• FDA will not ‘cut corners' in assessing Covid-19 vaccines, commish says

    1 month ago - By MedCity News

    The agency issued a guidance for industry laying out its various recommendations for vaccine development. The announcement preceded the release of data from Pfizer and BioNTech's Phase I/II clinical trial of their messenger RNA vaccine.
    Read more ...

     

  • Pfizer, BioNTech release preliminary data on Covid-19 vaccine candidate

    Pfizer, BioNTech release preliminary data on Covid-19 vaccine candidate

    1 month ago - By MedCity News

    The data were posted on a preprint server and are currently undergoing peer review for potential publication. The companies anticipate starting a Phase IIb/III study for the vaccine, BNT162b1, this month, pending regulatory approval.
    Read more ...

     

  • STAT Plus: Pharmalittle: FDA sets Covid-19 vaccine guidance; White House grabs much of the remdesivir supply

    STAT Plus: Pharmalittle: FDA sets Covid-19 vaccine guidance; White House grabs much of the remdesivir supply

    1 month ago - By STAT

    Rise and shine, everyone, another busy day is on the way. Yes, indeed, the middle of the week is already here, which means there is much to do. No doubt, you can relate on some level. So please join us as we grab a cup of stimulation - we are sticking with maple bourbon for the moment - and tackle the Zoom and Skype calls that are piling up. Meanwhile, here is the latest grab bag of items of interest to help you along. Hope you conquer the world today, such as it is, and do stay in touch...
    The Food and Drug Administration released guidance for approving a Covid-19 vaccine, saying the...
    Read more ...

     

  • Covid-19 vaccine from Pfizer and BioNTech shows positive results

    1 month ago - By STAT

    An experimental Covid-19 vaccine being developed by the drug giant Pfizer and the biotech firm BioNTech spurred immune responses in healthy patients, but also caused fever and other side effects, especially at higher doses.
    The first clinical data on the vaccine were disclosed Wednesday in a paper released on MedRXiv , a preprint server, meaning it has not yet been peer-reviewed or published in a journal.
    Read more ...