Pharm5

Oral treatment for recurrent C Diff, J&J baby powder settlement, Trikafta for 2+ years, and more!

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We’ll be taking a break in May, June, and July while our host is on maternity leave. See you again in August!

 

This week on Pharm5:

  • Vowst (SER-109) for recurrent C Diff
  • Trikafta for CF in 2+ years
  • Mounjaro for weight loss in diabetes
  • Qalsody accelerated approval for ALS
  • J&J talc baby powder settlement

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      References:

      1. FDA approves first orally administered fecal microbiota product for the prevention of recurrence of Clostridioides difficile infection. U.S. Food and Drug Administration. https://bit.ly/3Li7Cue. Published April 26, 2023. Accessed April 27, 2023.
      2. Feuerstadt P, Louie TJ, Lashner B, et al. Ser-109, an oral microbiome therapy for recurrent clostridioides difficile infection. New England Journal of Medicine. 2022;386(3):220-229. doi:10.1056/nejmoa2106516
      3. Vowst [package insert]. Cambridge, MA: Seres Therapeutics, Inc.; 2023.
      4. FDA approves Trikafta for children ages 2 through 5 years with certain CF mutations. Cystic Fibrosis Foundation. https://bit.ly/44dP3QD. Published April 26, 2023. Accessed April 27, 2023.
      5. Lobo A. FDA expands its approval of Trikafta to cover younger children. Cystic Fibrosis News Today. https://bit.ly/3oSuhG0. Published April 27, 2023. Accessed April 27, 2023.
      6. CFTR modulator therapies. Cystic Fibrosis Foundation. https://bit.ly/3Az4epZ. Accessed April 27, 2023.
      7. Lilly's tirzepatide achieved up to 15.7% weight loss in adults with obesity or overweight and type 2 diabetes in surmount-2. Eli Lilly and Company. https://bit.ly/3VkD9AE. Published April 27, 2023. Accessed April 27, 2023.
      8. Galvez-Jiminez N, Goyal NA, Cudkowicz ME. Disease-modifying treatment of amyotrophic lateral sclerosis. UpToDate. http://www.utdol.com. Updated May 17, 2022. Accessed May 19, 2022.
      9. Liu A. FDA awards Biogen's ALS Drug Qalsody an accelerated approval, following its experts' feedback this time. Fierce Pharma. https://bit.ly/3VaVwrC. Published April 25, 2023. Accessed April 27, 2023.
      10. FDA approves Qalsody™ (Tofersen) as the first treatment targeting a genetic cause of ALS. PR Newswire: press release distribution, targeting, monitoring, and marketing. https://bit.ly/3ADSe6N. Published April 25, 2023. Accessed April 27, 2023.
      11. Qalsody [package insert]. Cambridge, MA: Biogen, Inc.; 2023.
      12. J&J to retain all talc-related liabilities from litigation in US, Canada. Reuters. https://bit.ly/3HjTS10. Published April 27, 2023. Accessed April 27, 2023.
      13. Spector M, Knauth D. J&J unit files for second bankruptcy to pursue $8.9 billion talc settlement. Reuters. https://bit.ly/426xfoY. Published April 5, 2023. Accessed April 27, 2023.
        14. ...more
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        Pharm5By Elizabeth B. Hearn, PharmD, BCACP
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