Daily Briefing

Around the nation: FDA advisory committee recommends pulling preterm birth drug from market


An FDA advisory committee recommended pulling the preterm birth drug Makena from the market after a confirmatory trial failed to show benefit, in today's bite-sized hospital and health industry news from Maryland, Massachusetts/New Jersey, and Texas.

  • Maryland: An FDA advisory committee recommended pulling the preterm birth drug Makena from the market. Makena was approved via FDA's accelerated approval pathway in 2011 to treat women at risk of giving birth three or more weeks before full-term—but it ultimately failed to show benefit in its 2019 follow-up trial. This is the first time in more than a decade that the agency appears likely to force a drugmaker to stop selling a fast-tracked product. (Jewett, New York Times, 10/19; Whyte, Wall Street Journal, 10/19)
  • Massachusetts/New Jersey: Moderna and Merck are collaborating to develop, manufacture, and sell personalized cancer vaccine candidates. The drugmakers have worked together since 2016, but under a new agreement, Merck will pay Moderna $250 million before the end of 2022's third quarter, and they will equally share costs and profits. "This long-term collaboration combining Merck's expertise in immuno-oncology with Moderna's pioneering mRNA technology has yielded a novel tailored vaccine approach," said Eliav Barr, SVP and head of global clinical development, CMO, at Merck Research Laboratories. "We look forward to working with our colleagues at Moderna to advance mRNA-4157/V940 in combination with KEYTRUDA as it aligns with our strategy to impact early-stage disease." (Twenter, Becker's Hospital Review, 10/12; Moderna press release, 10/12)
  • Texas: Since serving as interim CEO since June, Yasmene McDaniel has been named permanent CEO of HCA Houston Healthcare Southeast. Prior to joining HCA Houston Southeast, McDaniel served as COO at Corpus Christi Medical Center. According to the hospital's website, "McDaniel has cultivated strong relationships with medical staff and community leaders, and has been instrumental in the growth of service lines and provided oversight for multiple facility construction and expansion projects." (HCA Houston Healthcare, accessed 10/20; Kayser, Becker's Hospital Review, 10/19)

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