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 regulator Monday approved the companies’ supplemental Biologics License Applications for their respective mRNA shots formulated to more closely target currently circulating variants.
After its prostate cancer therapy was not included in Medicare’s initial drug price negotiation list, Astellas dismissed its Inflation Reduction Act lawsuit this week, while Illumina got new leadership.
After a three-month delay, GSK expects an FDA verdict for its myelofibrosis candidate, while Alnylam gears up for an advisory committee meeting discussing patisiran in cardiomyopathy of ATTR amyloidosis.
Blue Cross and Blue Shield of Louisiana has filed a case against Bristol Myers Squibb alleging the company conducted patent fraud to extend protections for its multiple myeloma drug Pomalyst.
The company has withdrawn a suit against the Department of Health and Human Services after its prostate cancer therapy was not included in Medicare’s initial drug price negotiation list.
Citing the need to improve its Risk Evaluation and Mitigation Strategy, the regulator has declined AstraZeneca’s bid to get its C5 complement inhibitor approved in neuromyelitis optica spectrum disorder.
Monitoring rebates from drugmakers will be critical as provisions of the Inflation Reduction Act are implemented, including drug price negotiations, the Government Accountability Office contends.
With several of the first 10 selected drugs facing patent expirations and generic competition, the drug price negotiations dictated by the IRA may not greatly affect revenues. But that could change quickly.
The Swiss pharmaceutical company filed a suit Friday joining a growing group of legal complaints by Big Pharma seeking to block the Inflation Reduction Act’s Drug Price Negotiation Program.
$27.8B Amgen-Horizon deal gets FTC clearance with restrictions; the White House names first 10 drugs subject to Medicare price negotiations; Sage Therapeutics axes 40% of staff.