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.
Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection.
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