Full rights to TAK-169, a CD38-targeted engineered toxin body that Takeda Pharmaceuticals Co. and Molecular Templates Inc. have been developing, are going to Molecular Templates as is the therapy’s clinical development.
Janssen Pharmaceuticals Inc. has agreed to pay up to $780 million in up-front, milestone payments and R&D funding for exclusive rights to antiviral conjugates to be developed by Cidara Therapeutics Inc. for the prevention and treatment of seasonal and pandemic influenza.
Acadia Pharmaceuticals Inc. President Serge Stankovic said the company was “kept completely in [the] dark” by the FDA regarding specifics about what the agency found wrong a month ago with the sNDA for Nuplazid (pimavanserin) – until, that is, the agency’s complete response letter (CRL) landed on the firm’s desk.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 89bio, Abbvie, Acadia, Exelixis, Eli Lilly, Passage, Supernus, Tetra.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acea, Advaxis, Amneal, Anixa, Can-Fite, Chinook, Emergent, Johnson & Johnson, Kashiv, Ontochem, Panacea, Sairopa, Sorrento, Teneobio, Vir, Virpax.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeon, Bio-Path, Corbus, Fibrogen, Innovation, Ionis, Teneobio, Uniqure.
The latest global regulatory news, changes and updates affecting biopharma, including: First thrombosis incident reported in Australia; FDA offers guidance on ANDAs during pandemic; FDA revises Moderna EUA; Fed Circuit’s indefinite ruling stands; BMS settles Medicaid rebate claims; GAO refuses to reconsider VA challenge.
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