Japan’s Ministry of Health, Labour and Welfare has given Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. the green light for its oral heat shock protein 90 (HSP90) inhibitor Jeselhy (pimitespib) to treat gastrointestinal stromal tumors (GIST) that have progressed after chemotherapy. The company will soon commercialize the drug in Japan.
The U.S. FDA has placed a clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AT-845 following a serious adverse event of peripheral sensory neuropathy in one of the trial participants. AT-845 is an adeno-associated virus (AAV) gene replacement therapy being studied in adults with late-onset Pompe disease.
Astellas Pharma Inc. and Sutro Biopharma Inc. signed an exclusive global licensing deal under which Sutro will develop immunostimulatory antibody-drug conjugates (iADCs) for three biological targets for Astellas.
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye.
While the World Trade Organization (WTO) is taking a victory lap for getting a five-year intellectual property (IP) waiver across the finish line for COVID-19 vaccines, the accomplishment is being panned by spectators on both sides of the track.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: ABVC, Beigene, Biontech, Innovent Biologics, Kazia, Moderna, Novavax, Nrx, Pfizer, Relief.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Basilea, Boehringer Ingelheim, Human Immunology Biosciences, I-Mab, Invicro, Morphosys, Oragenics, Pfizer, Quoin, Telix, Valneva.
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