Innovent Biologics Inc. announced June 27 that it gained National Medical Products Administration’s (NMPA) approval of mazdutide as a new weight loss therapy for obese or overweight patients in China. Mazdutide is a dual glucagon/glucagon-like peptide-1 (GCG/GLP-1) receptor agonist originally discovered by Eli Lilly and Co., of Indianapolis.
Abbvie Inc. is shelling out up to $2.1 billion to acquire CAR T player Capstan Therapeutics Inc., gaining rights to a phase I-stage program targeting CD19 as well as an in vivo cell engineering platform. The announcement comes on the heels of recently published data detailing Capstan’s delivery approach using targeted lipid nanoparticles (tLNPs) and marks Abbvie’s latest foray into the CAR T space.
Inmune Bio Inc. claimed a phase II win with TNF inhibitor Xpro (pegipanermin) in early Alzheimer’s disease (AD), though the study missed its primary and secondary endpoints, leading shares of the firm (NASDAQ:INMB) to close at $2.16, down $3.18, or almost 60%.
The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc.
Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Biocity, Carsgen, Emmaus, Pint, Theravance, Viatris.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: CDR-Life, CSL, Hummingbird, Kalvista, Northern Antibiotics, Novartis, Pendopharm, Percheron, Profound, Prokaryotics, Valneva.
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