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 bankruptcy court gave approval to the reimbursement of legal fees for states and local governments involved in the opioid lawsuit settlements, but with the understanding that would allow $200 million in emergency funds to flow to treatment programs.
KidneyX seeks breakthrough solutions to transform kidney care
Oxford Gene Technology, A Sysmex Group Company, is proud to announce that its new facility in Cambridge, UK, has achieved Medical Device Single Audit Program certification of its quality management system
Levo Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation for LV-101 for the treatment of Prader-Willi syndrome Levo is currently enrolling participants in its Phase 3 clinical study of intranasal carbetocin for the treatment of PWS.
On Monday, the U.S. Supreme Court refused to overturn his seven-year conviction for securities fraud.
AbbVie’s blockbuster drug Humira just got another challenger to its share of the market in the United States when its patent expires in 2023.
“The approval of Adakveo marks a new era in the treatment of sickle cell disease, a genetic condition that places an extraordinary burden of unpredictable pain crises on patients and their families,” said Susanne Schaffert, president of Novartis Oncology.
CRO to serve as the Clinical Research Management Support (CROMS)
It is the first BeiGene-discovered drug to be approved.
Management sciences researchers will help agency understand, improve pharmaceutical quality management