Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Agios, Astrazeneca, Belite, Biontech, Gilead, Kite, Marengo, Merck & Co., Novavax, Pfizer, Sanofi, Stada, Takeda, Xbrane.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biohaven, Bolden, Coherus, GSK, IDT, Thervance and Valneva.

What was once effective is now a non-starter. Newly updated guidelines from the World Health Organization (WHO) caution against using the COVID-19 treatments sotrovimab, from GSK plc and Vir Biotechnology Inc., and Regen-Cov (casirivimab + imdevimab), from Regeneron Pharmaceuticals Inc. Omicron, the group said, has rendered the monoclonal antibodies ineffective.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cage, Cardurion, Enzolytics, Imara, J Ints, Peptistar, Pharvaris, Quince, Sorrento, Syros, Tagcyx, Twist, and Tyme.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Alnylam, Ascletis, Biojiva, Brainstorm Cell, Bristol Myers Squibb, Celsion, Curevo, Eloxx, Excision, Inhibikase, Navidea, Omeros, Pfizer, Regeneron.

McMaster University has identified antibody-recruiting molecules (ARMs) consisting of human coronavirus (SARS-CoV-2) proteins targeting domain covalently bound to an antibody-binding terminus (recruiting anti-DNP antibodies) through a linker.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Anbogen, Aqualung, ATMA, Avrobio, Atea, Biontech, Centessa, Genfit, Larimar, Mindset, Minoryx, Pfizer, Revive, Spectrum, Syros, Timber, Tracon, Transcenta, Triact.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Alligator, Almirall, Altimmune, Ascendis, Cidara, Effector, Fresh Tracks, Horizon, Locus, MC2, Nascent, NGM, Pfizer, Sagimet, Sensorion.

Immunoprecise Antibodies Ltd.'s subsidiary, Talem Therapeutics LLC, has shared promising results of a new study conducted by the National Institute of Allergy and Infectious Diseases (NIAID) showing continued resilience of Polytope TATX-03 in broadly neutralizing SARS-CoV-2 variants, including two omicron sublineages that had not been previously tested.