• Indiana: Eli Lilly has agreed to acquire the global rights to MeiraGTx's new gene therapy AAV-AIPL1, which could potentially reverse blindness in children with a rare genetic eye disorder. The therapy was developed to treat Leber congenital amaurosis 4 (LCA4), a genetic condition that involves mutations in the AIPL1 gene, which helps ensure rod and cone photoreceptors function correctly in the eye. Patients with LCA4 either have severe vision impairment at birth or develop it soon after. In a clinical trial of 11 patients, all of them experienced gains in visual acuity in their treated eyes four or more weeks after receiving the gene therapy. They also saw improvements in their functional vision and preservation of the retinal structure. Under the agreement, MeiraGTx will receive a $75 million upfront payment and could receive up to $400 million in milestone payments, including up to $135 million in near-term payments based on regulatory and approval milestones. According to Andrew Adams, Lilly group VP of molecule discovery, ophthalmology is an emerging area of interest for the company. "We are excited to partner with MeiraGTx to bring transformative treatments to patients around the world suffering from eye diseases, starting with AAV-AIPL1, which has shown the unprecedented ability to restore vision in children who were born legally blind," Adams said. (Vinluan, MedCity News, 11/10)
• New York: ByHeart, a company that manufactures organic baby formula, has recalled all its products nationwide amid an ongoing outbreak of infant botulism. So far, at least 15 babies in 12 states have been hospitalized with infant botulism since August, and more cases are currently pending. ByHeart initially only recalled two lots of its products, but later expanded the recall after FDA informed the company of two more cases of infant botulism in babies who had consumed formula that was not part of the first recall. "The FDA's investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions," said ByHeart cofounders Mia Funt and Ron Belldegrun. "Your baby's safety is, and always will be, our biggest priority." According to FDA, the recall is not expected to lead to a nationwide formula shortage since ByHeart's products make up less than 1% of all infant formula sold in the country. (Weixel, The Hill, 11/11; Aleccia, Associated Press, 11/11)
• Pennsylvania: According to new research from the Center for Healthcare Quality and Payment Reform (CHQPR), more rural hospitals have closed or plan to close their labor and delivery units in 2025 compared to 2024. So far this year, there have been 27 completed or planned closures compared to 21 in 2024. It is the second-highest number of closures in a single year after the 34 closures reported in 2023. Since 2020, 116 rural hospitals have closed their labor and delivery units. Nationwide, 950 rural hospitals, or 41% of all rural hospitals, still offer labor and delivery services. However, 127 of these hospitals are at risk of closing due to negative total margins and losses on all patient services over the last two years. With fewer rural hospitals offering labor and delivery services, patients may have to travel far away for an alternative hospital, which could increase the risk of giving complications when giving birth. "Rural maternity care is in a state of crisis, and more women and babies in rural communities will die unnecessarily until the crisis is resolved," CHQPR wrote in the report. (Muoio, Fierce Healthcare, 11/11)

Learn how the dire state of rural healthcare impacts patients and provider organizations, and what can be done to improve access and affordability.