India

A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.

Indian CMOs, CDMOs and CRDMOs are expanding capacity and making leadership moves ahead of the BIOSECURE Act, anticipating demand from big pharma and budding biotechs. Scrip brings details on leading Indian firms which could be potential go-to suppliers for US companies affected by the proposed Act

Syngene’s CEO talks to Scrip about how the firm is deepening capabilities in areas like ADCs, PROTACs and why the US Inflation Reduction Act may not necessarily shrink outsourced small molecule work. The executive also shares his view on the China ‘rebalancing’ trend amid geopolitical tensions and the US BIOSECURE Act.

Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.

A high-profile panel that included a senior executive from F-Prime Capital, Novo Nordisk's India chief and a leading endocrinologist discussed, at a recent event, some of the big opportunities, challenges and transformational trends underway as obesity drugs take the world by storm.

GSK’s India chief talks to Scrip about new category creation in adult immunization with Shingrix seeing strong uptake, Nucala and Trelegy’s trajectory and oncology assets set for debut as the company steps into its 100th year of operation in the country. GSK expects to continue to transform its operating model as things evolve, he indicates in the concluding part of this interview.

GlaxoSmithKline Pharmaceuticals’ MD tells Scrip how the company has been able to reinvent itself, contemporize brands and get supply chain innovation right as the UK-headquartered firm marks 100 years of operations in India. GSK’s equivalent of the 'Amazon model' for vaccine ordering and the new temples of industry are some of the other facets the executive discussed in the first instalment of this two-part interview. 

A redistribution of pharma outsourcing activities, both ex-China and also a wider shift in CDMO work from North America down the line may be in store. A senior McKinsey executive discusses with Scrip these trends in the CDMO sector amid geopolitical tensions, the spurt in customer queries at Indian firms and also facets of the deals scenario.

Human milk could have a role in preventing Alzheimer’s disease and other ailments linked to the gut microbiome, says former Pfizer VP and Hilleman CEO Davinder Gill. He also talks about a halal meningitis vaccine, and tailwinds for an oral cholera vaccine now launched by Bharat Biotech in this fascinating interview

Kamil Hamied, son of Cipla’s outgoing vice-chair M K Hamied, is set to re-join the company as non-executive director, following his "entrepreneurial journey." Does it signal a shift in the promoter group’s immediate considerations amid past stake sale speculation or mark routine top-level executive changes?

"Illegal" copies of Pfizer’s Lorbriqua and Eli Lilly’s Verzenio have been seen making their way to India allegedly via manufacturers in Bangladesh. The US multinationals are engaged in a legal battle in India to tackle the ‘infringement’ amid wider concerns around inadequate regulatory oversight.

A licensing deal for Leqvio (inclisiran) is all in a day’s work for Mankind which also recently acquired Bharat Serums and Vaccines at a valuation investors were initially not entirely pleased with. As the youngest company in the top five of the domestic pharma market sets a 5X revenue target, what could help it get there and what’s to watch out for?

Does Zydus’ 50% stake acquisition in Sterling Biotech reflect a broader move of formulations companies to secure API supplies or acceleration of API segment restructuring begun by a couple of private equity (PE) funds?

Indegene’s CTO talks to Scrip about the state of GenAI implementations in pharma amid hype and limited clarity on ROI, the need to address foundational issues early on, promising pilots, the firm’s alliance with Microsoft and Google’s generalist LLM for therapeutics.

Serum Institute is working on an mpox vaccine while other Indian firms are weighing options after the WHO sounded an alert and a new case was reported in neighboring Pakistan. Scrip looks at factors that could favor development and/or manufacture of an mpox vaccine at Indian majors.

Momentum in Europe may see the region’s contribution to Glenmark’s revenues become almost as big as the US business, currently dented by multiple challenges. The firm also outlines how things are poised in India for its biosimilar to Novo Nordisk’s Victoza.

Zydus has begun Phase I trials for an anti-properdin drug in India while its sitagliptin franchise in US, distinct from Merck’s Januvia and Janumet, looks promising. Meanwhile MD Sharvil Patel says a biosimilars entry in developed markets is possible if certain conditions are met.

Biocon maintains it doesn’t expect the US to remain an eight to 10 player market for adalimumab biosimilars for long and also outlines expectations for its GLP-1 portfolio, led by liraglutide, seen as a major growth driver in the coming years.

Lupin’s CEO highlights market access strategy as a key tool to ensure biosimilars success in the US while being relieved the company didn’t launch a Humira biosimilar. She also mentions Amazon and Mark Cuban have not upset market dynamics for generics in the US and a Lucentis biosimilar is closer to a global launch post Phase III trial success

Otsuka Pharma’s acquisition of Jnana seems like a win for its pipeline, but the Japanese major faced a setback in a Delaware District Court where the judge’s opinion put challenger Lupin closer to a generic to its Jynarque (tolvaptan)