Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Details Plans For Quicker Approvals Of Some Individualized Gene Therapies
Stat: FDA Releases Draft Guidance On Individualized Gene Therapy Approvals
The Food and Drug Administration published draft guidance on Tuesday that would streamline approvals of some individualized gene therapies, a win for rare disease advocates who have criticized the agency’s approach to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)
Stat: Missouri AG Pushes Back On Lilly's 340B Data Demands
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)
Stat: Artiva Therapeutics Shutting Down After 2 Clinical Trial Deaths
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)
MedPage Today: Lyme Disease Vaccine Candidate Just Misses Its Mark In Late-Stage Trial
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)
MedPage Today: Fenebrutinib May Curb Chronic Active Lesions In Multiple Sclerosis
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)
