India

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

Following past challenges on the US market, the Indian pharma player Wockhardt will be shuttering its presence in the country due to commercial reasons.

Cipla will look to give its US operations a boost later this year by launching only the second Abraxane ANDA product.

India and the US are the major manufacturers of finished dosages for the US market in terms of volume (China accounts for 9% of injectables), though the US relies heavily on India for solid oral dosage forms and specific generics, including lenalidomide and albuterol. Scrip talks to experts on some of the key implications of geographic concentration of production for the US market amid the specter of tariffs.

The company did not disclose which particular drugs it secured through the deal that further boosted its portfolio that already includes more than 100 assets.

Lupin’s UK subsidiary acquired the British firm for an undisclosed sum of money, adding further assets into the company’s armamentarium.

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Bharat Biotech is the latest entrant in India’s cell and gene therapy space, joining majors like Intas Pharma, Sun Pharma, Cipla and Dr. Reddy’s. An indigenously developed CAR-T cell therapy launched last year, what is driving growing interest and success in cell and gene therapies?

Trump announced a 26% reciprocal tariff on India but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms and the US consumer are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?