One of the big regulatory and pandemic stories of 2022 with global impact was the June 17 World Trade Organization’s (WTO) agreement on a five-year intellectual property (IP) waiver for COVID-19 vaccines and their components.
Everest Medicines Ltd. has achieved a preclinical proof-of-concept milestone for its mRNA rabies vaccine program. This new vaccine candidate for rabies post-exposure prophylaxis was developed in partnership with Providence Therapeutics Holdings Inc. utilizing a clinically validated mRNA technology platform.
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.