• STAT+: Pharmalittle: FDA scolds Catalent over quality control at plant making Covid shots; Novartis will ask SCOTUS to protect a key patent

    13 days ago - By STAT

    Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is maple cinnamon French toast, a yummy concoction that has quickly become one of our favorites. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch. We are always happy to make...
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  • STAT+: Catalent is scolded by FDA for quality control issues at a plant that helps make Covid-19 vaccines

    13 days ago - By STAT

    Catalent, one of the largest contract manufacturers in the pharmaceutical industry, was cited by the U.S. Food and Drug Administration for a series of quality control failures at a facility in Bloomington, Ind., the same plant where the company helps produce two Covid-19 vaccines. The issues prompted the agency to delay distribution of Moderna booster shots, although their release has now reportedly been authorized.
    Following a recent month-long inspection, the agency scolded Catalent for various problems, such as failing to investigate unexplained discrepancies in batches of products and...
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