The U.S. FDA’s green lighting of Omeros Corp.’s Yartemlea (narsoplimab) makes it the first approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication of hematopoietic stem cell (HSC) transplantation. The BLA for narsoplimab, a fully human monoclonal antibody that inhibits the enzyme mannan-binding lectin-associated serine protease-2, had a Dec. 26 PDUFA date.
Hanx Biopharmaceuticals (Wuhan) Co., Ltd. raised HK$586 million (US$75.37 million) in its IPO on the Hong Kong Securities Exchange (HKEX:3378) on Dec. 23 to advance its clinical stage immuno-oncology pipeline.
Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab), Merck & Co. Inc.’s reigning blockbuster cancer drug.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Abbisko, Altamira, Astrazeneca, Boehringer, Cytokinetics, Daiichi Sankyo, Gensight, Hansa, Huonslab, Incyte, Kalvista, Merck & Co., Merck KGaA, PTC, Roche, Savara, Viridian.
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