The National Institute of Allergy and Infectious Diseases (NIAID) is set to conduct a phase I trial with Tonix Pharmaceuticals Holding Corp.’s TNX-1800 (recombinant horsepox virus, live vaccine), a vaccine candidate to protect against COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, DBV, Hibio, Merck & Co., Novartis, Novavax, Ocular.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Bayer, Blue Water, Globestar, Jaguar, J&J, Locanabio, Kura, Mirati, Prelude, Protagonist, Quadri, Rani, Sangamo, Siren, Smi, Theriva, Tonix.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allyx, Aptose, Aqilion, Coya, Deciphera, Geovax, GSK, Junshi, Leo, Novartis, Novelmed, Reviva, University of Oxford, Volastra, Vyne.
Researchers from Hokkaido University (Japan) and colleagues have identified 2-thiouridine (s2U) as a broad-spectrum antiviral ribonucleoside analogue, by phenotypic screening of a library of 753 nucleoside analogues for antiviral effects. s2U showed antiviral activity against several ssRNA+ viruses, including DENV, SARS-CoV-2 and its variants of concern.
As COVID-19 vaccine development continues, the U.S. FDA is releasing a revised version of its 2020 guidance, “Development and licensure of vaccines to prevent COVID-19.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4SC, Ardelyx, Astrazeneca, Bio4t2, Brainstorm, Caribou, Celularity, Hyloris, Intellia, Mirum, Novavax, Orasis, Sage, Tiziana, UCB, Ymabs.
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