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Around the nation: FDA PreCheck program aims to boost US drug manufacturing


Last week, FDA formally launched its new PreCheck pilot program, which aims to help launch domestic pharmaceutical manufacturing facilities more quickly, in today's bite-sized hospital and health industry news from Indiana, Maryland, and Pennsylvania. 

  • Indiana: Late last month, Roche announced positive results from its first late-stage obesity study for its new experimental weight-loss drug. The drug, which is known as CT-388, is a once-weekly injection. During the study, the drug led to a weight loss of 22.5% when adjusting for placebo at 48 weeks. This weight loss was achieved in participants who received the highest dose of the drug, 24 milligrams. Of the participants on this dose, 54% achieved resolution of obesity. "The robust weight loss combined with a well-tolerated safety profile reinforces our confidence in the clinical development programme as we advance to Phase III trials," said Levi Garraway, Roche's CMO and head of global product development. A late-stage clinical trial of CT-388 is expected to start this quarter, and the drug could potentially reach the market by 2028. Roche is also testing other obesity drugs, but they are still in earlier stages of development. (Calatayud, Wall Street Journal, 1/27)
  • Maryland: Last week, FDA formally launched its new PreCheck pilot program, which aims to launch domestic pharmaceutical manufacturing facilities more quickly. The program was originally announced last summer and includes more frequent communication between FDA and manufacturers during the development stages, including facility design, construction, and preproduction. FDA began accepting requests to participate in the program on Feb. 1 and will select an initial cohort of pharmaceutical manufacturing facilities later this year. Facilities will be evaluated on several factors, such as the products they will manufacture, development timelines, and how well they align with U.S. market needs. "After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back," said FDA Commissioner Marty Makary. "The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive." (Jeffries, Becker's Hospital Review, 2/2; Kansteiner, Fierce Pharma, 2/2)
  • Pennsylvania: According to a new analysis from the Center for Healthcare Quality and Payment Reform, 124 rural hospitals have closed or shared plans to close their maternity units since 2020, reducing rural labor and delivery services by 12%. In 2025, 29 rural hospitals closed their maternity units, and three rural hospitals have done the same so far in 2026. Currently, only 41% of rural hospitals still provide labor and delivery services, and in 12 states, fewer than a third of rural hospitals provide maternity care. In the analysis, the researchers found that many of these closures were driven by inadequate payments from both Medicaid and private insurers. Over the last two years, over 100 rural hospitals with labor and delivery services have lost money overall. Because of the closures of these services, many pregnant people have had to travel 50 minutes or longer to reach a hospital with delivery capabilities. People in communities without nearby maternity care also have higher risks of complications and death during childbirth and are less likely to receive adequate prenatal and postpartum care. (Ashley, Becker's Hospital Review, 1/26)

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