Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, BMS, Braeburn, Calliditas, Camurus, Daiichi, Innoskel, Mesoblast, Mitotech, Neuvivo, Nkarta, Novavax, Pfizer, Rakuten, Sobi, Verrica, Zai Lab.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Firstkind, Implicity, Roche, Sky Medical Technology.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Fist Assist, Mdoloris, Mindray.
In the face of rare, sometimes fatal, side effects associated with Janssen’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that the agency say it prefers mRNA COVID-19 vaccines over the Janssen vaccine for preventing COVID-19 in those ages 18 years and older.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Boehringer, CSL, Everest, Fate, I-Mab, Incyte, J&J, Laurent, Merck, Nuvation, Sapience, Sobi.
Vaccine specialists Sanofi SA and Glaxosmithkline plc have been behind the curve throughout the pandemic, with upstarts such as Moderna Inc. and Biontech SE stealing the show with their ground-breaking mRNA technology. While their rivals were beginning to launch the first wave of vaccines early last year, Sanofi and GSK had to reformulate theirs after it failed to produce a strong enough immune response in older people. New results show that the shot, SP-0253, could play a role as a booster but there will be another delay after the companies struggled to recruit enough participants in a crucial phase III trial.