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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.
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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 July 24, 2020.
Francis Collins, the director of the NIH, told STAT they were “really well-powered, rigorously designed clinical trials.”
“Hopefully the approval process will go very quickly, and we think we have a winner here,” Trump told White House reporters on Wednesday.
The U.S. Food and Drug Administration (FDA) approved Xywav, the first new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years.
Two Chinese nationals have been indicted for hacking into the computer systems of hundreds of companies, governments, non-governmental organizations and more to steal trade secrets, including data on treatments related to COVID-19.
Only days after announcing a COVID-19 vaccine production deal with the UK government, New York-based Pfizer and Germany-based BioNTech signed an even bigger deal with the U.S. government.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 22, 2020.
The trial was initially scheduled for July, but in April had been postponed until October due to the pandemic. A final decision will be made in August.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 20, 2020.
Wrapping up the month of July, there are three PDUFA dates on the U.S. Food and Drug Administration (FDA) calendar.