Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Abbvie, Abcellera, Alvotech, Aveo, Beigene, Biogen, Biomea, Biontech, BMS, Deciphera, Galapagos, Henlius, Innocare, Janssen, Keymed, Merck, Moderna, Pfizer, Protagonist, Roche.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aicuris, Appili, Arecor, Bayer, Biontech, Edesa, Eiger, Gritstone, Immuno-Cellular, Neurelis, PDS, Pfizer, Synlogic, Tempest, TG, Triumvira, VBL, Vicore.

Nearly 18% of clinical data reported in August were focused on the COVID-19 pandemic, representing the highest percentage for any single month this year. During the month, as the Delta variant took hold throughout the U.S., news of COVID-19 efforts spiked, doubling the amounts seen in both June and July, in which about 9% of the news was pandemic-related, and up significantly from 10% in May.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amivas, Biocryst, Calliditas, Camurus, Cour, GSK, Golden, NFL, Pfizer, Stada, Takeda.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arctic Vision, Astrazeneca, Bio Elpida, Biovaxys Technology, Celsion, Derm-Biome, Enveric, Everest Medicines, Eyenovia, Gilead, Hainan Poly, Intravacc, Luye, Magicmed Industries, Novavax, Sciclone, Sinomab, Suzhou Sinovent, Tarveda.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clene, Elucida, Gritstone, Rottapharm, Takis.

As members of the White House COVID-19 Response Team talk about COVID-19 boosters as if they are a fait accompli for Americans even before the FDA completes its evaluation of the data, the controversy continues to roil around the need for another vaccine dose.