Several South Korean biotech and biopharmaceutical companies completed IND submissions or won nods to start clinical trials in either the U.S. or South Korea, including SK Bioscience Co. Ltd., Genosco Inc., Pimedbio Inc., Sillajen Inc. and Ami Pharm Co. Ltd.
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.
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.
South Korea’s Ministry of Food and Drug Safety approved Moderna Inc.’s Spikevax LP.8.1 vaccine as an updated shot for COVID-19 targeting the LP.8.1 variant, according to Moderna Korea’s announcement Sept. 1. The regulatory clearance comes days after the U.S. FDA accepted, on Aug. 27, Moderna’s supplemental BLAs for two of its COVID-19 vaccines, Spikevax and Mnexspike.
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.
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.
The Medical Device Authority of Malaysia reported on Aug. 22 the piloting of a bilateral medical device approval program with Singapore to streamline the review and launch of medical devices in both countries.
South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.
