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.
The National Center for Global Health and Medicine (NCGM) and Tokyo Medical and Dental University have divulged 3C-like protease (3CLpro) (SARS-CoV-2) inhibitors reported to be useful for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections (COVID-19).
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.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China's National Medical Products Administration (NMPA) to conduct clinical trials in China with SYH-2055, an oral small-molecule 3C-like protease (3CLpro) inhibitor against SARS-CoV-2.
New research has identified a novel receptor that interacts with the angiotensin-converting enzyme 2 (ACE2) by which the SARS-CoV-2 enters host cells, and shown it can be inhibited with marketed drugs, reducing expression of ACE2 and blocking viral entry.
RSS
