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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Following a court’s ruling last week over a partial clinical hold placed on the company in 2018 by the U.S. Food and Drug Administration, Vanda Pharmaceuticals said it is undertaking a “comprehensive review” of the decision and will then determine the next appropriate steps.
The active component of the drug, sodium valproate, has been on the market for epilepsy and bipolar disorder since 1967.
MedAlliance has announced the award of its first CE Mark approval: for SELUTION SLR™, a novel Sirolimus Drug Eluting Balloon, for the treatment of peripheral arterial disease.
GBA Group Pharma has informed its industry partners and clients on risks to their clinical trial plans caused by Brexit and is highlighting the significant business difficulties for healthcare companies running clinical trials through UK-based organisations.
Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.
The spreading of the coronavirus that began in Wuhan, China has researchers and health officials worldwide studying the emerging virus and preparing to treat it and develop vaccines. With such an enormous global focus, it seems that new information about the virus and the infection is being published each day.
The focus of the research will be to learn more about ApoE4 and how and why it affects Alzheimer’s disease.
The study notes that about half of recent drug approvals were built on a single pivotal clinical trial. Typically, two pivotal, Phase III trials were the norm.
The U.S. Department of Justice has leveled more charges against members of the U.S. science community who have alleged ties to China.
In the complaint, the FTC alleged an “elaborate anticompetitive scheme to preserve a monopoly” on Daraprim.