During a massive disaster or a pandemic, securing the necessary manufacturing capacity, needles, syringes, vials, properly labeled caps, reagents and other supplies is as critical as the development of the product itself. Some experts have been warning about these needs since COVID-19 first began spreading outside of China. Now members of Congress are sounding the alarm.
PERTH, Australia – Melbourne, Australia-based Dimerix Ltd. saw its shares gain 66% on the news that its lead candidate, DMX-200, has been chosen to enter the global REMAP-CAP platform trial as a potential treatment for COVID-19-related acute respiratory distress syndrome (ARDS).
Two major papers on repurposed drugs for COVID-19 by researchers from Brigham and Women’s Hospital face intense skepticism from the research community, prompting the editorial boards of TheNew England Journal of Medicine and The Lancet to publish Expressions of Concern on the validity of the underlying data. Such expressions are often the first step toward an outright retraction.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Algernon, Anavex, Can-Fite, Elixirgen.
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.
RSS
