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 U.S. Food and Drug Administration approved the first blood test that looks for the antibodies against the novel coronavirus that causes COVID-19.
With all the similarities, it should be emphasized that there are several significant differences between the two pandemics.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 2, 2020.
On Wednesday, the judge overseeing Holmes’ case set for late July refused to change the trial date after her defense team made the request.
Following months of concerns regarding the potential contamination of ranitidine-based products with known carcinogens, the U.S. Food and Drug Administration is asking manufacturers to immediately withdraw all prescription and over-the-counter drugs from the market.
The U.S. Food and Drug Administration is expediting the development of novel therapies for the pandemic through an accelerated evaluation process.
In a statement, the FDA said “objectionable conditions were found and documented” but did not meet the threshold for regulatory action against the Swiss pharma giant.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 1, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 31, 2020.
On Monday, a judge ruled against patents blocking the way for generic drugmakers Hikma Pharmaceuticals and Dr. Reddy’s Laboratories to file Abbreviated New Drug Applications for Vascepa generics.