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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Makena, the only FDA-approved treatment to reduce preterm birth failed to meet endpoints in a recent trial. The FDA gave notice of intent to withdraw approval.
Allele Biotechnology and Pharmaceuticals filed lawsuits claiming the companies infringed on Allele’s patented mNeonGreen technology in the development of their COVID-19 treatments.
In the October 2 verdict, Circuit Judge Pauline Newman said that promotional materials, press releases, product catalogs, FDA labels and witness testimony did support the “induced infringement” judgement against Teva.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 6, 2020.
The sticking point for the White House is a provision in the guidance that calls for vaccine manufacturers to follow people participating in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot.
Philadelphia-based software company eResearchTechnology (ERT), which offers software used in hundreds of clinical trials, has suffered a ransomware attack.
The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.
Although October doesn’t appear to be a very busy month for the U.S. Food and Drug Administration’s PDUFA dates, there are a few. Here’s a look at the next two weeks.
At 74 years old, Trump is in a category of older Americans who are at more vulnerable to infection, and at higher risk of developing more serious symptoms.
In mid-August, the FDA’s Oncologic Drugs Advisory Committee voted 9 to 1 to recommend the drug for that indication. Although the agency isn’t required to follow an advisory committee’s recommendation, it usually does.