Pfizer is moving swiftly towards an emergency use approval filing, with Moderna not far behind.
Pfizer and BioNTech have completed the Phase III study of their COVID-19 vaccine, and have declared themselves just “days away” from filing final safety and efficacy data with regulators around the world.
The companies announced their first interim analysis from its Phase III trial of mRNA-based vaccine candidate BNT162b2 on 9 November,...
Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.
Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
