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The U.S. FDA has nudged the emergency use authorization (EUA) program forward once again, this time with a template for applications for tests that can be performed entirely at home, in the office and at schools. FDA Commissioner Stephen Hahn said in an accompanying statement that tests of this sort “will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”
VANCOUVER – Sorrento Therapeutics Inc., which is working to build a comprehensive lineup of COVID-19 products, has in-licensed a self-contained test for SARS-CoV-2 that may produce accurate results in half an hour.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Arthrex, Image Processing Technologies, Smith & Nephew.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hai Kang, Philips, Sinapi Biomedical, Truvian.
Senhwa Biosciences Inc., of Taipei, Taiwan, said casein kinase 2 (CK2) is the right target to aim at when developing a COVID-19 therapeutic treatment. The company’s silmitasertib is the only clinical-stage inhibitor of CK2, a kinase recently identified by researchers as being hijacked by SARS-CoV-2.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Inovio, Melt, Merck, Novartis, Regulus, Relief, Ridgeback, Roche, Scynexis, Teva.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Auris, Constant, Denali, Dimerix, Genentech, Krystal, Repare, Samus, Sanofi.
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