Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7D Surgical, Abingdon Health, Ethicon, Quest Diagnostics, Seegene.
Keeping you up to date on recent developments in diagnostics, including: Expanding sampling options for COVID-19 could increase testing; Envisia classifier improves IPF diagnosis; Structural study gives insight into plaque formation.
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.”
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