Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Amgen, Astrazeneca, Biohaven, BMS, Calliditas, Diurnal, Eton, Fennec, Humanigen, Iterum, Lantheus, Novo, PCI, Provention, Ryvu, Verrica.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beroni, Cyclerion, Disc, Hunterian, Roche, Sapience, Synbal, Tetra.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antengene, Chiasma, Cstone, Eqrx, Omeros, Tetra, Turning Point, Zai Lab.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioinvent, Dicerna, Eli Lilly, Emmaus, Foresee, Gannex, GSK, Hightide, Intercept, J&J, Legend, Myovant, Ocugen, Pfizer, Seelos, Tarus, Transgene, Vir.
PERTH, Australia – With half the world’s population, Asia Pacific is quickly replacing Europe as the world’s second-largest medical device market, and China, Korea and Australia stand out as leaders, said Tim Schmid, company group chairman for Johnson & Johnson Medical Devices, Asia Pacific, during the recent Ausmedtech 2021 virtual conference.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Advanced Human Imaging, Avicenna.AI, Lantheus, Micro Interventional Devices, Nowdiagnostics.
HONG KONG – Following a wave of concern about the efficacy of two COVID-19 vaccine candidates developed by China National Pharmaceutical Group (Sinopharm), interim analysis of an ongoing phase III trial, published May 26 in the Journal of the American Medical Association, has shown that adults receiving at least one dose of either of the company’s two inactivated SARS-CoV-2 vaccines had significantly reduced the risk of symptomatic COVID-19.
There are now two FDA-backed monoclonal antibody COVID-19 treatments after the agency granted Glaxosmithkline plc (GSK) emergency use authorization (EUA) for single-dose sotrovimab to treat mild to moderate COVID-19 in adults and children as young as 12. Vir Biotechnology Inc. collaborated on the program.
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