralbet appeared first on Express Pharma.

Diverse Gaming Portfolio

The library at this casino is curated to provide a wide variety of choices, ranging from traditional table games to cutting-edge video slots. Each title is selected for its high-quality graphics and fair mechanics, ensuring that players have a transparent experience. Quality matters when selecting a platform, and the consistency found here helps keep the lobby feeling fresh and engaging.

Security and responsible play remain at the forefront of the operator’s mission. By providing robust tools for account management and quick support, the team ensures that your focus stays on the enjoyment of the game. Joining the community means accessing a environment where user feedback helps shape future updates and game additions.

The post Exploring the Modern Experience at Betty Casino appeared first on Express Pharma.

Avantajele de a alege acest operator

Platforma se remarca printr-o interfata intuitiva care faciliteaza navigarea rapida intre sectiunile de casino si sport. Utilizatorii apreciaza in special varietatea metodelor de plata si rapiditatea cu care sunt procesate retragerile. Experienta mobila este optimizata impecabil, permitandu-ti sa plasezi pariuri direct de pe telefonul tau oriunde te-ai afla.

De ce prefera pariorii acest site

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In concluzie, alegerea unei platforme cu traditie si reputatie solida poate transforma modul in care interactionezi cu jocurile de noroc online. Indiferent daca preferi fotbalul sau sloturile moderne, acest operator ofera resursele necesare pentru o sesiune relaxanta. Nu uita sa joci responsabil si sa gestionezi cu intelepciune bugetul alocat pentru divertisment.

The post Ghidul complet pentru experienta ta pe Unibet appeared first on Express Pharma.

I vantaggi del portale

La piattaforma si distingue per un’interfaccia intuitiva che permette a ogni giocatore di muoversi agilmente tra le diverse sezioni dedicate alle slot machine e ai giochi di carte classici. La qualità grafica dei titoli è eccellente e garantisce un coinvolgimento costante anche da dispositivi mobili. Ecco alcuni punti di forza che rendono il servizio unico nel suo genere:

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In conclusione, chi cerca una piattaforma affidabile e dinamica troverà qui tutto il necessario per un’esperienza ludica di alto livello. La gestione trasparente del conto di gioco e le promozioni periodiche dimostrano l’attenzione costante verso le esigenze della community. Non resta che provare in prima persona la qualità di questo sito rinomato a livello internazionale.

The post Recensione dettagliata di 888 casino: eccellenza nel gioco online appeared first on Express Pharma.

Bogactwo gier i promocje

Katalog dostępnych tytułów jest stale aktualizowany, co sprawia, że użytkownicy nigdy nie narzekają na nudę podczas rozgrywki. Warto zwrócić uwagę na następujące elementy oferty:

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Wszystkie te aspekty sprawiają, że marka ta utrzymuje wysoką pozycję w branży hazardowej. Regularne turnieje dodatkowo zwiększają emocje, pozwalając na rywalizację z innymi uczestnikami o cenne nagrody. Pamiętaj jednak, aby zawsze grać odpowiedzialnie i traktować rozrywkę jako sposób na miłe spędzenie czasu wolnego.

The post Dlaczego gracze wybierają IceCasino? appeared first on Express Pharma.

Come funziona il sistema di gioco

La meccanica si basa sulla scelta di cinque numeri principali estratti da un set di cinquanta e due numeri aggiuntivi, definiti Euronumeri, scelti tra dodici. Questa struttura unica garantisce dodici diverse categorie di premio, offrendo quindi molteplici probabilità di ottenere una vincita, dalla più piccola fino al tanto ambito jackpot che cresce progressivamente ad ogni concorso senza vincitori.

Per aumentare le probabilità di successo, molti giocatori preferiscono affidarsi a sistemi ridotti o giocare in gruppo con amici. Ricorda sempre che il gioco deve rimanere un divertimento e che non esistono strategie matematiche certe per prevedere i numeri vincenti. Giocare in modo consapevole e responsabile è fondamentale per vivere l’esperienza della lotteria con la giusta serenità.

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Nowoczesne podejście do bukmacherki

Operator ten wyróżnia się na tle konkurencji przede wszystkim innowacyjnymi funkcjami społecznościowymi, które pozwalają użytkownikom na wspólną dyskusję o nadchodzących spotkaniach. Warto podkreślić, że aplikacja mobilna została zaprojektowana z myślą o maksymalnej wygodzie gracza, oferując szybkie wypłaty oraz bogatą ofertę rynków zdarzeń na najpopularniejsze dyscypliny sportowe.

Podsumowując, wybierając tego bukmachera, stawiasz na sprawdzoną markę z pełną licencją Ministerstwa Finansów, co gwarantuje bezpieczeństwo Twoich środków. Niezależnie od tego, czy preferujesz piłkę nożną, tenis czy sporty wirtualne, znajdziesz tutaj coś dla siebie. Pamiętaj jednak, aby zawsze grać odpowiedzialnie i traktować zakłady jedynie jako formę rozrywki.

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Vielfältige Unterhaltung und Bonusangebote

Die Auswahl an Spielen im Verde Casino ist beeindruckend und umfasst tausende Titel von renommierten Softwareentwicklern. Besonders hervorzuheben sind die ständig wechselnden Aktionen, die regelmäßigen Spielern zusätzlichen Mehrwert bieten. Transparenz und Sicherheit stehen dabei stets im Vordergrund, damit Sie sich voll und ganz auf das Spielvergnügen konzentrieren können.

Wer auf der Suche nach einem abwechslungsreichen Erlebnis ist, wird hier sicherlich fündig. Das Portfolio umfasst verschiedene Kategorien wie etwa:

• Klassische Spielautomaten
• Live-Dealer-Tische für ein authentisches Casino-Gefühl
• Progressive Jackpots mit hohen Gewinnchancen

Ein engagierter Kundensupport sorgt zudem dafür, dass bei Fragen oder technischen Anliegen stets zeitnah geholfen wird.

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Spieleauswahl und Funktionen

Das Portfolio bietet eine beeindruckende Mischung aus modernen Spielautomaten und klassischen Tischspielen. Besonders hervorzuheben sind die hochwertigen Grafiken und die flüssigen Animationen, die auch auf mobilen Endgeräten einwandfrei funktionieren. Spieler profitieren zudem von regelmäßigen Aktionen, die das Spielerlebnis abwechslungsreich und spannend gestalten.

Neben der reinen Spielauswahl legt der Anbieter großen Wert auf verantwortungsbewusstes Spielen und transparenten Support. Ein professionelles Team steht bereit, um bei Fragen schnell und kompetent zu helfen. Diese Kombination aus technischer Exzellenz und Service macht die Plattform zu einer festen Größe im heutigen Markt.

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Τα πλεονεκτήματα του παιχνιδιού

Οι παίκτες επιλέγουν τη συγκεκριμένη στοιχηματική εταιρεία κυρίως λόγω της τεράστιας ποικιλίας σε αγορές και αθλητικά γεγονότα. Η ποιότητα των αποδόσεων παραμένει σταθερά υψηλή, προσφέροντας ανταγωνιστικές επιλογές σε καθημερινή βάση. Επιπλέον, το live καζίνο διαθέτει μια εντυπωσιακή συλλογή από παιχνίδια που ικανοποιούν ακόμη και τους πιο απαιτητικούς χρήστες.

Για μια βέλτιστη διαμονή στην ιστοσελίδα, συνιστάται να δίνετε προτεραιότητα στις παρακάτω ενέργειες:

• Επαλήθευση του λογαριασμού σας για άμεσες αναλήψεις.
• Παρακολούθηση των προσφορών που ανανεώνονται τακτικά.
• Χρήση εργαλείων για τον υπεύθυνο στοιχηματισμό.

Κλείνοντας, η πλατφόρμα συνεχίζει να καινοτομεί, εξασφαλίζοντας ένα ασφαλές περιβάλλον όπου η ψυχαγωγία βρίσκεται πάντα στο επίκεντρο κάθε δραστηριότητας.

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Ventajas de elegir una plataforma moderna

Lo que realmente hace destacar a este sitio es la gran variedad de opciones disponibles para los jugadores. Al explorar su catálogo, puedes encontrar desde tragamonedas clásicas hasta mesas de casino en vivo que transmiten una sensación de realismo impresionante. La fluidez de su software es, sin duda, uno de sus puntos más fuertes, permitiendo sesiones de juego estables tanto en computadoras como en dispositivos móviles.

Además de la calidad técnica, el servicio al cliente y las promociones constantes mantienen el interés de la comunidad. Los usuarios suelen valorar positivamente los métodos de retiro rápidos y la transparencia en sus términos. Es fundamental jugar siempre con responsabilidad, estableciendo límites claros que permitan disfrutar de la emoción del azar de manera segura y controlada en todo momento.

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Vielfältige Spielmöglichkeiten

Die Auswahl an Titeln bei diesem Anbieter ist beeindruckend und deckt unterschiedliche Themenbereiche ab. Nutzer finden dort sowohl moderne Video-Slots als auch klassische Tischspiele, die für Begeisterung sorgen. Strategisches Denken ist dabei zwar hilfreich, doch der Spaß am Spiel steht in jeder Situation immer ganz klar im Vordergrund.

Sicherheit und Seriosität spielen bei der Auswahl des passenden Glücksspielanbieters natürlich eine wichtige Rolle. Wunderino setzt auf modernste Verschlüsselungstechnologien, um den Schutz aller persönlichen Kundendaten zu gewährleisten. Dank der übersichtlichen Struktur finden sich sowohl Neulinge als auch erfahrene Spieler schnell zurecht, während der Kundensupport bei aufkommenden Fragen stets freundlich und hilfsbereit zur Seite steht.

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Arihant Innochem (AIPL) has announced the inauguration of the Arihant Innochem Research and Innovation Centre in Navi Mumbai.

The inauguration ceremony was attended by principal partners of the company, including The Lubrizol Corporation, Shin-Etsu Chemical, Asahi Kasei Corporation, MEGGLE Excipients, Chemische Fabrik Budenheim KG, Jungbunzlauer Suisse AG, Pharmatrans Sanaq AG, SEQENS SAS, Sanyo Chemical Industries, YungZip Chemical, Freund Corporation, Pfanstiehl, Inc. and CBC. Representatives travelled from Japan, Switzerland, France and Taiwan to attend the event.

Jinesh Shah, Founder and Managing Director, Arihant Innochem, inaugurated the centre and described it as “a milestone achievement in Arihant’s scientific journey”. He highlighted the company’s principles of growth, innovation and partnerships and said, “Our values, Trust, Quality, and Commitment, have always guided Arihant Innochem. With excipients taking the centre stage, this is the right time to establish Arihant’s own lab where newer ideas can be explored and concepts transformed into solutions.”

The event commenced with an invocation and lamp-lighting ceremony, followed by a welcome address from Radhika Thakkar, Head – Business Development. Chitra Shah, Head – Technical, spoke about the establishment of the laboratory and discussed the role of innovation in the excipient segment.

Dr Sameer Padhye, Manager – Technical Services, presented the capabilities and roadmap of the centre and outlined its role in future research activities.

Attendees were given a tour of the facility, which highlighted its infrastructure and collaborative work environment designed to support scientific research and development activities.

According to the company, the launch of the Research and Innovation Centre marks a new phase in Arihant Innochem’s operations and reflects its focus on innovation and collaboration with principal partners and customers.

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Výhody hraní u tohoto operátora

Hlavním lákadlem této platformy je bezpochyby její intuitivní uživatelské rozhraní, které umožňuje snadnou navigaci mezi sportovním sázením a online casinem. Hráči si zde mohou užít stovky moderních automatů od předních světových vývojářů, jako jsou NetEnt nebo Playtech. Kvalitní zákaznická podpora navíc zajišťuje, že jakýkoliv dotaz je vyřešen během několika minut přes živý chat.

Pro aktivní hráče jsou připraveny pravidelné mise a turnaje, které zpestřují běžné hraní a nabízejí šanci na zajímavé odměny. Doporučujeme vždy sledovat sekci s akcemi, kde se objevují nové bonusy nebo volná zatočení. Sázková kancelář Betano klade velký důraz na zodpovědné hraní, proto nezapomínejte využívat limity a přistupovat k zábavě s rozvahou.

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Prednosti klađenja kod ovog operatera

Ono što ovu kladionicu izdvaja od konkurencije jeste izuzetna ponuda uživo prenosa sportskih događaja. Korisnici mogu pratiti utakmice direktno putem aplikacije, što klađenje čini znatno uzbudljivijim i dinamičnijim procesom. Brze isplate i sigurne transakcije dodatno doprinose poverenju koje igrači imaju prema ovom brendu tokom dugogodišnjeg poslovanja na domaćem tržištu.

Pored sportskog klađenja, platforma nudi i brojne mogućnosti za zabavu u sekciji sa kazino igrama. Ukoliko se odlučite da istražite njihovu ponudu, obratite pažnju na sledeće stavke:

• Bonus dobrodošlice za novoregistrovane članove
• Raznovrsni slotovi i igre za stolom
• Redovne promocije za stalne korisnike

Ovakav sveobuhvatan pristup osigurava da svaki igrač pronađe nešto zanimljivo, bez obzira na svoje prethodno iskustvo u svetu kockanja.

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Miért érdemes ezt a platformot választani?

A felhasználók számára a biztonság és a változatos játékmenet a legfontosabb szempont, amikor egy felület mellett döntenek. Ez a kaszinó hatalmas választékkal szolgál, legyen szó klasszikus nyerőgépekről vagy éppen élő osztós játékokról. A rendszeres promóciók és bónuszok tovább növelik az esélyeket, így mindenki megtalálhatja a számára legmegfelelőbb szórakozási formát.

A kifizetési folyamatok gyorsasága szintén komoly érv a szolgáltató mellett, hiszen a nyereményekhez való hozzáférés ma már elvárás. A platform mögött álló technológiai háttér garantálja a zökkenőmentes játékot, bármilyen eszközről is legyen szó. Az ügyfélszolgálat folyamatosan elérhető, így a kérdésekre vagy esetleges problémákra mindig érkezik gyors és segítőkész válasz.

The post A Vavada kaszinó nyújtotta szórakozás és előnyök appeared first on Express Pharma.

Miért népszerű az oldal a játékosok körében?

A felhasználók számára kiemelten fontos a megbízhatóság és a gyors kifizetés. A felület letisztult dizájnja segíti a navigációt, így a kezdők is könnyen megtalálják a kedvenc nyerőgépeiket vagy asztali játékaikat. Az innovatív megoldásoknak köszönhetően a folyamatok egyszerűbbé váltak, ami növeli a felhasználói élményt a virtuális térben.

Fontos tudnivalók a biztonságos játékról

Minden esetben érdemes figyelni a felelősségteljes szerencsejáték alapelveire. Ne feledjük, hogy a játék elsődleges célja a kikapcsolódás, ezért mindig csak olyan összegekkel játsszunk, amelyek elvesztése nem okoz problémát. A szabályok betartása és a mértéktartás kulcsfontosságú ahhoz, hogy a szórakozás hosszú távon is biztonságos maradhasson mindenki számára.

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Mi teszi vonzóvá a 22bet platformját?

A felhasználói élmény központba helyezése mellett a szolgáltató nagy figyelmet fordít a biztonságra és a gyors tranzakciókra is. A játékosok számára különösen fontosak az alábbi előnyök:

• széleskörű sportfogadási kínálat
• izgalmas élő kaszinó játékok
• könnyen átlátható navigáció

Ezek a tulajdonságok garantálják, hogy kezdők és tapasztalt profik egyaránt megtalálják a nekik tetsző szekciót.

Összességében elmondható, hogy a 22bet stabil választás azoknak, akik egy megbízható és színes választékkal rendelkező portált keresnek. Érdemes tüzetesebben átnézni a bónuszajánlatokat is, hiszen ezek jelentősen megnövelhetik a játékba fektetett tőke értékét. Ne feledd azonban, hogy a szerencsejáték elsősorban szórakozás, ezért mindig tudatosan kezeld a költéseidet.

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Vielfältige Optionen für jeden Spielertyp

Neben den klassischen Wetten bietet das Portal eine beeindruckende Auswahl an Casinospielen an. Ob Sie nun ein Freund von Live-Dealern sind oder lieber an modernen Spielautomaten ihr Glück versuchen, die Auswahl lässt kaum Wünsche offen. Die regelmäßigen Aktionen sorgen zudem dafür, dass sowohl Neukunden als auch treue Spieler immer wieder neue Anreize finden, um ihr Spielerlebnis zu bereichern.

Wichtige Vorteile im Überblick

• Schnelle Auszahlungszeiten bei verifizierten Konten
• Ein breites Spektrum an internationalen Sportligen
• Kompetenter Kundensupport per Live-Chat erreichbar

Zusammenfassend lässt sich sagen, dass das Gesamtpaket überzeugt. Wer Wert auf eine benutzerfreundliche Seite legt und gerne Abwechslung sucht, ist hier genau richtig aufgehoben. Ein verantwortungsbewusster Umgang mit dem eigenen Budget bleibt dabei natürlich immer das Fundament für ein nachhaltiges Vergnügen beim Spielen.

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Sekrety sukcesu owocowych automatów

Mechanika gier w stylu retro stanowi fundament nowoczesnej rozrywki w sieci. Gracze często wracają do tych rozwiązań, ponieważ nostalgia łączy się tutaj z nowoczesnymi technologiami graficznymi. Do najczęstszych zalet wybierania tego typu produkcji należą:

• Szybkie tempo każdej rozgrywki.
• Intuicyjny interfejs użytkownika.
• Wysoka zmienność dająca szansę na wyższe wygrane.

Podsumowując, wybór odpowiedniej platformy jest kluczowy dla komfortu i bezpieczeństwa każdego użytkownika. Warto zawsze sprawdzać licencje oraz opinie innych graczy przed rozpoczęciem zabawy na prawdziwe pieniądze. Odpowiedzialne podejście do hazardu to podstawa, która pozwala czerpać z rozrywki czystą radość bez zbędnego ryzyka.

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Ventajas competitivas del operador

Uno de los aspectos más valorados por la comunidad es la variedad de opciones disponibles para los usuarios. La seguridad y la transparencia son los pilares fundamentales que definen el servicio, garantizando que cada transacción se procese bajo estrictos protocolos de protección. Además, las cuotas suelen ser muy competitivas en comparación con otras casas del sector, lo que atrae tanto a principiantes como a apostadores expertos.

Para maximizar la diversión, es importante aprovechar las funciones de apuestas en vivo que permiten seguir el desarrollo de cada evento minuto a minuto. Contar con herramientas de análisis en tiempo real ayuda a tomar decisiones más acertadas mientras el partido está en juego. Sin duda, es una opción excelente para quienes buscan una experiencia completa y profesional en el mundo de las apuestas digitales.

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Ventajas de jugar en línea

La plataforma ofrece una experiencia de usuario optimizada con una interfaz intuitiva y rápida. Entre sus características principales destacan:

• Variedad en juegos de mesa y tragamonedas
• Pagos rápidos mediante diversas criptomonedas
• Soporte al cliente disponible las 24 horas

En conclusión, quienes eligen esta casa de apuestas valoran la seguridad y la transparencia que brinda la tecnología blockchain. Es fundamental jugar con responsabilidad para garantizar que la diversión nunca se convierta en un problema, aprovechando siempre las herramientas de control que proporciona el sitio para gestionar los tiempos y presupuestos personales de cada usuario.

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Γιατί να επιλέξετε την πλατφόρμα

Η ποιότητα των υπηρεσιών είναι το βασικό κριτήριο για την επιλογή ενός ιστότοπου τυχερών παιχνιδιών. Οι χρήστες αναζητούν ταχύτητα στις πληρωμές και πληθώρα αγορών για να τοποθετήσουν τα στοιχήματά τους. Η συγκεκριμένη ιστοσελίδα προσφέρει:

• Μεγάλη γκάμα αθλητικών γεγονότων παγκοσμίως.
• Ζωντανή μετάδοση αγώνων σε υψηλή ανάλυση.
• Εύχρηστο περιβάλλον για κινητές συσκευές.

Κλείνοντας, η ασφάλεια των δεδομένων και ο υπεύθυνος στοιχηματισμός παραμένουν οι πυλώνες πάνω στους οποίους οικοδομείται μια υγιής σχέση με τον παίκτη. Η διαρκής υποστήριξη πελατών διασφαλίζει ότι κάθε απορία σας θα επιλυθεί άμεσα, επιτρέποντάς σας να εστιάσετε αποκλειστικά στη διασκέδασή σας στο παιχνίδι.

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Dlaczego warto wybierać sprawdzonych operatorów

Wybierając bukmachera, gracze zwracają uwagę przede wszystkim na bezpieczeństwo oraz różnorodność dostępnych rynków zdarzeń. STS wyróżnia się na tle konkurencji wieloma funkcjonalnościami, takimi jak transmisje na żywo czy możliwość szybkiego wypłacania wygranych środków. Odpowiedzialna gra stanowi fundament, o którym musi pamiętać każdy użytkownik, niezależnie od poziomu doświadczenia w obstawianiu.

Podsumowując, regularne śledzenie zmian w propozycjach zakładów pozwala na lepsze zarządzanie kapitałem oraz wyłapywanie wartościowych kursów. Warto pamiętać o regularnym sprawdzaniu dostępnych promocji, które mogą uatrakcyjnić codzienną grę. Dobre przygotowanie merytoryczne to klucz do czerpania przyjemności z obstawiania ulubionych dyscyplin sportowych w sposób przemyślany i rozważny.

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The FDA’s decision follows data from a Phase Ib study on salanersen, presented at the 2026 Muscular Dystrophy Association Clinical and Scientific Conference and the fifth International Scientific Congress on SMA Europe 2026.

The study included children with SMA who had previously responded suboptimally to gene therapy.

Once-yearly administration of salanersen led to marked improvements in motor function and a slowdown in neurodegeneration, measured by reduced neurofilament levels. The treatment was generally well-tolerated.

Biogen rare neurology development unit head Stephanie Fradette said: “This designation reflects the FDA’s determination that salanersen has the potential to demonstrate substantial improvement over available therapies.