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.
Scientists at the University of Sydney have discovered a protein in the lung that blocks SARS-CoV-2 infection and forms a natural protective barrier in the human body. Leucine-rich repeat-containing protein 15 (LRRC15) is an inbuilt receptor that binds the SARS-CoV-2 virus without passing on the infection. The discovery opens a new area of immunology research around LRRC15 and suggests a pathway to develop new drugs to prevent viral infection from coronaviruses like COVID-19, but also to deal with fibrosis in the lungs.