Russia’s Ministry of Health is looking to extend its role on the global stage. Over the next few months, the ministry, along with other regulatory agencies in Russia, said it plans to start the accreditation process of coming into compliance with World Health Organization (WHO) standards.
During the most infectious COVID-19 month since the pandemic began, January recorded an increase of 82.3 million confirmed cases worldwide, an amount that is fourfold the average monthly increase over the past year. It comes at a time when the highly transmissible omicron variant continues to circulate, bolstered by a new subvariant, BA.2, which is outcompeting its predecessor. Meanwhile, regulatory agencies are authorizing antivirals, swapping monoclonal antibodies based on their efficacy against omicron, and approving new vaccine options, including Novavax Inc.’s protein-based vaccine Nuvaxovid (NVX-CoV2373).
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.
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