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.
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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 filing accused Mayne Pharma, which also has operations in the U.S., of breaching disclosure obligations with regard to anti-competitive conduct.
Seventeen years after buying global rights, AstraZeneca is finally announcing a win for the lupus community with an FDA approval for Saphnelo.
Rep. Michael McCaul issued a third installment today into the origins of the COVID-19 virus and blames the pandemic on a leak from the Wuhan Institute of Virology in China.
The U.S. FDA is starting off August with a mix of PDUFA dates for acne products, seizure medications and a new manufacturing process for a non-opioid pain killer. Here’s a look.
The U.S. Centers for Disease Control and Prevention issued a warning that the Delta variant is as infectious as chickenpox and can cause a much more severe COVID-19 infection.
The U.S. Securities and Exchange Commission has halted registrations of U.S. initial public offerings (IPOs) by Chinese companies.
The panels discussed key issues such as expanded access programs (EAPs), clinical trial diversity, conditional approval pathways, and patient experience data.
Kaiser Permanente has reportedly filed a lawsuit against drug maker Merck for allegedly allowing a “pay-for-delay” scheme that cost the former millions of dollars.
As COVID-19 infections continue to increase in the U.S., the FDA has expanded the EUA for Eli Lilly’s monoclonal antibody to include treatment with or without remdesivir.
AstraZeneca said in an earnings announcement on Thursday it will seek authorization for its COVID-19 vaccine in the U.S. sometime in the second half of this year.