Monoclonal Antibody

Category

U.S. FDA Authorizes Regeneron’s REGN-COV2 Monoclonal Antibody for Emergency Use Authorization Targeting Select COVID-19 Patients

The monoclonal antibody cocktail developed by Regeneron and made well-known by POTUS during his stay at Walter Reed Medical Center has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Initially called REGN-COV-2 and also...

Principal Investigator to COVID-19 Patients in Houston—Best Chance to Access Lilly’s Bamlanivimab Not Under EUA but via BLAZE-1 Study

Eli Lilly’s monoclonal antibody now known as bamlanivimab (formerly LY-CoV555) recently received an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to treat high risk COVID-19 patients. Recently, Houston Methodist physician and...

AstraZeneca selects Lonza as Contract Manufacturer for COVID-19 Long-Acting Antibody Combination Discovered by Vanderbilt Univ. Medical Center

AstraZeneca inked a deal just at the end of October with Swiss contract manufacturer Lonza to produce AZD7442, a combination of two long-acting antibodies (LAABs) for the potential prevention and treatment of COVID-19. The actual antibodies were discovered by...

Monoclonal Antibody Produced by Indian & Cuban Partnership Enters U.S. Clinical Trials Targeting COVID-19 ARDS via San Diego Biotech

A U.S. biotech company called Equillium, Inc. recently received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to commence a Phase 3 clinical trial, referred to as EQUINOX. The company will now investigate itolizumab, a monoclonal antibody...

NIAID ACTIV-3 Study Investigating LY-CoV555 & Remdesivir Placed on Pause: Drug Safety Monitoring Board Move Based on Safety Concern

The ACTIV-3 clinical trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID) and a large group of collaborators, has been paused due to possible safety issues observed by the independent data safety monitoring board (DSMB). This federally...

Lilly, NIAID & Care Access Research Transform How Studies Done to Reach Nursing Homes During COVID-19 Pandemic

On Aug. 3, TrialSite applauded the effort of  Lilly & Co. (NYSE: LLY) and the National Institute of Allergy and Infectious Diseases (NIAID) for the Blaze-2 clinical trial. Why? Because it’s one of the first, if not the first nationwide intervention during the...

Lilly on the Verge of COVID-19 Monoclonal Antibody EUA Approval First for High Risk Patients with Recent Mild-to-Moderate COVID-19 Diagnosis

TrialSite shared that Eli Lilly’s (Lilly) monoclonal antibody program targeting COVID-19 appeared to be working, at least according to some trial site reports. Now Lilly is moving to secure an emergency use authorization for its monotherapy (LY-CoV555) to the U.S....

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