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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 20, 2020.
Catalyst Pharmaceuticals has filed new patent infringement lawsuits against Jacobus Pharmaceuticals and PantherRX Rare LLC over a treatment for the rare autoimmune disease Lambert-Eaton Myasthenic Syndrome.
The U.S. FDA granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
The grant was awarded by the U.S. Dept. of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA).
The U.S. Food and Drug Administration has several PDUFA dates for the rest of October, although two of them were already approved. Here’s a look.
The WHO’s SOLIDARITY clinical trial evaluated remdesivir and three other drugs in 11,266 hospitalized COVID-19 patients and found that none of the drugs “substantially affected mortality” or decreased the need to ventilate patients.
Putin touts efficacy and safety of new vaccine without the data to back him up.
Regeneron announced that the U.S. Food and Drug Administration approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children.
This week, the judge overseeing her trial denied all efforts from her legal team to dismiss more than a dozen criminal charges against the Theranos founder.
With multiple COVID-19 vaccines in development, the CDC is confident that any vaccines the FDA authorizes or approves will be safe because they are based on the FDA’s usual stringent protocols. The greater question, after a vaccine is approved, is how it will be distributed.