Policy
The $1.2 trillion budget package will now move to the Senate, which is expected to hold a vote next week.
FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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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
The advisory committee voted 14 to 2 that the benefits of the drug did not outweigh the risks to support approval. The FDA is not obligated to follow the recommendation, but typically do.
The letter outlines multiple failures, including failure to have adequate written procedures for the receipt, identification and handling of raw materials and failure to adequately clean equipment and utensils.