Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA Sciences, Clinical Reference Laboratory.
The issue of the U.S. federal government’s response to the COVID-19 pandemic was revisited yet again in a hearing in the House of Representatives. While partisanship was on full display, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” about the prospects for a vaccine and that the development of candidates has not compromised scientific principles.
Six months to the day that the World Health Organization (WHO) declared it a public health emergency, the SARS-CoV-2 virus, with its hideous red spikes, continues to taunt the world, hopping from host to host and haunting humans, many of whom wonder the same thing: What’s next?
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hai Kang, Philips, Sinapi Biomedical, Truvian.
