The FDA has approved Cobenfy, a dual M1/M4 muscarinic agonist that offers a fundamentally different approach to treating schizophrenia. The fixed dose combination of xanomeline-trospium is the first to act via a novel mechanism for the serious psychiatric disorder in over 50 years, finally expanding the treatment options beyond dopamine-targeted therapies. Bristol Myers Squibb Co., which acquired Cobenfy developer Karuna Therapeutics Inc. for $14 billion in a deal that closed in March 2024, said the drug will be available in the U.S. from late October. Read More
The U.S. FDA’s approval of yet another indication for Dupixent (dupilumab), partnered between Regeneron Pharmaceuticals Inc. and Sanofi SA, could mean another $6.4 billion-plus in sales by the end of the decade. Regulators cleared the drug as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype who are prone to flare-ups. Dupixent, the first-ever biologic for COPD, entered the market in March 2017. Read More
The U.S. FDA has lifted the full clinical hold it imposed in June on Biomea Fusion Inc.’ s phase I/II studies of BMF-219 in types 1 and 2 diabetes. A safety review of the phase IIb expansion study was encouraging and none of the elevated lab values confirmed serious liver injury or impairment, said Biomea’s CEO, Thomas Butler. Read More
Spanish VC firm Asabys Partners has closed its second fund at €180 million (US$201.3 million), to be invested in seed to series B rounds in 12 to 15 biotech, med-tech and digital health companies. Read More
China’s National Medical Products Administration (NMPA) has accepted NDAs for Innovent Biologics Inc.’s IL-23p19 antibody picankibart to treat moderate to severe plaque psoriasis, and Lepu Biopharma’s antibody-drug conjugate MRG-003, to treat recurrent or metastatic nasopharyngeal cancer. Read More
In August 2024, BioWorld tracked 92 clinical trial updates, a decrease from the 121 reported in July. The month included nine successful phase III trials, three with mixed outcomes and three failures. Read More
Capricor Therapeutics Inc. just wrapped up a visit with the U.S. FDA and is prepping to file a BLA in October for its Duchenne muscular dystrophy treatment. Linda Marbán, the company’s CEO, is the guest on the newest BioWorld Insider podcast and she talks about deramiocel (CAP-1002), the company’s allogeneic cardiac-derived cell therapy, for treating the rare disease and how the FDA has made strong efforts in helping lay the groundwork for deramiocel. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Engene, Enanta, Genentech, Inmune, Leo Pharma, Pasithea, Union, Vertex. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acumen, Arch Venture, Biogen, Emergent, Evaxion, Evotec, Genevant, Lonza, Marius, Merck, Mitocarex, Novo Nordisk, Nubioage, Repair Biotechnologies, Sage Therapeutics, Scisparc, Takeda, Tempus AI. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ani, Astrazeneca, Bayer, Biocity, Enterprise, Eydisbio, Innovent, Pharming, PTC, Vertex. Read More
