Can The COVID Approach Be Used For Other Therapeutics? FDA Speed Is Factor, Pfizer’s Bourla Says
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.’
You may also be interested in...
India saw a raft of vaccine and drug approvals in 2021, backed by pandemic-related accelerated regulatory processes, and outlined its intent to step up biopharma innovation in the country. Pharma wants some of the regulatory flexibility to stay, though experts are seeking increased transparency in the overall approach.
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.
Pfizer CEO Albert Bourla said he is disappointed in the US politicization of a COVID-19 vaccine in a letter to employees. ‘We are moving at the speed of science,’ he said.