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House E&C Committee Passes Biosimilar Competition Act (34-17)

House Energy & Commerce Committee advanced the Biosimilar Competition Act with bipartisan support. Key provisions include streamlined FDA biosimilar review, patent dance reform, and 180-day first interchangeable biosimilar exclusivity. Bill moves to House floor.

CMS Publishes Round 3 IRA Drug Negotiation List — 20 Additional Drugs

CMS published the final Round 3 list of 20 additional drugs for Medicare price negotiation under the IRA. 12 National Biopharma Coalition members have products on the expanded list with combined revenue exposure of $5.2B. First-time inclusion of oncology biologics and gene therapies signals broadening scope.

FDA Issues Landmark AI/ML Medical Device Draft Guidance

FDA released comprehensive draft guidance for AI/ML-based software as medical devices. Framework establishes predetermined change control plans allowing continuous algorithm learning, risk-based regulatory tiers, and real-world performance monitoring requirements.

Senate Finance Markup Amends Hospital Outpatient Payment Rule

Senate Finance Committee markup introduced amendments to CMS OPPS proposed rule, expanding site-neutral payment to 12 additional service categories while adding a 3-year transition period for affected hospitals. Amendment also increases quality reporting measures.

Senate Finance Holds Hearing on Prescription Drug Affordability Act

Senate Finance Committee held a hearing on S-2847 with testimony from patient advocates, pharma industry representatives, and state affordability board members. Committee Chairman signaled intent to mark up bill within 60 days.