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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With the Omicron surge waning, at least in the U.S., there is speculation that the COVID-19 pandemic may be in its end stages. Some experts, however, warn that this could be premature.
After a filibuster was broken Monday, the Senate confirmed Califf’s nomination in a 50-46 bipartisan vote.
After announcing that the FDA was investigating a possible death associated with its lymphoma drug Ukoniq (umbralisib), things are seemingly looking up for TG Therapeutics.
Robert Califf’s nomination to resume his role as FDA Commissioner continues to advance in the Senate, despite some opposition from a key Democrat, Sen. Joe Manchin.
Since 2016 the state has offered more than $70 million in tax credits to 114 different entities and has generated about $140 million in investments into the state’s life sciences ecosystem.
CMS says it would only cover the cost of Biogen’s Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
Stoughton, Mass.-based Collegium Pharmaceutical is expanding its pain-treating portfolio with a $604 million buyout of Raleigh’s BioDelivery Sciences International (BDSI).
Although the Omicron surge appears to be waning in the U.S., the World Health Organization keeps an eye on four Omicron subvariants.
Pfizer indicated it will wait for the full data on a three-dose series of the vaccine for that population, believing it “may provide a higher level of protection in this age group.
Shares of Cassava Sciences are up more than 5% in premarket trading after the FDA denied a Citizen Petition filed last year to suspend the company’s Alzheimer’s clinical trials.