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 cancer drugmaker pled guilty of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to investigators in federal court.
The U.S. FDA has approved Regeneron and Sanofi’s PD-1 inhibitor Libtayo® for the treatment of patients with advanced basal cell carcinoma with a history of treatment with a hedgehog pathway inhibitor or in patients with advanced BCC who are considered ineligible for an HHI.
The U.S. FDA Oncologic Drugs Advisory Committee voted against recommending the drug as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery, at least for now.
This combination therapy has been authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.
The choice for the new FDA commissioner will tell the public about the Biden administration’s battle plan with regards to handling the global pandemic.
London-based Freeline Therapeutics announced that after receiving feedback from the U.S. Food and Drug Administration (FDA), it was modifying its clinical trial program for FLT180a for Hemophilia B.
A Portland, Oregon biotech consultant is facing two counts of insider trading charges, with federal prosecutors and securities regulators claiming the defendant made profitable stock trades using confidential information he learned during his time consulting for Abeona Therapeutics.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 9, 2021.
Bristol Myers picked up the therapy when it acquired Celgene in 2019 for $74 billion.
The Swiss health authority Swissmedic rejected AstraZeneca’s rolling authorization application for its COVID-19 vaccine a few days ago, saying more data is needed “to obtain more information about safety, efficacy, and quality.”