The FDA has issued an emergency use authorization (EUA) for Becton, Dickinson & Co.’s (BD) Veritor At-Home COVID-19 test – a rapid COVID-19 digital antigen test. The test, which is designed for home use, uses a mobile app from Los Angeles-based Scanwell Health Inc. that provides instructions on how to collect and transfer the nasal swab sample to the test stick. The smartphone camera is then used to capture, analyze and interpret results within 15 minutes. BD said it will initially be rolled out to businesses, schools and governments looking to provide a self-testing option.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Microtransponder.
A fully approved COVID-19 vaccine, clinical advances of pandemic antibodies and multibillion-dollar deals appear to be the driving forces of increasing biopharma stock prices. BioWorld’s Biopharmaceutical Index is tracking ahead by 10.6% this year, after several months of negative numbers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Ascendis, Astrazeneca, Biocryst, Biontech, Exelixis, Ironwood, Marinus, Merck, Ono, Pfizer, Scancell, Servier, Sesen, Takeda, Vertex, Zogenix.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acasti, Alpha Healthcare Acquisition, Beigene, Bio-Thera Solutions, Bolt, Grace, Hikma, Humacyte, Immix, Innovent.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amneal, Astrazeneca, Edesa, Everest, Hutchmed, Inmune, Ose, Pardes, Ryvu, Servier, Turn.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioventus, Johns Hopkins University, Merck, Millar, Ontada, Schwarzer Cardiotek, Todos Medical, Trice Medical, University of Washington School of Medicine.
With the Americas having the dubious distinction of the most COVID-19 cases in the world, the Pan American Health Organization (PAHO) is answering that “wake-up call” with plans to develop a collaborative platform to develop mRNA vaccine production in Latin America and the Caribbean.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerami, Argenx, Blade, CTI, Moderna, RDIF, Taysha.
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