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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Former commissioner of the U.S. Food and Drug Administration, Scott Gottlieb, although not running for office (that we are aware of), recently published commentary urging the United States to avoid making it more difficult for poor people to gain access to cutting-edge medications.
The decision, which is likely to be appealed, will allow Dana-Farber to license the technology.
The FDA extended the indication for Gattex to pediatric patients one year of age and older with short bowel syndrome.
NAYZILAM was approved to treat frequent seizure cluster episodes in epilepsy patients.
Project Facilitate is a pilot project to create a single point of contact for the FDA’s oncology expanded access requests.
Pfizer’s Fragmin was approved to reduce the recurrence of VTE in patients one month of age or older.
More than 12,000 buyers visit 2019 fair, up 8% on last year
Probiodrug AG announced today its first quarter business update for the period ending March 31, 2019.
Pharming Group N.V. presents its (unaudited) interim financial report for the first quarter ended 31 March 2019.
The plaintiffs allege that Gilead and other companies used anticompetitive tactics to keep prices artificially high for their respective HIV treatments.