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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abiogenix, Alume Biosciences, Aspen Surgical Products, Clait, Fathom, Genfa Medica, Global Institute of Stem Cell Therapy and Research, Kryon, Launchpad Medical, Mediwound, Neovasc, Opus Medical Therapies, Precept Medical Products, Specialty Therapeutics, Venus Medical.
Keeping you up to date on recent developments in cardiology, including: Older siblings’ example turns stem cells into heart cells; Study: High blood pressure meds safe for patients, even during COVID-19 pandemic; COVID-19 spurs fast-tracking of heart, brain health research.
Investors are beginning to show confidence in the financial markets, once again believing that the worst of the ravages caused by the COVID-19 pandemic are behind us and that the stringent restrictions on business activity and personal behavior currently in place will be slowly lifted. As a result, stocks in all sectors rallied in April from their March meltdowns. The Dow Jones Industrial Average recorded an 11.08% increase in the period, its largest one-month percentage gain since January 1987.
With Gilead Sciences Inc. donating its existing stock of finished and unfinished remdesivir to help address the global COVID-19 pandemic through clinical trials, emergency use authorization (EUA) and compassionate use programs, patient accessibility to the investigational drug will be limited by supply, not price.
LONDON – In a potent demonstration of how COVID-19 is transforming the U.K. clinical trial landscape, 47,000 patients have been recruited to studies investigating potential treatments for the infection in a little over two months.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alume, Ascentage, Aspargo, Combioxin, Cytodyn, Freeline, Genetx, Kala, Kempharm, Marinus, Stallergenes Greer, Tolmar, Ultragenyx.
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