Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Bioacrtic, Eisai, Organon, Pulmovant, Shionogi, Sol-Gel, Zai Lab.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Accro Bioscience, Biocytogen, Fosun, JCR Pharmaceuticals, Ikris, Polpharma, Medipal, Merck, MS Pharma, Novavax, Nuance Pharma, Santhera, Stallergenes Greer, Takeda.
Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).
The Korea Pharmaceutical Traders Association said Aug. 26 that it signed a strategic agreement with Korea Trade Insurance Corp. to support South Korean companies exporting biopharmaceutical materials overseas.
Shanghai Fosun Pharmaceutical (Group) Co. Ltd.’s subsidiary, Shanghai Fosun Pharma Industrial, signed off ex-China rights to a phase II small-molecule inhibitor, FXS-6837, to Sitala Bio Ltd. in a potential $675 million deal.
The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.
Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.
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