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 FY20 Defense Appropriations Act provides funding to the Department of Defense Peer Reviewed Medical Research Program to support medical research projects of clear scientific merit and direct relevance to military health.
In a filing this week, the government said that tens of thousands of patients received “unreliable blood tests,” which deprived them of money and placed their health at risk.
In a painful blow to the San Francisco-based company, the committees voted unanimously, 27 to 0, not to recommend approval.
Candidates pointed out ways they would use the power of the federal government to lower the cost of medications in the United States.
The Institute of Cancer Research, London, strongly welcomes the recommendation by the Scottish Medicines Consortium to make the prostate cancer drug abiraterone, when given alongside hormone therapy, available to men with advanced prostate cancer as first-line treatment on the NHS in Scotland.
Auris Medical Holding Ltd. announced that the European Patent Office has issued a notice of “Intention to Grant” for its patent application entitled “Treatment of Tinnitus Through Modulation of Chloride Co-Transporter NKCC1 in the Auditory System”.
Joe Rymsza, vice president of Pharmacovigilance and Regulatory Technology Solutions for IQVIA, took time out to discuss trends in PV and regulation in the biopharma industry in the coming year.
As is often the case at the beginning and end of the year, a number of companies announced layoffs. Other news is related to lawsuits and an overall positive story about cancer death rates. Here’s a look.
With a new year underway, the U.S. Food and Drug Administration is doing some house-cleaning of sorts.
The State of California is considering a measure to sell its own brand of generic drugs in an effort to get in on those cost-savings. California’s Gov. Gavin Newsom is expected to reveal the scheme today in his new state budget.