Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alterity, Apellis, Astellas, Chiesi, CSL, Iveric, Karyopharm, Menarini, Merck, Moderna, Specialised, Teva, Travere, Uniqure.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amniotics, Jasper, Merck, Moderna, NS, Orion, Pfizer, Sarepta, Theriva, Valneva.

Novartis AG has disclosed 3C-like proteinase (3CLpro; Mpro; nsp5) inhibitors reported to be useful for the treatment of SARS-CoV-2 infection.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axcella, Entera, Kancera, Nymox, Ose, Pharming, Redhill.

After gaining emergency regulatory approval in Japan for its oral COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), Shionogi & Co. Ltd. is advancing several global phase III trials across a wide range of COVID-19 patient populations. Branded as Xocova in Japan, ensitrelvir received emergency regulatory approval from Japan’s Ministry of Health, Labour and Welfare in late November 2022 for SARS-CoV-2 infection based on the results from phase II/III trials in non-hospitalized patients in Asia.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Athersys, Avidity, Biocon, Healios, Lemonex, Mirum, Neurona, Soligenix, Verve, Viatris.

Thylacine Biotherapeutics Inc. has entered into a license agreement with Columbia University for worldwide exclusive rights to develop and commercialize a novel antiviral peptide platform invented and refined at Columbia.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acer, Acumen, Akari, Alligator, BMS, Boan, Clene, Dermavant, Ena, Frequency, G1, Gensight, IMV, Luye, Moleculin, Ocular, Recbio, Regenxbio, Scancell, Seelos, Silver Creek, Skye.