Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biontech, Blue Lake, Cormedix, CSL, Cynavac, Galapagos, GSK, Hansa, Helsinn, Immorna, Innocare, Medison, Moberg, Moderna, Pfizer, Pipeline, Sanofi, Seqirus, Stealth, Tolerogenixx, UCB, Vir.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axsome, Biosion, Caris, Ebvia, Eloxx, Gain, GB Sciences, Grunenthal, Iama, Jazz, Navrogen, Novaquest, Passage, Prestige, Pyxis, Recce, Relief, Saniona, Taysha, Tyme, Vaxine and Zentalis.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adma, Aquavit, Astrazeneca, Blueprint, Exelixis,
Henlius, Incyte, Janssen, Kyowa Kirin, Mei. Merck, Neuren, Novartis, Roche, Vertex.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzamend Neuro, Aptatargets, Biogen, Canbridge, Icosavax, In8bio, Ionis, Morphic, Novavax, Pipeline, Prothena, Provention, Stalicla, Tiziana Life Sciences.
Top-line interim phase I/II data from Icosavax Inc.’s virus-like particle COVID-19 vaccine fell short of company and market expectations. IVX-411, which displays the SARS-CoV-2 receptor binding domain, was found to be immunogenic and well-tolerated, but the level of immune response was lower than anticipated and inconsistent with data on Icosavax’s platform and its preclinical results.
The FDA continues to issue new and revised emergency use authorizations for testing for the COVID-19 pandemic in recent days, including three reissued and four revised EUAs dated March 24.
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