Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Elicio, Hoth, Iaso, Innovent, Neoimmunetech, Noven, Ocugen, RDIF, Regeneron, Sanofi, Scpharmaceuticals.
Lexagene Holdings Inc. has successfully configured its Miqlab system to detect the U.K. and South African variants of SARS-CoV-2. The open-access point-of-care system can simultaneously screen for multiple respiratory pathogens and identify COVID-19 strains. Lexagene started studies to support its filing for U.S. FDA emergency use authorization (EUA) in late December 2020. If authorized, it would be the first open-access point-of-care (POC) device to gain an EUA.
COVID-19 vaccine developers should begin testing their vaccines against emerging variants now and assessing booster regimens, the FDA said in an update to its October guidance on emergency use authorizations (EUAs) for the vaccines.
LONDON – The first population-level real-world data on COVID-19 vaccines indicate they are having a dramatic impact on severe disease, with a study in Scotland showing a fall of 85% in hospital admissions for people who received the Pfizer Inc./Biontech SE product, and a drop of 94% for those who had Astrazeneca plc’s vaccine, four weeks after receiving the first dose.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Amgen, Astrazeneca, Brainstorm, Cassava, Celsion, Curocell, Intra-Cellular, Junshi, Supernus, Zosano.
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