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The Food and Drug Administration published draft guidance on Tuesday that would streamline approvals of some individualized gene therapies, a win for rare disease advocates who have criticized the agency’s approach to these treatments. (Manto, 10/27)

Missouri Attorney General Catherine Hanaway (R) has 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. (Silverman, 10/27)

Artiva Biotherapeutics said Tuesday that it’s winding down after two patients died in a trial testing its cell therapy for autoimmune diseases, the latest in a series of safety events that have emerged in a promising research field. (Chen, 10/27)

An investigational Lyme disease vaccine covering six serotypes across four Borrelia species had a vaccine efficacy (VE) rate of over 70%, but it just missed a preset noninferiority threshold, a placebo-controlled phase III trial showed. (Rudd, 10/27)

The investigational Bruton's tyrosine kinase (BTK) inhibitor fenebrutinib may curb chronic active lesions in multiple sclerosis (MS), data from phase III trials suggested. (George, 10/27)