In a letter to the hemophilia community, Pfizer Inc. reported a death due to cerebellar infarction and subsequent cerebral hemorrhage in a long-term extension trial participant taking the New York-based company’s tissue factor pathway inhibitor antagonist Hympavzi (marstacimab).
After being unanimously passed by the U.S. House Dec. 1, the bipartisan Mikaela Naylon Give Kids a Chance Act seemed to be headed for sure passage in the Senate before it adjourned late last week.
Abbisko Therapeutics Co. Ltd. and its partner Merck KGaA got an early Christmas present from China’s National Medical Products Administration (NMPA) with the approval of pimicotinib (ABSK-021), the first domestically developed systemic therapy for tenosynovial giant cell tumor (TGCT).
Six individuals, including an investment banker, face multiple U.S. charges stemming from an alleged $41 million insider-trading scheme, plus stock manipulation schemes involving biopharma companies. The charges are related to three overlapping securities fraud schemes that occurred between June 2020 and February 2024.
Shionogi & Co. Ltd. will acquire global rights to U.S. FDA approved amyotrophic lateral sclerosis therapy edaravone through a $2.5 billion acquisition deal with Tanabe Pharma Corp. Under the terms, Tanabe will form a new entity harboring both oral and intravenous (I.V.) infusion formulations of edaravone that are marketed in the U.S. as Radicava ORS and I.V. Radicava.
Needle-phobic obesity patients got their first workaround with the U.S. FDA clearance of Novo Nordisk A/S’ once-daily GLP-1 Wegovy (semaglutide) pill, the first of its kind.
Reviva Pharmaceuticals Holdings Inc. may be headed back to the clinic for another phase III study of brilaroxazine in treating schizophrenia. With a successful series of early and mid-stage studies behind the treatment, the U.S. FDA recommended a second study for the serotonin-dopamine and neuroinflammatory signaling modulator after a pre-NDA meeting in order to net more efficacy results and expand the safety dataset.
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