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 company is pledging to support a goal to end HIV in the U.S. by 2030 announced by the president during the State of the Union this year.
MyoKardia, Inc. reported financial results for the quarter ended March 31, 2019.
Neos Therapeutics, Inc. reported financial results for the first quarter ended March 31, 2019 and provided a business update.
BioArctic’s partner Eisai initiated Phase 3-study with BAN2401 in Alzheimer’s disease.
Expedeon AG reported results for the first quarter ended March 31, 2019.
Assertio Therapeutics, Inc. reported financial results for the quarter ended March 31, 2019, and provided an update on its business performance and strategic initiatives.
TLC announced financial results for the first quarter ended March 31, 2019, and provided a business update.
Esperion provided bempedoic acid franchise development program updates and financial results for the first quarter ended March 31, 2019.
Epigenomics AG announced the financial results for the first quarter of the FY 2019.
Today has been marked by a wide range of life science and biopharma stories. Here’s a broader look at some of the top stories.