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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Reckitt Benckiser spun Indivior off into a standalone company in 2014. Earlier this year the Department of Justice charged Indivior for its role in the opioid crisis.
Global, unaudited sales of HEMOBLAST™ Bellows for the first half of 2019 were €1.4 million – on track to achieve 2019 revenue guidance range of €4.0-4.5 million; projection for 15% market share in the US and main European countries remains a long-term goal
The FDA approval marks the first drug approved for Azurity, a company formed from the merger of CutistPharma and Silvergate.
The U.S. Centers for Disease Control and Prevention published research in the journal Lancet Infectious Diseases outlining the results from two experimental Ebola drugs, Gilead Sciences’ remdesivir and Mapp Biopharmaceutical’s ZMapp. Both successfully inhibited the growth of the virus in human cells in laboratory studies.
Nephros, Inc., a commercial-stage company that develops and sells high performance water purification products to the medical device and commercial markets, announced preliminary financial results for the quarter ended June 30, 2019.
Inspire Medical Systems, Inc., a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea, announced that it will release financial results for the second quarter 2019 after the close of trading on Tuesday, August 6.
Reston Hospital Center has received the American Heart Association/American Stroke Association’s Get With The Guidelines® Target: Stroke Honor Roll Elite Gold Plus Quality Achievement Award.
Biofrontera AG, an international biopharmaceutical company, reports preliminary unaudited revenue for the first six months of fiscal year 2019.
Cellectar Biosciences, Inc. announced the U.S. Food and Drug Administration has granted Fast Track Designation for CLR 131 in relapsed or refractory Diffuse Large B-Cell Lymphoma.
CorMedix Inc. announced that it has received feedback from the U.S. FDA regarding the submitted statistical analyses of data and additional information requested by the FDA for the primary and secondary efficacy endpoints of the Company’s LOCK-IT-100 clinical study.