Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Almirall, Argenx, Ascendis, Astrazeneca, Daiichi Sankyo, Hemogenyx, Iovance, Merck, Moderna, PTC, UCB, Vertex.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Asieris, Biohaven, Coeptis, Edgewise, Scilex, Vincerx.

Research at Medshine Discovery Inc. has led to the development of 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors potentially useful for the treatment of SARS-CoV-2 infection (COVID-19).

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Arcutis, Biontech, Cygenica, Eikon, Gain, Hoth, Moderna, Pfizer.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Acelyrin, Aerami, Aim, Algo, Altimmune, Anokion, Artiva, Arrowhead, Astrazeneca, Avalyn, Curevac, Day One, Dianthus, Foresee, GSK, Humacyte, Hutchmed, IO Biotech, Lisata, Lyra, Mindmed, Myeloid, Neurocrine, Nextcure, Nuvectis, Ose, Replicate, RS Oncology, Sorrento, Sparrow, Valbiotis, Vistagen.

Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Bicycle, Biolinerx, Biosyngen, Day One, Tango, Verona.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atyr, Autobahn, Black Diamond, BMS, Cingulate, Crinetics, Eyepoint, Ideaya, Inflarx, Invivyd, Lassen, MBX, Merck & Co., Neurocrine, Oxford Vaccine, Pepromene, Sinovac, Stealth, Takeda, Urovant, Veru.

If the modification to Regeneron Pharmaceuticals Inc.’s $326 million contract with the U.S. Biomedical Advanced Research and Development Authority is anything to go by, pricing clauses could once again become a common feature in biopharma contracts involving government R&D funding.