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.

From the beginning of the monkeypox outbreak in the U.S. in May, the federal government has bungled the response, according to both Democratic and Republican members of the Senate Health, Education, Labor and Pensions (HELP) Committee.