Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
The FDA granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) for IPD and pneumococcal pneumonia Breakthrough Therapy Designation.
Protagonist disclosed the FDA issued a letter of intent to rescind the status for rusfertide based on concerns first raised in a clinical hold placed on the drug.
The FDA has sprung into action, cracking down on the illegal sales of Adderall, as well as on CBD companies making claims their products are effective treatments or cures for COVID-19.
As Martin Shkreli, Elizabeth Holmes and Sunny Balwani, and the Purdue bankruptcy deal play out, there is even more drama beyond the stories–a failure to pay legal fees.
Myovant said that the FDA provided notice it had found deficiencies that will preclude any potential discussion of labeling or post-marketing requirements at this time.
As Aeglea presents the data this week at the Society for Inherited Metabolic Disorders (SIMD), its stock has responded to both announcements with a strong leap.
Following the decision to limit the coverage of Biogen’s controversial Alzheimer’s drug Aduhelm, the Alzheimer’s community is now waiting for other companies to deliver new therapies.
The FDA is looking at revising the current vaccine strategy and emphasizing that individuals need to consider their own risk tolerance. For that and more, continue reading.
The new bills result from a three-year investigation that honed in on anti-competitive efforts that have prevented generic drugs and biosimilars from entering the market.
Janssen Pharmaceutical, under parent organization Johnson & Johnson, secured an arbitrary win this week that results in royalty decisions stemming from licensing and marketing of daratumumab.