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Latest From Sanofi Pasteur
With coronavirus cases again on the rise in many European countries, members of two EU parliamentary committees asked industry representatives to explain why details of COVID-19 vaccine supply agreements are being kept under wraps.
Takeda will soon seek EU approval of its dengue vaccine candidate. The marketing application will be fast-tracked, as will the applications for Regeneron's evinacumab and bluebird bio's eli-cel Lenti-D gene therapy.
Convalescent plasma has taken another battering as a potential treatment for coronavirus patients, after a UK drug safety body agreed with a US expert panel that there was not yet enough evidence to recommend its use in COVID-19 patients.
The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.