Billions More in M&A, Another Bidding War and More FDA Drama

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BioSpace

182 episodes

4 days ago

Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.

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Billions More in M&A, Another Bidding War and More FDA Drama

BioSpace

21 minutes 19 seconds

4 days ago

Billions More in M&A, Another Bidding War and More FDA Drama

Acquisitions have ticked up this month as all eyes were on Pfizer and Novo’s fight over Metsera. The past week saw that deal finalized with Pfizer as the winner plus a handful of other M&A stories, including Merck’s $9.2 billion buyout of Cidara Therapeutics and Johnson & Johnson’s $3 billion bet on Halda Therapeutics. Additionally, a separate bidding war has broken out between Lundbeck and Alkermes for sleep biotech Avadel Pharmaceuticals.

Outside of M&A, the FDA dominated headlines again this week. The agency effectively closed the loop on one of the messiest stories of the year—Sarepta’s gene therapy Elevidys—when it formally added a black box warning for serious liver toxicities and risk of death and removed the nonambulatory indication from the label. The agency will also require that the company complete a postmarketing observational study of around 200 patients.

This happened just as Richard Pazdur accepted the role of director of the Center for Drug Evaluation and Research (CDER) that was recently vacated by George Tidmarsh amidst conflict with Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad. By all accounts, Pazdur, a 26-year FDA veteran, is a highly respected and thoughtful regulator, and sources told BioSpace that if Prasad tries to supersede Pazdur’s authority, “there will be hell to pay and resignations to be handed in.”

In other FDA drama, FDA Commissioner Marty Makary is apparently butting heads with Health Secretary Robert F. Kennedy Jr. Meanwhile, the agency revealed details of its plausible mechanisms pathway teased by Makary earlier in his tenure.

Finally, in Biopharm Executive this week, check out our deep dives into GLP-1 pricing. Coming off Trump’s deal with both Eli Lilly and Novo Nordisk to offer their GLP-1s at a lower cost through the president’s new direct-to-consumer platform, Novo CEO Maziar Mike Doustdar announced a sale on its company’s products. Bargain bin pricing like this so early in a drug’s market life is unprecedented. It’s changing the investment calculations for the next-generation of obesity treatments.