The U.S. FDA has posted an immediately-in-effect policy document regarding clinical laboratory development of diagnostics for the pathogen responsible for COVID-19 disease. The agency said the policy allows a lab to use any diagnostic before the FDA has completed an exhaustive review of the test.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anpac Bio-Medical Science, Emit, Medidata, Pillo Health, Pulmodyne, Ra Medical Systems, Nordion, Pelican Engineering, Redhawk, Roche, Sedana, Westinghouse.
Keeping you up to date on recent developments in diagnostics, including: Chest CT bests assays in diagnosing Covid-19; Sweat sensor keeps tabs on stress; Oligodendrocyte-neural connections not just about myelin; Sharper look yields new potential kinase target in ovarian cancer.
Rated the No. 1 most prepared country in the world to tackle an epidemic, the U.S. could see its preparedness put to the test as it responds to the growing COVID-19 outbreak. While the administration is pointing to that rating from a recent global survey to calm fears about the risk in the U.S., the coronavirus emergency is spotlighting cracks in the nation’s preparedness.
LONDON – The COVID-19 epidemic has reached a “decisive point” as the number of new cases in the rest of the world exceeded the number of new cases in China, and seven countries reported infections for the first time.
BEIJING – There was encouraging news when vaccine developer Moderna Inc. announced this week it that has shipped the first vials of its mRNA vaccine against COVID-19 for a phase I trial in the U.S. The vaccine was created just 42 days after the genetic sequence of the COVID-19 virus was released. That is record speed. Other vaccine developers are also working around the clock to respond to the epidemic.
With the CDC saying Tuesday that it’s not if but when COVID-19 becomes more widespread in the U.S., now is not the time to cut the budgets of programs and agencies in the Department of Health and Human Services (HHS).
Nevro Corp.’s stock was up following encouraging results detailed during its fourth-quarter earnings call. Management predicted a positive 2020, highlighting the potential of the U.S. spinal cord stimulation (SCS) market. Keith Grossman, chair, CEO and president of the company, noted that the SCS market slowed last year as a result of stocking issues – a challenge that affected both it and its competitors.
DUBLIN – Could a recombinant human protein drug rejected by Glaxosmithkline plc in 2019 benefit patients with COVID-19 infection? Apeiron Biologics AG disclosed Wednesday Feb. 26 that an investigator-initiated pilot study of APN-01 is getting underway in Guangzhou, China.
BEIJING – While repurposing drugs may be a quick solution to an epidemic like COVID-19 that has a limited research window, it’s just luck as to whether an already available drug candidate exists for newly emergent diseases. Experts say it’s more realistic to develop better drugs instead of attempting to repurpose old ones.
