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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
The CDC supported the FDA’s approval of mixing and matching vaccines, where eligible populations can take a booster shot from another brand different from their initial series.
The upcoming changes will be less disruptive but will have far-reaching consequences throughout the pharmaceutical supply chain.
An experimental AstraZeneca cancer drug trial has been placed on hold due to safety concerns. This news comes two years after Amgen was also forced to pause a study of a drug within the same class.
A subtype of the Delta variant might be rising, although it’s not yet clear if it’s more transmissible or lethal than the original Delta variant. Read on for that and more COVID-19 news.
The experimental drug, NTLA-2001, is being developed for the treatment of transthyretin (ATTR) amyloidosis.
More than $170 million was paid out for drugs that manufacturers voluntarily withdrew from the market after subsequent trials showed no benefit in overall survival.
With expectations that the U.S. FDA will announce a decision about booster shots for the Moderna and Johnson & Johnson vaccines this week, there is plenty of COVID-19-related news. Here’s a look.
Flu season is here and overall viral activity is up 23% across the United States, even as respiratory syncytial virus and COVID-19 infections continue to sweep across parts of the nation.
The concern relates to the risk of two rare heart inflammation conditions, myocarditis and pericarditis, that have been linked to the Pfizer and Moderna mRNA vaccines.
The U.S. Food and Drug Administration has a few PDUFA dates on its calendar for this week. Here’s a look.