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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“We are grateful to the NIA for their rigorous scientific review and funding support to advance ALZ-8801 for Alzheimer’s patients in need of an effective treatment,” said Martin Tolar, founder, president and chief executive officer of Alzheon.
The agency indicated that they had completed the review cycle for the application but the application was not ready for approval in its current form.
The company indicates the agency requested data from the MANTA and MANTA-Ray trials before completing its review of filgotinib. Here’s more about it.
This morning, Mylan announced the launch of its new generic offering, dimethyl fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis.
The legal ruling, subject to appeal, protects the Swiss pharma giant’s revenue stream from the blockbuster drug Gilenya for a little bit longer.
Shares of Poseida Therapeutics plunged more than 20% in premarket trading this morning after the company announced the U.S. Food and Drug Administration halted a cancer drug trial due to safety concerns.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 19, 2020.
In the midst of an international pandemic, three high-profile public health officials are leaving government service.
The U.S. Food and Drug Administration approved Genentech’s Enspryng (satralizumab-mwge) as a subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 17, 2020.