How to deal with gene therapy’s evidence problem

Little long-term data exists on gene therapy's effectiveness and downstream risks, including unforeseen malignancies. New evidence pathways could support coverage. 

April 23, 2024 Check out STAT+

Sponsored By

Adobe STAT+ | Opinion: Use evidence to support early coverage of gene therapy after accelerated approval With little known about the long-term risks of gene therapy, payers are reluctant to cover it. Collecting novel evidence can help. By Lee A. Fleisher and Matthew A. Fleisher STAT+ | Opinion: How AI can help satisfy FDA's drug, device diversity requirements AI and machine learning can help life sciences companies increase diversity in clinical trials for drug and device development. By Wendy Cheng Opinion: An FDA pathway can accelerate innovation for Duchenne muscular dystrophy Few treatments are available for people with Duchenne muscular dystrophy. The FDA's accelerated approval program can help change that. By Jennifer Handt

More around STAT

Check out more exclusive coverage with a STAT+ subscription Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

---

Enjoying Cancer Briefing? Tell us about your experience Continue reading the latest health & science news with the STAT app Download on the App Store or get it on Google Play

STAT, 1 Exchange Place, Boston, MA ©2024, All Rights Reserved. I no longer wish to receive STAT emails

Update Newsletter Preferences     •    Contact Us     •    Advertise with Us     •    View in Browser