Could REGEN-COV’s New US FDA Emergency Use Authorization Revive COVID-19 Prophylaxis Pipeline?
Regeneron’s neutralizing antibody cocktail earned the first post-exposure prophylaxis EUA for COVID-19, but the new use and dosing improvements need to overcome slow uptake under the original authorization for the COVID-19 treatment and the poisoned environment left by hydroxychloroquine controversies.
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Execs debate how to achieve COVID-fast development of all products; challenges include reforming corporate bureaucracies and getting regulators more funding. Regeneron’s Schleifer says trouble distributing its monoclonal antibodies stemmed from government’s ‘maniacal focus on vaccines.’
The company created two new divisions focused on the new disease areas, bringing in former executives from Bristol Myers Squibb and Sanofi Pasteur.
The UK has pipped the EU to the post in granting a marketing authorization to what the health secretary describes as “a significant addition to our armoury to tackle COVID-19.”