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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Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the “very rare” risk of non-arteritic anterior ischemic optic neuropathy.
Vaccine skepticism is at an all-time high in the U.S., and HHS Secretary Robert F. Kennedy Jr. is making some drastic moves in the name of reversing that trend. But misinformation and inconsistencies within the country’s healthcare agencies highlight problems with his approach.
The lawsuit alleges that HHS leadership knew the records they used to guide their layoff decisions were inaccurate and contained errors.
In comments posted in response to the Trump administration’s pharma tariff investigation, companies and industry groups offered solutions to ease the impacts if the plan must go ahead.
The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, power has shifted from federal agencies to the courts, with potential implications for everything from the FDA shortage list to CMS drug price negotiations.
According to the nonprofit news outlet NOTUS, at least seven studies cited in the Make America Healthy Again report released last week are nonexistent. The White House shrugged off questions about the errors.
In a letter to the Department of Commerce, Novo Nordisk argued that unsanctioned compounded semaglutide, mostly from China, constitutes a national security threat to the U.S.
Leerink Partners previews the drugs likely to be subject to the Inflation Reduction Act’s next price negotiations as the program expands to Medicare Part B and smaller biotechs.
A February executive order on pharmaceutical price transparency does nothing to change the incentives that keep costs opaque. But drug companies and other stakeholders would reap the benefits of such disclosures.
In a video posted to social media on Tuesday, HHS Secretary Robert F. Kennedy, Jr. claimed that there is a lack of clinical data to support the repeat COVID-19 booster strategy in children.