• STAT+: Pharmalittle: Pfizer asking today for emergency-use status for Covid-19 vaccine; Trump to release drug-pricing rules

    6 days ago - By STAT

    And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is modest, once again. We plan to hang with a short person or two, promenade the spirited official mascot and spend some time in front of the telly. And what about you? This remains a fine time to enjoy the great outdoors. You could stock up on turkey since the holiday is nearing or sound an alarm if you stumble across evidence of election fraud. Perhaps you might reach out to someone feeling isolated. Well, whatever...
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  • Exclusive: Pfizer CEO Discusses Submitting the First COVID-19 Vaccine Clearance Request to the FDA

    6 days ago - By Time

    On Friday, Pfizer CEO and chairman Albert Bourla announced that the company has filed a request to the U.S. Food and Drug Administration for emergency use authorization of its COVID-19 vaccine , making it the first to do so. In a discussion on TIME 100 Talks, Bourla says that if the FDA authorizes the vaccine, the company will be ready “within hours” from receiving the green light to start distributing the vaccine. Pfizer has been manufacturing doses even while safety and efficacy tests were ongoing, in order to avoid delays in shipping once authorized.
    According to Bourla, Pfizer is on...
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  • Pfizer, BioNTech to submit formal application to FDA to authorize Covid-19 vaccine

    6 days ago - By STAT

    The drug maker Pfizer and its German partner BioNTech said they plan to apply Friday to the Food and Drug Administration for an emergency use authorization for their Covid-19 vaccine, a watershed moment in the effort to curb the global pandemic.
    It is unclear how long the FDA will take to review the application, though the agency is expected to move swiftly. Agency officials have pledged to seek advice from an expert panel of outside experts, the Vaccines and Related Biological Products Advisory Committee or VRBPAC , before ruling on the application. VRBPAC members have been asked to hold...
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