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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The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL), basically a rejection, to Netherlands-based Pharming Group for its supplemental Biologics License Application (sBLA) for Ruconest.
Clovis Oncology will pay more than $20 million in penalties to settle charges that Chief Executive Officer Patrick Mahaffy and its former Chief Financial Officer Erle Mast misleading investors about the company’s lung cancer treatment leading up to a public offering of stock.
Illinois-based AbbVie is under fire from California’s Insurance Commissioner over allegations of a kickback scheme to support sales of blockbuster rheumatoid arthritis treatment Humira in the state.
BeiGene to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies
SenzaGen has been notified by the European Center for the Validation of Alternative Methods (ECVAM) authority that due to time constrains their scientific committee (ESAC) will not be able to evaluate tests in the category ”Test Guidelines on Health Effects”, to which GARDskin belongs, this year.
NCPA CEO’s STATEMENT ON SENATE PASSAGE OF S.2554
A second former GlaxoSmithKline scientist has pled guilty to stealing trade secrets as part of a scheme to benefit a startup China-based pharmaceutical company he helped establish.
In a 99 to 1 vote, the Senate passed the bill that looks to cut down on the flow of illegal narcotics entering the United States through the mail, as well as taking aim at the abuse of prescription opioid medication – a problem that has grown to an epidemic in the United States.
As Novartis looks to regain its reputation following a series of ethical blunders, the company unveiled a new ethics scoring system that will be tied to employee bonuses.
Hemophilia patients could have an easier time taking their medication if the U.S. Food and Drug Administration (FDA) gives the green light for the newest indication of Genentech’s Hemlibra for patients who do not have Factor VIII inhibitors.