• District of Columbia: HHS has launched several new initiatives to speed up the development of gene therapies. Last week, FDA published three new draft guidances that outline strategies to help drugmakers streamline the development and approval of drug candidates for rare diseases. The documents promote the use of innovative clinical trial designs, describe pathways for accelerated approval for certain regenerative therapies, and clarify requirements for post-approval safety and efficacy monitoring. Meanwhile, the Advanced Research Projects Agency for Health has launched two new programs designed to increase access to affordable genetic medicines. One program focuses on speeding up the development of one-time precision treatments for genetic diseases while the other provides support for new biomanufacturing technologies to make these treatments faster and cheaper to produce. (Bean, Becker's Hospital Review, 9/25)
• Georgia: According to a new CDC report, infections caused by highly drug-resistant bacteria called NDM-producing carpabenem-resistant Enterobacterales (NDM-CRE) increased by over 460% between 2019 and 2023. NDM-CRE infections are extremely difficult to treat since they are resistant to some of the strongest antibiotics available, CDC said. NDM-CRE infections, which include pneumonia, bloodstream infections, urinary tract infections, and wound infections, are also associated with high morbidity and mortality rates. "This sharp rise in NDM-CRE means we face a growing threat that limits our ability to treat some of the most serious bacterial infections," said Danielle Rankin, an epidemiologist in CDC's division of healthcare quality promotion. "Selecting the right treatment has never been more complicated, so it is vitally important that healthcare providers have access to testing to help them select the proper targeted therapies." To slow the spread of NDM-CRE, CDC urged clinicians to be alert and follow standard precautions, including strict hand hygrine and the use of gowns and gloves during patient care. The agency also recommended healthcare facilities test for NDM-CRE through clinical laboratories or public health labs. (Cerutti, Becker's Clinical Leadership, 9/24)
• Missouri: Earlier this month, Cole County Circuit Judge Daniel Green ruled against a ballot summary for an anti-abortion amendment that would have repealed a constitutional amendment guaranteeing the right to abortion that was adopted by Missouri voters last year. However, Green stopped short of blocking the proposed constitutional amendment from being presented to voters. In his ruling, Green said that the ballot summary did not inform voters that the new measure would repeal the previous constitutional amendment and ordered it to be rewritten. The new measure would repeal the previous constitutional amendment guaranteeing a right to abortion. It would also prohibit gender-affirming care, such as puberty blockers, hormone treatments, and gender transition surgeries for minors, although they are already barred under state law. According to the Associated Press, the proposed amendment will appear on Missouri's ballot in November 2026 unless Gov. Mike Kehoe (R) schedules the vote for an earlier date. (Lieb, Associated Press, 9/19)

The pipeline of cell and gene therapies is expanding in both depth and breadth. Healthcare leaders must adapt as competition grows and innovation stretches into new specialties. Find out how new cell and gene therapies will change the status quo and what it means for providers, purchasers, and pharmaceutical manufacturers.