The approval by the U.S. FDA in October of Pfizer Inc.’s Velsipity (etrasimod), an oral sphingosine-1-phosphate receptor modulator for moderately-to-severely active ulcerative colitis, brought renewed attention to the inflammatory bowel disease (IBD) landscape, where the hunt goes on for new alternatives. Among the promising soldiers in the march is Paris-based Abivax SA, which closed its IPO the same month.
The Feb. 8 U.S. drug pricing hearing before the Senate Health, Education, Labor and Pensions Committee started out as a spectacle in which Chair Bernie Sanders (I-Vt.) rehashed his usual talking points as he lectured the CEOs of Bristol Myers Squibb Co., Johnson & Johnson and Merck & Co. Inc. about how their companies charge so much more for their drugs in the U.S. than in other countries. But despite the show-trial aspects of the hearing, or what Ranking Member Bill Cassidy (R-La.) called Sanders’ ongoing “CEO-whack-a-mole” agenda, some facts came through that could lead to pricing reforms if Congress has the bipartisan will to do so.
2seventy bio Inc. shares (NASDAQ:TSVT) rose 15% or 52 cents, to close Jan. 30 at $4.01 on word that the Cambridge, Mass.-based firm is selling its R&D pipeline to Regeneron Pharmaceuticals Inc., which will move the work forward by way of a new company called Regeneron Cell Medicines.
No subpoena will be needed to force the CEOs of Johnson & Johnson (J&J) and Merck & Co. Inc. to appear before the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, as apparently the threat was enough to get the CEOs to agree to testify at a committee hearing on U.S. drug prices.
U.S. Sen. Bernie Sanders (I-Vt.), chair of the Health, Education, Labor and Pensions Committee, is not taking no for an answer after the CEOs of Johnson & Johnson (J&J) and Merck & Co. Inc. declined an invitation to appear before the committee to explain their U.S. drug prices.
With one approved myosin inhibitor on the market and another coming up fast, researchers such as those at Tenaya Therapeutics Inc. are casting for new strategies to treat hypertrophic cardiomyopathy (HCM).
Two big pharma firms placed high offers on Dec. 26 to acquire companies focused on radiopharmaceuticals and cell therapies in what Evercore ISI analysts are calling a “good sign for the end of the year.”
Cytokinetics Inc. received a slightly last minute Christmas gift in the form of positive top-line data from the pivotal phase III study of aficamten in treating symptomatic obstructive hypertrophic cardiomyopathy.
Two big pharma firms placed high offers on Dec. 26 to acquire companies focused on radiopharmaceuticals and cell therapies in what Evercore ISI analysts are calling a “good sign for the end of the year.”
Adam Lenkowsky, chief commercial officer for Bristol Myers Squibb Co. (BMS), said his firm plans to launch Karxt (xanomeline-trospium) in the U.S. as soon as it’s approved by the U.S. FDA, and “expect[s] to accumulate sales in early 2025.” BMS tied a bow on the year by disclosing its plan to pay $330 per share to take over Karuna Therapeutics Inc. in a deal valued at $14 billion to bring aboard Karxt, which acts as a dual M1/M4 muscarinic acetylcholine receptor agonist. The FDA has assigned Sept. 26, 2024, as the PDUFA date for Karxt as a new treatment for schizophrenia in adults.
