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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Less than one week after posting a positive first-look at Phase III vaccine data, Maryland-based Novavax began the rolling review process for authorization of NVX-CoV2373 in the United Kingdom, Canada and the United States.
The U.S. Food and Drug Administration (FDA) granted Merck KGaA, Darmstadt, Germany’s Tepmetko (tepotinib) approval for adults with metastatic non-small cell lung cancer (NSCLC) who have a MET exon 14 skipping alteration.
For the pharmaceutical industry, the lack of face-to-face meetings caused the U.S. Food and Drug Administration to implement regulatory workarounds to stay on top of drug and biologics approvals.
Eagle Pharmaceuticals is still struggling to get its generic vasopressin to market, announcing both a regulatory stall and an additional trial delay for a patent case with Endo Par Innovation Company over the drug.
There were two reported cases of trials restarting and one pausing this week. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 2, 2021.
A spirit of urgency and collaboration broke down traditional informational barriers as industry and academia organized like never before in modern history to develop a vaccine in just nine months.
The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (T1D).
February is kicking off with a number of PDUFA dates for the U.S. FDA as well as a cancer advisory committee meeting. Here’s a look.
The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021.