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.
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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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Since reports surfaced that Martin Shkreli used a contraband cellular phone to conduct business from behind bars, the controversial biotech bad boy investor has not been heard from. And it may be because he is currently in solitary confinement.
Representatives from Cigna, CVS, OptumRx, Prime Therapeutics and Humana will meet with Congress regarding prescription drug prices.
Celgene and its developmental partner Acceleron Pharma are eying a potential U.S. Food and Drug Administration approval of a blood-disease treatment.
It is with deep regret that the Agency for Science, Technology and Research announces the passing of Dr Sydney Brenner, Honorary Singapore Citizen, and A*STAR Senior Fellow, early this morning.
The FDA calendar has only one PDUFA data scheduled for the next couple weeks. On Thursday, April 11, the U.S. Food and Drug Administration (FDA) and Merck & Co. have a target action date for their supplemental Biologics License Application (sBLA) for Keytruda
A review of top officials at Memorial Sloan Kettering Cancer Center found that there were repeated violations on financial conflicts of interest. The review was conducted by law firm Debevoise & Plimpton and jointly reported by The New York Times and ProPublica.
“Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important,” stated Bret Miller, founder of the Male Breast Cancer Coalition.
Sino-American relations continue to show signs of strain after the administration of President Donald Trump ordered the Chinese majority owner of healthcare company PatientsLikeMe to sell his stake.
The Pennsylvania-based company disagrees with the FDA’s analysis of its clinical data and will seek to work with the agency for approval.
In January 2019, the U.S. Food and Drug Administration (FDA) updated a 2015 draft guidance on rare diseases.