On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication. Read More
The U.S. FDA issued a complete response letter regarding the BLA for Immunitybio Inc.’s bladder cancer treatment, N-803 (Anktiva), halting the drug’s development and slicing the stock value in half. The problems stem from the FDA’s pre-license inspection of Immunitybio’s third-party contract manufacturing organizations, the company said. It said the FDA also had recommendations for specific chemistry, manufacturing and controls issues and assays that needed to be resolved before the BLA can be approved. Read More
Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease. Read More
Chance Pharmaceuticals Co. Ltd. acquired greater China rights to Inbrija (levodopa inhalation powder), used to manage Parkinson’s disease (PD), from Acorda Therapeutics Inc. in a deal worth as much as $140 million. Read More
A day after grilling top executives from the three largest pharmacy benefit managers (PBMs) in the U.S. about their business practices and the impact they have on prescription drug prices, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 18-3 May 11 to favorably report the bipartisan PBM Reform Act to the full Senate. Read More
Keeping patients at the center of clinical trials is how the global pharma industry views decentralized clinical trials, but bureaucratic red tape from multiple agencies is preventing companies from deploying decentralized trials in South Korea, speakers said during the BIO Korea 2023 conference in Seoul on May 11. Read More
A subcommittee of the U.S. House Ways and Means Committee met to review the status of policies for novel medical devices and drugs, but a partisan rift was immediately evident at the hearing. House Democrats were generally in favor of more drug price negotiation power for the federal government and opposed to immediate Medicare coverage of breakthrough medical devices while Republicans generally steered in the opposite direction, suggesting that drug and device makers should not expect clear legislative sailing over the course of the 118th Congress. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Addex, Alterity, Boehringer, Codagenix, FSD, G1, Genfit, Jaguar Lyndra, Nfl, Oncocross, Transgene, Zealand. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alligator, Angelini, Ariceum, BTG, Geneone, JCR, Itolerance, Kadimastem, Lumen, Orion, Serb, SFJ, UCB. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB, Astrazeneca, Biophytis, Chiesi, Eli Lilly, Hemogenyx, Lighthouse, Minerva, Protalix, Servier, Theravance. Read More
