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Medicare Final CAR-T Policy Eases Coverage Requirements

 
• By Cathy Kelly

Product developers and researchers applaud the changes, including dropping "coverage with evidence development" approach.

T cells
CAR-T Treatment Access No Longer Theatened By Policy

In its long-awaited final national coverage determination on chimeric antigen receptor T-cell (CAR-T) therapies, the US Centers for Medicare and Medicaid Services dropped the condition it had proposed earlier that Medicare will cover treatment only if patient data is collected following administration through registries or clinical trials.

CMS also backed off previous specifications on what indications would be covered and that treatment must be administered in the...

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Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

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‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

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