Policy
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
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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.
Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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The U.S. Food and Drug Administration issued a warning letter to the company for misbranding its opioid addiction medication Vivitrol in promotional materials.
H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (cited as the Lower Drug Costs Now Act of 2019), awaits a vote by the House in December.
Research shows modulation of the Hedgehog and androgen signaling pathways to discontinue the vicious circle leading to inflammation in the central nervous system and chronic demyelination
The company calls the system the first and only “ingestible event marker to transmit digital messages” from inside the body to a receiver without need for direct skin contact.
Shares of France-based Ipsen are down more than 2% on the Euronext Paris exchange after the U.S. Food and Drug Administration placed a partial clinical hold on its investigational treatment for fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO).
Prescription drug prices dropped 1% last year, the first time such a drop has occurred in the United States in 45 years. The drop was driven primarily by a greater reliance on generic drugs and much slower increases in branded drugs, according to a government study.
Earlier this week, an HIV-prevention advocacy group, PrEP4All Collaboration, filed a petition with the U.S. Patent and Trademark Office (PTO) alleging that Gilead Sciences intentionally delayed the development of a safer HIV drug.
Two weeks after the pharmaceutical industry predicted dire consequences for innovation if the prescription price reduction plan proposed by House Speaker Nancy Pelosi passes, the White House is now echoing those concerns but suggesting even worse outcomes than industry analysts predict.
The U.S. Food and Drug Administration approved Genentech’s Tecentriq plus chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer.
New certification demonstrates commitment to the highest standards of data protection across the company’s operations, systems, and products