Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Bioxytran, Eva, Exicure, Harrow Ipsen, Lilly.
Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), scored emergency regulatory approval from Japan’s Ministry of Health, Labor and Welfare for SARS-CoV-2 infection, and the Japanese government has agreed to purchase 1 million courses of Xocova for domestic supply of the antiviral.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainstorm, Evergreen, Galera, Ideaya, Janssen, Medivir, Pfizer, Recce, Sobi, Vertex.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Asieris, Astrazeneca, Biosion, Calidi, Calliditas, Glycotope, Immunogen, Lantern, Sosei, Therabest, Viatris, Zyversa.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Antengene, Biogen, Braeburn, Janssen, Pfizer, Recce.
Vaxxas Pty. Ltd. raised AU$34 million (US$23 million) to advance its needle-free COVID-19 vaccine program, which began in early November, and readouts from the study are expected in late February or early March, Vaxxas CEO David Hoey told BioWorld. The COVID-19 vaccine patch is based on the company’s high-density microarray patch technology that delivers Hexapro, a second-generation version of the spike protein used in all major U.S.-approved COVID-19 vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akero, Bioxytran, Bloomsbury Genetic, Brim, Cerecin, Emmaus, In8bio, Liscure, Moderna, Molecular Targeting, Numinus, Quralis, Takeda, VBI, Visiox, Y-mabs.
China recently approved four COVID-19 vaccines for emergency use in a span of two days. The nods were granted to Clover Biopharmaceuticals Ltd., Sinocelltech Group Ltd., Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. and Westvac Biopharma Co. Ltd. There is still no mRNA vaccine approved in the country.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Ascletis, Delta-Fly, Moleculin, Novavax, Oncopeptides, Qualigen, Sionna.