Top of the morning to you. Blue skies, cool breezes, and plenty of chirping birds are enveloping the comfy Pharmalot campus, which is cause to fire up the trusty coffee kettle for a needed cup of stimulation, and we invite you to join us. Remember, a prescription is not required. Our choice today is the seasonal pumpkin spice. Predictable, yes, but also delicious. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. … The U.S. Food and Drug Administration published draft guidance that would streamline approvals of some individualized gene therapies, a win for rare disease advocates who have criticized the agency approach to these treatments, STAT says. The FDA has continued to require companies to submit separate drug approval applications for each patient’s customized gene therapy, even when they use fundamentally the same approach to target different genes. Advocates argue this creates a prohibitively expensive regulatory burden. The new draft guidance formalizes a “plausible mechanism pathway,” and offers more specific rules for licensing and updating gene editing treatments. Missouri Attorney General Catherine Hanaway warned Eli Lilly to discontinue its practice of requiring hospitals to provide claims data to receive discounted medicines under a federal program, a sign that more states are pushing back against such moves by drugmakers, STAT notes. In an Oct. 26 cease-and-desist letter sent to the company, Hanaway maintained that Lilly has “broken” its promise to sell its medicines under the 340B Drug Pricing Program to eligible hospitals in the state. As a result, she contended the drugmaker has made “false and misleading statements” and violated state law. Continue to STAT+ to read the full story…
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