Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Medtronic, Opti Medical Systems.
LONDON – After all the controversy and a huge dose of hype, there is no clinical benefit from the use of hydroxychloroquine in patients admitted to the hospital with COVID-19, according to headline data from a large randomized trial of potential drugs for the infection currently running in the U.K.
The latest U.S. FDA town hall for testing for the COVID-19 included a few updates on serological testing, but perhaps the most important take-away was when Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiology, advised attendees that performance expectations regarding next-generation sequence (NGS) testing for the SARS-CoV-2 virus will closely resemble those of conventional molecular testing.
Hesperos Inc.'s Human-on-a-Chip in vitro system demonstrated two types of responses of the immune system in a study conducted with Hoffman-La Roche Pharmaceuticals and the University of Central Florida.
As more COVID-19 antibody testing becomes available, one question has been on everybody’s mind: Does the presence of antibodies to SARS-CoV-2, the virus responsible for the global pandemic, mean that people are protected from future infection? To that end, Genscript Biotech Corp., of Piscataway, N.J., has applied for emergency use authorization (EUA) with the U.S. FDA to market a test that specifically recognizes neutralizing antibodies to SARS-CoV-2.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avita Medical, Citius, College Park Industries, Fibralign, Icometrix, Lumendi, Medx, Mölab, Mybio, Myndtec, Maness Veteran Medical, Nuprobe, Ourcrowd, Pathgroup, Protech Home Medical, Qualigen Therapeutics, Respira Technologies, Steeper Group, Surgery Exchange, Technopath Clinical Diagnostics, Terumo.
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.
Eli Lilly and Co. said June 1 the first patients have been dosed in a phase I test of LY-CoV555, a potential antibody treatment for COVID-19, with results expected by June 30. Should it prove safe, the candidate could quickly move into a phase II trial to assess its efficacy, Ajay Nirula, vice president of immunology at Lilly, told BioWorld.
