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The FDA issued straight-to-final guidance that provides sponsors of monoclonal antibody and other therapeutic protein COVID-19 treatments with recommendations for potency assays to ensure consistent product quality. Read More
French vaccine company Valneva said it has begun production of its investigational COVID-19 vaccine, which is now in a phase 1/2 clinical trial in the UK. Read More
Johnson & Johnson is expected to file for Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine this week, but the much-needed shot has shown to be significantly less effective than its Pfizer/BioNTech and Moderna counterparts and looks to have problems tackling the virus’ highly contagious South African variant. Read More
Researchers from Pfizer and the University of Texas Medical Branch have found that the Pfizer/BioNTech COVID-19 vaccine was still able to effectively neutralize key mutations in the highly contagious UK and South African coronavirus strains, offering hope that the prominent vaccine won’t need to be readjusted at this point. Read More
A new study has found that Eli Lilly and Regeneron may need to adjust their monoclonal antibody treatments to effectively fight fast-spreading COVID-19 variants, especially the South African mutation, which along with a UK variant has raised concerns among scientists that SARS-CoV-2 may mutate to resist vaccines and treatments. Read More
In what looks like a breakthrough for COVID-19 treatments, Regeneron’s monoclonal antibody cocktail REGEN-COV (casirivimab and imdevimab) cut infection rates in half and provided full protection against symptomatic COVID-19, according to interim results from a phase 3 trial evaluating the treatment as a passive vaccine. Read More