Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alexbio, Amicus, Apellis, Boehringer Ingelheim, CSL Behring, Eli Lilly, Jacobio, Miromatrix, Moderna, Ocugen, Roche, Regeneron, Sanofi, Uniqure, Y-Mabs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aelis, Astellas, Bioved, Cerevel, Equillium, Krystal, Mimivax, Ocugen, Palisade, Skye, Synaptogenix.
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.
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.
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