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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 20, 2020.
Wrapping up the month of July, there are three PDUFA dates on the U.S. Food and Drug Administration (FDA) calendar.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 17, 2020.
A dramatic increase in COVID-19 testing and tracing is needed in order to put the United States on a surer path through the pandemic. But that diagnostics increase comes with a significant price tag of about $75 billion from the federal government, the Rockefeller Foundation said in its latest report.
Shares of Mallinckrodt climbed after the company announced the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration voted to recommend approval for its investigational agent terlipressin to treat adults with hepatorenal syndrome type 1.
“We are pleased the committee recognized the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options,” said Axel Hoos, senior vice president and heat of Oncology R&D for GSK.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 15, 2020.
An unnamed U.S. official told the news agency that vaccine manufacturing under development in conjunction with the federal government’s Operation Warp Speed program is likely to begin within the next four to six weeks.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 13, 2020.
The designation will provide for an expedited pathway for regulatory review of the preventative medication, which could come later this year.