By filing an IND with the FDA to initiate a phase II/III study of EB-05, a monoclonal antibody, Edesa Biotech Inc. joined the handful of companies developing COVID-19 treatments that inhibit Toll-like receptor 4 (TLR4) signaling. The Toronto-based company’s stock (NASDAQ:EDSA) responded by rocketing 81.38% upward Thursday to close at $9.45, after trading as high as $19.10.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affinity, Altum, American Gene Technologies, Appili, Betterlife, Cerevel, FSD, Gen1e, Inovio, Johnson & Johnson, Neurotrope, Nichi-Iko, Pharvaris, PDL, Takeda, Teva, Worldwide Clinical Trials.
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.
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