Neuren Pharmaceuticals Ltd. and Acadia Pharmaceuticals Inc. have expanded their development and commercialization partnership for Daybue (trofinetide) beyond the U.S. to take the Rett syndrome treatment to the world in a deal valued at $527 million plus royalties.
Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement.
Elevar Therapeutics Inc. said that the U.S. FDA accepted its NDA for oral tyrosine kinase inhibitor rivoceranib in combination with PD-1 inhibitor camrelizumab (Airuika) as a first-line treatment for liver cancer. The FDA stamped an official PDUFA target action date of May 16, 2024.
On the heels of a licensing deal last week, Genequantum Healthcare Co. Ltd. has struck another deal, this time out-licensing its conjugation technology to Inxmed Co. Ltd. to support development of next-generation targeted antibody-drug conjugates (ADCs).
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Argenx, Ascentage, Astellas, Astrazeneca, Ausper, Ausperbio, Drug Farm, Harbour, Iaso, Innovent, Invivyd, Kazia, Moderna, Recce, Sihuan, Skyline, Specialised, Transcenta, Xuanzhu, Zai Lab.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Aimed, Alvotech, Amgen, Beigene, Biocon, Biocytogen, Boehringer Ingelheim, Celltrion, Chime, Coherus, Edirna, Fresenius Kabi, Fresenius SE, Genequantum, Hong-Kong King Friend Industry, Huadong Medicine, Innovent, Leaderna, Leads, Lipigon, Meitheal, Organon, Pheon, Remegen, Samsung Bioepis, Sandoz, Sanyou, Shionogi, Sirnaomics, SK Bioscience, Xentria, Zymedi.
China’s Center for Drug Evaluation has cleared Jacobio Pharmaceuticals Group Co. Ltd.’s KRAS G12C inhibitor, glecirasib (JAB-21822), to begin a phase III pivotal study for pancreatic cancer.
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