Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Altimmune, Celltrion, Cybin, Eagle, Filament, Genentech, Immunoprecise, Janssen, Kite, Nordic, Novelmed, Reata, Regeneron, Sanofi, Veru, Viridian.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Can-Fite, Madrigal, Scancell, Shionogi, Taysha, Viracta.
LONDON – A new SARS-CoV-2 sub-variant is showing signs of outcompeting the omicron variant that was first reported in South Africa in late November 2021, and within a month had taken over from its delta predecessor, accounting for 98.8 % of sequenced cases worldwide, as of Jan.25.
Moderna Inc. reached a milestone of sorts Jan. 31 as the U.S. FDA fully approved its COVID-19 vaccine, Spikevax (elasomeran), for use in adults. Meanwhile, the Moderna and Pfizer Inc.-Biontech SE vaccines are in the sights of the U.S. Congressional Progressive Caucus, which is pushing the Biden administration to do more to ensure global vaccination.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Alx, Amryt, Beigene, Bioheng, Biontech, Blueprint, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Pfizer, Provention, Regeneron, Sanofi.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dizal, GBT, Merck & Co., Pfizer, Sellas, Trevena.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bergenbio, Cognito, Cybin, Merck, MSN, Neurosense, Novavax, Nrx, Ostentus, PDS, Ridgeback, Vanda.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioventix, Fluxion, FX Solutions, Materacor, Medtronic, Perceptive Solutions, Titan Medical.