PERTH, Australia – Melbourne-headquartered CSL Behring Australia, a subsidiary of CSL Ltd., will begin developing an anti-SARS-CoV-2 plasma product to treat people with serious complications of COVID-19 in Australia.
PARIS – In the wake of the news that Swiss group Roche Holding AG received an emergency use authorization from the U.S. FDA as well as a CE-IVD certification for the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people previously exposed to SARS-CoV-2 that causes the COVID-19 disease, the company unveiled its plans for the launch of the product.
A multi-institutional group led by the University of California at San Francisco’s Quantitative Biosciences Institute (QBI) has identified more than 200 host proteins that interacted with SARS-CoV-2 viral proteins during infection, creating “a blueprint of how SARS-CoV-2 hijacks human cells.”
BEIJING – In one of the latest Sino-foreign collaborations formed to find a cure for the pandemic that has infected 3.5 million people worldwide, Shanghai-based Junshi Biosciences Co. Ltd. and Eli Lilly and Co. have disclosed an agreement to co-develop therapeutic antibodies for preventing and treating COVID-19. Under the terms, Junshi grants Lilly an exclusive license, outside of greater China, to conduct R&D, manufacture and distribute the SARS-CoV-2 JS-016 neutralizing antibodies developed by Junshi.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bio-Rad, Euroimmun, Lifesignals, Nuvasive, Vitalconnect.
LONDON – With COVID-19 infection varying in severity from asymptomatic to lethal the search is now underway for biomarkers to predict which patients are most at risk of suffering severe disease. As one possibility, Menarini Silicon Biosystems (MSB) is using its Cellsearch liquid biopsy technology to capture and count circulating endothelial cells. Meanwhile, Oxford Biodynamics plc is applying its Episwitch platform to find prognostic and predictive epigenetic markers.
The FDA has revised its emergency use authorization (EUA) policy for testing for the COVID-19 pandemic, the impact of which falls principally on serological tests for antibodies generated by the SARS-CoV-2 virus. The agency had previously allowed a commercial antibody test developer to distribute a test without submitting the validation data, but makers of such tests now must forward the validation data to the FDA within 10 days, a move prompted in part by inappropriate claims made by some test developers.
Roche Holding AG, of Basel, Switzerland, has garnered U.S. FDA authorization for emergency use of a test to determine whether people have been infected with the novel coronavirus fueling the COVID-19 pandemic. The Swiss health care giant, which also makes molecular tests to detect active COVID-19 infection, claims its Elecsys Anti-SARS-CoV-2 antibody test accurately identifies COVID-19 antibodies in the blood 100% of the time, 14 days post-infection.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Cerus, Novartis, Roche, Zoll.
