July 20, 2021

Around the nation: Pfizer-BioNTech's Covid-19 vaccine receives priority review for full approval

Daily Briefing

    FDA grants priority review for full approval to Pfizer-BioNTech's Covid-19 vaccine in today's bite-sized hospital and health industry news from the District of Columbia, Indiana, and Washington. 

    • District of Columbia: FDA on Friday granted priority review for full approval to Pfizer-BioNTech's Covid-19 vaccine. According to Axios, priority review will shorten the approval process from 10 months to six months, and a decision is expected by January 2022. However, Janet Woodcock, FDA's acting commissioner, said the target date for approval does not mean that a decision will not be reached before then. "Quite to the contrary, the review of this [biologics license application] has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the [Prescription Drug User Fee Act] Goal Date," she said in a tweet. If approved, Pfizer-BioNTech's Covid-19 vaccine will be the first to receive full approval. (Frazier, Axios, 7/16; Reuters, 7/16)
    • Indiana: Lutheran Health Network last week announced Scott Teffeteller as its next CEO, effective August 16. Teffeteller was most recently SVP and regional operating officer of Amita Health in the Chicago metropolitan area and president and CEO of Amita Health Resurrection Medical Center Chicago. Before his work at Amita, Teffeteller was president of the east region of Community Health Network. (Gooch, Becker's Hospital Review, 7/16)
    • Washington: Providence on Friday joined Cleveland Clinic and Mount Sinai Health System in deciding not to administer Biogen's Alzheimer's drug, Aduhelm. The health system said it will reevaluate its decision when FDA completes its investigation into the drug's approval and there is more data on Aduhelm's clinical benefit for patients. (Adams, Becker's Hospital Review, 7/16)

     

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