Policy
Jim O’Neill was deputy secretary at the Department of Health and Human Services and also acting director of the CDC after the abrupt ouster of Susan Monarez in August 2025.
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.
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AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per month.
Merck is having a very busy week. Here’s today’s news.
Servier was found guilty of manslaughter and deceptive marketing practice for its Mediator drug for weight loss. The Paris-based company was fined $3.12 million.
The report listed four scenarios in order of likelihood, with the top being from bats through another animal.
The FDA-approved ide-cel, which will be marketed under the brand name Abecma is going to be the second therapy for myeloma. Here’s everything you need to know.
The Orphan Drug Act passed in 1983 and granted tax credits, subsidies and fee waivers for rare disease drug development in areas of unmet need. It also guaranteed seven years of market exclusivity following approval, longer than the five years typical for most new chemical entities.
As this week’s FDA Action Alert emphasizes, not everything goes as planned with the U.S. FDA. With three PDUFA dates, two of them ran into issues. Read on to find out more.
There appears to be some evidence that the agency is cracking down in general, although there’s debate among analysts about what exactly is going on.
What has been learned about SARS-CoV-2, the virus that causes COVID-19, in only about 15 months, is truly a historical scientific achievement. And new information continues to come in.
Three days after U.S. Food and Drug Administration staff raised safety concerns over Pfizer’s and Eli Lilly’s NGF osteoarthritis drug tanezumab, an advisory panel has also posted its own objections.