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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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Scientists and physicians have been cautious about use of the drug for the disease, while President Trump touted it as a “game changer.”
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 30, 2020.
Here’s a look at the next two target action dates on the calendar for early April.
A summary of daily biopharma industry news. Please check out stories that are trending on March 27, 2020.
The NDA is for a new formulation of the drug as one-dose granules for oral suspension, would which largely be aimed at children and people who have difficulty swallowing.
Although Zeposia has now been approved in the United States, BMS said it was delaying commercialization due to the “unprecedented COVID-19 pandemic.”
A summary of daily biopharma industry news. Please check out stories that are trending on March 26, 2020.
A day after it was announced remdesivir had received Orphan Drug designation for treatment of COVID-19 from the U.S. Food and Drug Administration, Gilead Sciences submitted a request for the regulatory agency to rescind that offer after an outcry was raised over the potential for exclusivity for the experimental pandemic treatment.
The same day that New York Gov. Andrew Cuomo announced the initiation of a clinical trial using blood plasma from patients who have recovered from COVID-19, the U.S. Food and Drug Administration announced wider support for the practice.
PerkinElmer is the 16th company to receive an EUA for COVID-19 testing.