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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Moberg, Morphosys, Novavax, Phanes, Secura, Silence, TC, Xcovery.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allogene, Biodelivery, Bullfrog, Collegium, Neonmind, Quretech, Vaxxas, Vectivbio.
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Atrogi, Calliditas, Cansino, Marinus, Merck, Orphazyme, Palisade, Takeda.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: BMS,Merck, Oragenics, Pfizer, Pharmacyte, Pharvaris, Philochem, Philogen, Transcenta.
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