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.

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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.

Contract research organizations in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.

Alkem and Torrent said the tested batches were not manufactured by them, as a recent CDSCO report pinned their drugs as “not of standard quality”. Meanwhile, other firms informed the agency themselves about counterfeit drugs on the market.

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.

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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.

The US FDA has issued a Form 483 to Granules India, with six observations, spanning document and vent mismanagement to bird droppings and rust.