Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Allogene, Protega, Remegen, Shorla.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aion, Chimagen, Dr. Falk, Fina, GC Biopharma, GSK, Hopo, Kynos, Ncage, Nvolety, Ryvu, Tikkunlev, Valanx, Vaxxas.
Lexicon Pharmaceuticals Inc. is counting on the Oct. 31 meeting of the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee to help it break through the type 1 diabetes (T1D) door with Zynquista (sotagliflozin), proposed as an adjunct to insulin to improve glycemic control in people with T1D and mild to moderate chronic kidney disease.
While phase II results of Coya Therapeutics Inc.’s low-dose IL-2 drug, COYA-301, showed promise in Alzheimer’s disease patients when dosed every four weeks, it was the more frequent dosing of every two weeks that led to exhausted regulatory T cells and no benefits, driving down the company’s stock by nearly 28%.
With another failure of E-selectin antagonist uproleselan on the books, Glycomimetics Inc. signed an acquisition agreement with privately held, solid tumor-focused Crescent Biopharma Inc., and a syndicate of investors has put up $200 million to make the merger possible. The combined firm will operate under Crescent’s name after the deal closes in the second quarter of 2025, subject to shareholders’ go-ahead.
While there is tremendous enthusiasm for GLP-1 drugs for use in obesity, and 80% of the U.S. population is eligible to use the therapies, tremendous obstacles continue to block their access. The blockages include high prices that consumers currently cannot afford coupled with employer health plans that don’t offer the new treatments. A panel discussing the future of GLP-1s at the BioFuture 2024 conference in New York said the next five years will see enormous changes in the way these drugs are prescribed by physicians and used by patients.
Astellas Pharma Inc. has withdrawn its marketing authorization application from the EMA for its avacincaptad pegol intravitreal solution for the treatment of geographic atrophy secondary to age-related macular degeneration. “The company's decision to withdraw its application followed interactions” with the EMA’s Committee for Medicinal Products for Human Use, an Astellas spokesperson told BioWorld.
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