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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Now that July has come and gone, the U.S. Food and Drug Administration is back to work approving drugs. This week marks three PDUFA target action dates, although one has already been rejected and another hit a snag that doesn’t appear to affect the decision date.
Before it finalizes the guidance, the FDA is seeking comment from drugmakers about the proposed plans.
This is an area where the U.S. is considering changes as well. Earlier this year, the U.S. Department of Health and Human Services proposed a new policy called the International Pricing Index.
Sareum Holdings PLC, the specialist small molecule drug development business notes that Sierra Oncology, the licence holder advancing clinical cancer candidate SRA737, has announced its financial and operational results for the second quarter 2019 ended 30 June 2019.
Esperion provided bempedoic acid franchise development program updates and financial results for the second quarter ended June 30, 2019.
Neos Therapeutics, Inc. reported financial results for the second quarter ended June 30, 2019 and provided a business update.
Researchers from Singapore and the United States are focused on a novel drug candidate with marine origins as a new method to prevent or treat vision loss.
Catalyst Pharmaceuticals, Inc. reported financial results for the second quarter ended June 30, 2019 and provided a corporate update.
Global Blood Therapeutics, Inc. reported recent business progress and financial results for the second quarter ended June 30, 2019.
Vericel Corporation reported financial results for the second quarter ended June 30, 2019, and recent business highlights.