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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Trade tensions between Washington, D.C. and Beijing continue, but have not yet impacted the pharmaceutical products traded between the two countries. However, if the punitive tariffs continue and pharma is impacted, a third global player could step in to fill the void in both countries.
Transparency in clinical trials has been a concern and the new study highlights the continued issue.
In light of the Center for Disease Control and Prevention’s guidelines for safe cold chain vaccine storage, pharmacies have an increasing need for electronic temperature monitoring and alarming.
The lawsuit was joined by Merck, Eli Lilly and Amgen. The companies claim the Department of Health and Human Services does not have the legal authority to force the companies to comply with the new rule.
KB105 is a new gene therapy candidate engineered with a Transglutaminase-1 (TGM1) gene construct to treat TGM1 deficient autosomal recessive congenital ichthyosis
June is turning out to be a busy month for approvals for the U.S. Food and Drug Administration. The agency has a slate of PDUFA dates this week, including two for Merck alone. Here’s a look.
The stool sample used in the experimental procedure was not properly tested, the FDA said.
Amarantus Bioscience Holdings, Inc. announced that subsidiary MANF Therapeutics was issued U.S. Patent No. 10,195,251 entitled ‘Methods of Treatment for Retinal Diseases Using MANF and CDNF’ that covers the use of mesencephalic astrocyte-derived neurotrophic factor or cerebral dopamine neurotrophic factor as a treatment for various ophthalmic disorders, including inherited retinal disorders, age-related macular degeneration and glaucoma.
The pilot program aims to develop an electronic system to identify and trace certain prescription drugs as they are distributed within the United States.
Efforts undertaken by state and local leaders across the five states that make up Pharm Country have led to a boost in business, which is good news for applicants seeking a new position.