Lilly announces proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting

– Primary endpoint of viral load change from baseline at day 11 was met for one of three doses; consistent effects of viral reduction seen at earlier time points

– Rate of hospitalizations and ER visits was 1.7 percent (5/302) for LY-CoV555 versus 6 percent (9/150) for placebo–a 72 percent risk reduction in this limited population

– LY-CoV555 was well-tolerated across all doses with no drug-related serious adverse events reported
INDIANAPOLIS, Sept. 16, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of symptomatic COVID-19 in the outpatient setting. The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups (placebo, 700 mg, 2800 mg, and 7000 mg).Continue reading

Lab Tests: ClōSYS Oral Rinse Eliminated COVID-19 Virus up to 98.4% in 30 Seconds

SCOTTSDALE, Ariz. (Aug. 31, 2020) — Rowpar Pharmaceuticals Inc., the makers of the ClōSYS brand of toothpastes, mouthwashes and oral sprays, announced today that an in vitro laboratory analysis showed that ClōSYS Ultra Sensitive Oral Rinse reduced SARS-CoV-2 (COVID-19 virus) up to 98.4% within 30 seconds without the use of any harsh chemicals like alcohol, hydrogen peroxide or povidone iodine.Continue reading

Accelerate Diagnostics Announces FDA Emergency Use Authorization for COVID-19 Antibody Testing System

TUCSON, Ariz., Aug. 18, 2020 /PRNewswire/ — Accelerate Diagnostics, Inc. (NASDAQ: AXDX) and BioCheck, Inc., a privately-held San Francisco-based company focused on in vitro diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and fully-automated MS-Fast instrument.Continue reading

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing

FDA, August 15, 2020:  Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.Continue reading