Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, DBV, Hibio, Merck & Co., Novartis, Novavax, Ocular.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Bayer, Blue Water, Globestar, Jaguar, J&J, Locanabio, Kura, Mirati, Prelude, Protagonist, Quadri, Rani, Sangamo, Siren, Smi, Theriva, Tonix.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allyx, Aptose, Aqilion, Coya, Deciphera, Geovax, GSK, Junshi, Leo, Novartis, Novelmed, Reviva, University of Oxford, Volastra, Vyne.
As COVID-19 vaccine development continues, the U.S. FDA is releasing a revised version of its 2020 guidance, “Development and licensure of vaccines to prevent COVID-19.”