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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Joe Rymsza, vice president of Pharmacovigilance and Regulatory Technology Solutions for IQVIA, took time out to discuss trends in PV and regulation in the biopharma industry in the coming year.
As is often the case at the beginning and end of the year, a number of companies announced layoffs. Other news is related to lawsuits and an overall positive story about cancer death rates. Here’s a look.
With a new year underway, the U.S. Food and Drug Administration is doing some house-cleaning of sorts.
The State of California is considering a measure to sell its own brand of generic drugs in an effort to get in on those cost-savings. California’s Gov. Gavin Newsom is expected to reveal the scheme today in his new state budget.
Clinicians and scientists from National Heart Centre Singapore, Duke-NUS Medical School’s Cardiovascular & Metabolic Disorders Programme (CVMD) and SingHealth Duke-NUS Academic Medical Centre (AMC)s’ discovery of a key driver of fibrosis and inflammation in human diseases is now moving rapidly toward the clinic.
A recent study questions if the FDA and other regulatory agencies worldwide rush certain approvals, particularly at the end of the year in a kind of “desk-clearing” activity.
The site location is in Swiftwater, Pennsylvania.
Merck’s checkpoint inhibitor Keytruda (pembrolizumab) continues moving toward the projections of becoming the world’s best-selling drug.
Polyganics announced that it has obtained CE marking for LIQOSEAL®, its easy-to-use and innovative dural sealant patch, and will launch the device in Europe with immediate effect.
Study showed that two metabolic enzymes in the proline metabolic pathway are potential targets to inhibit cancer cell growth, and offers new hope for effective liver cancer treatments