Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Advaccine, Ascletis, Astrazeneca, Autolus, Bluebird, Biohaven, Calliditas, Dare, Eton, Inovio, Moderna, Relief, Sanofi, Yisheng.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Qiagen, Spintech.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Athersys, Dicerna, Healios, Innovent, Neurocrine.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adhera, Hillevax, J&J, Melior, Neopharm, NRG, Protagonist, Rhythm, Siga, Takeda, Urogen, Zandcell.
Novavax Inc. now says it plans to submit an emergency use authorization (EUA) to the FDA for its highly efficacious COVID-19 vaccine, NVX-CoV2373, sometime in the fourth quarter, backing off previous plans of a second-quarter and then a third-quarter filing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Certest Biotech.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apexigen, China Pharma, Eiger, Everest, Exelixis, Merck, Therapeutic Solutions.