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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Specifically, the new approval was for adults with dMMR recurrent or advanced solid tumors who have progressed on or after previous treatment and who have no satisfactory alternatives.
The latest biopharma insider trading scandal stems from Pfizer’s acquisition of Medivation in 2016.
As COVID-19 surges to earlier pandemic levels in the U.S., federal health officials are expected to authorize a third booster shot eight months after receiving the second of the Moderna and Pfizer-BioNTech vaccines, and probably the Johnson & Johnson vaccine as well.
In the past few weeks, China reminded the world that it is, first and foremost, a Communist nation. The recent crackdowns on the high-tech and education industries make some wonder what other changes will be next.
In a patent infringement lawsuit filed against Eli Lilly, Teva Pharmaceuticals won three and lost six patents. The patent lawsuit was over Teva’s Ajovy (fremanezumab-vfrm) to prevent migraines.
As the COVID-19 pandemic continues with surges in the U.S. in unvaccinated people, biopharma companies are still working on new vaccines and therapies against the disease.
Patient enrollment in the Phase I study will resume, the company announced this morning.
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications.
The U.S. FDA had a very packed calendar for this week, but almost everything on it was under a Priority Review pathway.
The amended EUA is aimed at patients who have undergone solid organ transplants or those diagnosed with conditions that have an “equivalent level of immunocompromised.”