Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Alkeus, Apellis, Astellas, Astrazeneca, Bayer, Belite, Bloomsbury, Boehringer, Cassava, Celldex, Equillium, Faron, Fluoguide, Gannex, Idorsia, Immutep, Inflarx, Innovent, Iveric, Karyopharm, Kodiak, Maat, Mannkind, Moleculin, Moonlake, Neurosense, Nido, Qilu, Regenxbio, Soleno, Sellas, Sunstone, Tonix, Toragen, Vera, Verastem.

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: Antibe, Ashvattha, Cardiol, Clearside, Curocell, Curevac, Cymabay, Dare, Evaxion, Innovative Cellular, Kazia, Merck & Co., Monopar, Silence, Soterios, Springworks, 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.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alnylam, Ascendis, Bioage, Biocryst, Biogen, Biontech, Biovie, Catalym, Dermata, Edgewise, Eisai, IDP, Janssen, Maat, Nkgen, Ocean, Pfizer, Triumvira, Vaccinex, Virion.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Allergan, Aurion, Aviceda, Axsome, Beckley, Psytech, Boehringer Ingelheim, Cymabay, Effector, F2G, Ferring, Genascence, Highfield, Iksuda, Immunomic, Ironwood, Janssen, Leo, Lisata, Maia, Meiragtx, Mereo, Mind Medicine, Moderna, Neurocentrx, Neurotherapia, Nimmune, Oxford, Oxular, Protara, Quoin, Recce, Shanghai Fosun, Shionogi, Sparrow, Therini, Transcode, Upstream, Viking.

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.”