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.
The emergence of new variants of concern (VOCs) of SARS-CoV-2 may limit the efficacy of monoclonal antibodies and vaccines currently used in the clinic.
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.
Tonix Pharmaceuticals Holding Corp. has exercised an option to obtain an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies for the treatment or prophylaxis of SARS-CoV-2 infection.
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