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 inclusion of the list price is part of an effort from the administration to lower the cost of prescription drugs. The industry’s lobbying arm believes the inclusion will be confusing to patients.
Companies from across the globe provide updates to their pipelines and businesses, with news from BioNTech, Mologic, Akcea, RedHill, and more.
MorphoSys AG reports results for the first quarter of 2019.
Retrophin, Inc. reported its first quarter 2019 financial results and provided a corporate update.
Vericel Corporation reported financial results for the first quarter ended March 31, 2019, and recent business highlights.
The Global Health Investment Fund (GHIF) and Medicines Development for Global Health (MDGH) announced the sale of MDGH’s Priority Review Voucher (PRV).
ADL Bionatur Solutions advances the results of selected key performance indicators for the first quarter of 2019 ending March 31, 2019.
Evotec SE will report its financial results for the first quarter of 2019 on Tuesday, 14 May 2019.
PDC*line is a potent, scalable and versatile professional antigen-presenting T-cell with great potential for treating a range of cancers
Strong Crysvita® (burosumab) Launch Continues with Approximately 730 Patients on Reimbursed Commercial Therapy in the United States