Biotechs Working Closely & Feverishly With CDC for COVID-19 Vaccine Development - Seite 3

Co-Diagnostics, Inc. (NASDAQ: CODX) recently announced that its Logix Smart Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2. The Company's test can be used by clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) to detect the presence of the virus that causes COVID-19, and is available for purchase from the Company's Utah-based ISO-13485:2016 certified facility.

Co-Diagnostics began offering its COVID-19 test to some U.S. CLIA labs in March 2020 as a result of the FDA's policy for diagnostic tests for COVID-19 during the current public health emergency. Previously, the Company had initiated sales of its CE-IVD test to the European Community, and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration.

RedHill Biopharma Ltd. (NASDAQ: RDHL) recently announced that it has received authorization from the Italian National Institute for Infectious Diseases and Central Italian Ethics Committee (EC) for an expanded access program (EAP) allowing immediate compassionate use of its investigational drug, opaganib (Yeliva, ABC294640), in Italy for patients with confirmed coronavirus (COVID-19) infection with life-threatening clinical manifestations.

Approximately 160 patients are planned to be treated in three major hospitals in northern Italy, one of the current major epicenters of the pandemic.  "The approved opaganib expanded access program allows physicians in the three major hospitals in Italy to treat patients at high risk of developing pneumonia and those with pneumonia, including acute respiratory distress syndrome, secondary to SARS-CoV-2 infection," said Mark L. Levitt, MD, Ph.D., medical director at RedHill. "RedHill is working diligently to evaluate the potential of opaganib as a treatment for COVID-19 to help patients worldwide in urgent need of a treatment option. I would like to thank our partners at Cosmo Pharmaceuticals for their immense assistance supporting the process in Italy."