Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Arcutis, Biontech, Cygenica, Eikon, Gain, Hoth, Moderna, Pfizer.
Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Bicycle, Biolinerx, Biosyngen, Day One, Tango, Verona.
If the modification to Regeneron Pharmaceuticals Inc.’s $326 million contract with the U.S. Biomedical Advanced Research and Development Authority is anything to go by, pricing clauses could once again become a common feature in biopharma contracts involving government R&D funding.
South Korean biopharmaceutical firms are facing a harsher climate and an uphill battle both domestically and abroad, amid the larger economic downturn that has slowed everything from new drug approval to dealmaking. At the Global Pharma Key Opinion Leaders (GPKOL) 2023 Symposium held at the El Tower on Sept. 7 in Seocho-gu, Seoul, officials from the industry, government and academia gathered to discuss strategies on bouncing back from the lasting effects of the COVID-19 pandemic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Aspargo, Astrazeneca, CSL, Inmune, Italfarmaco, Krystal, Nykode, Uniqure, Viatris, Wave, X4.
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