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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Last week, HHS Secretary Alex Azar assumed all final authority in deciding new rules regarding food, medical devices and new medications.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 21, 2020.
Johnson & Johnson has become the next big pharma player to be accused in New York State’s Department of Financial Services opioid industry probe.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 18, 2020.
Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, testified yesterday before the U.S. Senate Appropriations subcommittee on labor, health and human services, education and related agencies.
With both autumn and flu season fast approaching, nearly everyone is wondering whether we will endure another round of illnesses that will rival that of last spring.
Arimoclomol will be reviewed under Priority Review with a PDUFA date of March 17, 2021. Here’s more about it.
The National Institutes of Health is raising concern about the safety of AstraZeneca’s coronavirus vaccine, even as the U.S. FDA is weighing whether or not to resume testing in the United States following a global pause in the trial for safety reasons.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.
Only days after saying it expects to have key data from its Phase III clinical trial of its COVID-19 vaccine in October, Germany’s BioNTech received a grant of up to €375 million from the German Federal Ministry of Education and Research.