STAT+: Pharmalittle: We’re reading about 340B battles, new results for a Lilly weight loss drug, and more

The U.S. Food and Drug Administration (FDA) has released draft guidance aimed at simplifying the approval process for individualized gene therapies. This welcome development comes after rare disease advocates have criticized the agency's approach to these treatments, deeming the current requirement for separate drug approval applications for each patient's customized gene therapy to be prohibitively expensive.

The new draft guidance formalizes a "plausible mechanism pathway" and provides more specific rules for licensing and updating gene editing treatments.

Meanwhile, Missouri Attorney General Catherine Hanaway has issued a cease-and-desist letter to drugmaker Eli Lilly, warning the company to halt its practice of requiring hospitals to provide claims data to receive discounted medicines under the federal 340B Drug Pricing Program. Hanaway contends that Lilly has broken its promise to sell its medicines to eligible hospitals in the state and has made "false and misleading statements" while violating state law. Continue to STAT+ for the full story.