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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bittium, Quantumdx.
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.
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