Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Akebia, Angel, Antengene, Axcella Health, Bharat Biotech International, Biontech, China Oncology Focus, Cocrystal, Coherus, Corvus, Gannex, Immunoforge, Immutep, Impact, Junshi, Merck, Moderna, Novavax, Ocugen, Oramed, Pfizer, RDIF, Recce, Ridgeback, Serum Institute of India, Serum Life Sciences, Sorrento, TFF, Vitti Labs.
Cerecin Inc. has raised $40 million in an oversubscribed round of financing, paving the way for a potential listing in South Korea. Proceeds of the financing will fund the expansion of the company’s current studies and support the planning and initiation of a global phase III study of its lead candidate, tricaprilin, in Alzheimer’s disease.
China’s Center for Drug Evaluation (CDE) released a draft guide on clinical trials of drugs for rare disease as part of an ongoing push to encourage new drug development and nudge developers to focus on biomarkers, pharmacometrics and patient-reported outcomes. Both are needed to continue moving China’s R&D capabilities up the value chain and closer to being on par with the capabilities of other countries that are at the forefront of new drug development.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Algernon, Antengene, Aslan, Astrazeneca, Atreca, Bill & Melinda Gates Foundation, Calithera, Canbridge, China Resources Double-Crane, Daiichi Sankyo, Enanta, Galecto, Histoindex, I-Mab, Immunome, Incyte, Inflarx, Inovio, Legochem, Ligand, Marinomed, Merck, Novavax, Oncodesign, Scriptr Global, Shandong Luoxin Pharmaceutical Group Stock, Shionogi, Specialized Therapeutics Asia, Takeda, Tiumbio, United, Wave Life Sciences.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Alphamab Oncology, Beigene, Biontech, Canbridge, Cstone, I-Mab, Innocare, Johnson & Johnson, Kintor, Moderna, Moleculin, Nanolek, Neuren, Pfizer, Shenzhen Chipscreen.
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