Navigating Unapproved Therapies, AI in Healthcare, and Pharma Legal Battles: Key Industry Shifts

In this episode, we explore key developments in the healthcare landscape. First, we discuss the guidelines from rarediseases.org on accessing unapproved therapies, emphasizing the balance between patient needs and safety. Next, we examine the impact of CMS's decision to terminate a primary care program on rural clinics, alongside discussions at ViVE 2026 on AI in healthcare. We also cover a private equity firm's acquisition of Enhabit and Abbott's bond sale for acquiring Exact Sciences. The New England Journal of Medicine highlights the potential of ancient immune defenses in modern genetic therapies. Meanwhile, the FDA reviews Regeneron's garetosmab for a rare bone disease, FOP. We also touch on the promise of novel therapies for rare diseases and Bayer's legal action against Johnson & Johnson over prostate cancer treatment claims.

https://www.lucidhealthsolutions.com

https://www.lucidhealthsolutions.com

📚 Sources:

• https://rarediseases.org/wp-content/uploads/2017/05/CommunityExpandedAccessPrinciples_May2Final.pdf
• https://www.modernhealthcare.com/providers/mh-cms-making-care-primary-lead-model/
• https://www.nejm.org/doi/abs/10.1056/NEJMe078017
• https://pharmaphorum.com/news/fda-starts-review-regenerons-drug-rare-disease-fop
• https://everylifefoundation.org/wp-content/uploads/2017/09/Chris-Austin-NIH.pdf
• https://www.statnews.com/2026/02/20/cancer-immunotherapy-morning-infusions-doubts-about-study/

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