Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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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The FDA, as part of efforts to update clinical trial eligibility criteria, published four draft guidance documents on cancer clinical trial criteria and one final draft on adolescents in adult oncology trials.
The FDA issues Warning Letters to biopharma, medical device and food companies when they find that a manufacturer has significantly violated FDA regulations. As of March 4, the agency issued 45 Warning Letters this year.
National Cancer Institute Director Norman “Ned” Sharpless will take over the role as acting commissioner of the FDA while the White House seeks a permanent replacement for the outgoing Scott Gottlieb.
The U.S. Food and Drug Administration has been busy approving new treatments for various diseases. Two days into the new week and the regulatory agency has green lit two therapeutics, while other companies are planning to file for potential approval.
The president’s proposed spending plan cuts $4.5 to $5.5 billion from the current budget of the National Institutes of Health, about an 11 percent decrease from 2019.
Shares of CURE Pharmaceutical jumped more than 15 percent Monday ahead of news that the company became the first and only oral thin film company to gain a license from the U.S. Drug Enforcement Agency to manufacture pharmaceuticals using both cannabis plant extracts and synthetic cannabidiol.
Pure Sunfarms’ large-scale facility with 16 grow rooms is optimized for year-round production and expected to yield more than 80 harvests annually
FDA accepts study protocol, providing green light for GENFIT to initiate Phase 2 clinical trial in pediatric NASH
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. It blocks interactions with both PD-1 and B7.1 receptors.
The Federal Bureau of Prisons is investigating reports that Pharma Bro Martin Shkreli is using a contraband cellular telephone to continue to call the shots at his former company from prison.