Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Antengene, Astrazeneca, Beigene, Biogen, Biontech, Chugai, Codagenix, Cyxone, Daiichi Sankyo, Eisai, Gannex, Henlius, Ix, Open Orphan, Pfizer, Sinovac, Sorrento, Swedish Orphan Biovitrum, Takeda.
Israeli cell therapy specialist Neurogenesis Ltd., said new phase II data has shown that treatment with its autologous cell therapy candidate NG-01 in progressive multiple sclerosis (MS) patients led to an 80% to 90% reduction in disease progression at 12 months compared to a pretreatment period and a 90% reduction in relapses compared to placebo-treated patients.
Chinese biopharma Impact Therapeutics Inc. of Nanjing raised $50 million in a series C+ round on Nov. 30, two years after its $30 million series C round. Impact’s CEO Jun Bao told BioWorld that the majority of the proceeds would be used to take several programs forward. The financing round also paved the way toward an IPO.
HONG KONG – Takeda Pharmaceutical Co. Ltd. received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for an additional indication for its tyrosine kinase inhibitor, Cabometyx (cabozantinib), clearing the firm to manufacture and market 20-mg and 60-mg tablets for patients with unresectable hepatocellular carcinoma that has progressed after prior systemic therapy.
Preclinical startup Tavotek Biotherapeutics Ltd., with operations in Pennsylvania and Suzhou, China, boasts two technology platforms for discovering and developing molecular-targeted biologics for cancers and autoimmune diseases and is working to push its candidates, including a bispecific antibody, to the clinic next year.
RSS
