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Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Heightened diligence standards and longer decision timelines for early-stage startups slowed venture activity last year, J.P. Morgan found in a report published ahead of the bank’s annual healthcare conference in San Francisco.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
THE LATEST
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
The number of employees laid off increased year over year during the first quarter. BioSpace recaps the five largest rounds of layoffs, which included BMS and Novartis cuts.
It’s another wild twist in the story of Galapagos, a company that has been around for more than 25 years but has yet to get a therapy approved.
Meanwhile, Bayer CEO Bill Anderson said Donald Trump’s Most Favored Nations policy could present an opportunity for European countries to make sure they are also funding their “fair share” of biopharma innovation.
The commitment is part of Roche’s recently announced $50 billion investment in the U.S., but a company spokesperson said that could change if certain yet-unspecified policies are implemented that could “harm our industry’s ability to operate and innovate in America.”
The third cycle of the drug price negotiations will involve drugs under Medicare Part B. New prices are set to take effect in 2028.
The Most Favored Nation directive would allow drugmakers to directly sell their products to patients at a lower cost, cutting out what President Donald Trump called “the middlemen.”
Azafaros will use the Series B haul to push lead asset nizubaglustat into late-stage studies for Niemann-Pick disease Type C and GM1/GM2 gangliosidoses later this year.
While industry groups decried the Trump administration’s new drug pricing order, analysts say it lacked details and the teeth to make a major impact without an act of Congress.
Lexeo wants to more quickly move investigational gene therapy LX2006 into a registrational study and hopes for a potential efficacy readout in 2027.