Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alafair Biosciences, Assure Tech, Quadrant Biosciences, Vela Diagnostics.
LONDON – The U.K. will become the first country to stage a human challenge trial in which volunteers are deliberately infected with SARS-CoV-2, as a fast route to assessing the effectiveness of COVID-19 vaccines, and to build understanding of what an effective immune response looks like. The contract research organization Open Orphan plc said it is in advanced negotiations with the U.K. government and other partners for the studies, which are expected to be formally announced next week.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA stands by plasma EUA; Benzodiazepines to get added warnings; EMA posts draft guidance for registry-based studies; SEC finalizes whistleblower changes; Gilead to pay $97M; Plandai, CEO settle with SEC.
Two studies seek to answer the most pressing question for physicians examining a patient with COVID-19: What's this person's risk of death? Mount Sinai researchers presented their clinical prediction model in The Lancet Digital Health and a team from Johns Hopkins published their risk calculator in the Annals of Internal Medicine.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accenture, Angle, Ardigen, Bioclinica, Caresafely, Change Healthcare, Cpsi, Ebamed, GI Reviewers, Longitude Capital, Medtronic, Quadvantage Technologies, Royal Philips, Thermo Fisher Scientific, Think Surgical, Total Joint Orthopedics.
Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.
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