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Cost Of Providing CAR-T Therapies Could Derail Reimbursement In England

 
• By Francesca Bruce

Gilead claims that the mechanism used to work out the cost for the National Health Service in England of delivering CAR-T therapies to patients could threaten access to these medicines.

Derailed train
Access to CAR T therapies risks being derailed • Source: Shutterstock

Gilead Sciences, Inc. is calling for more transparency on how the National Health Service (NHS) in England arrived at figures on the cost of delivering CAR-T therapies to patients. The company's Gordon Lundie has warned that if the health technology appraisal body NICE continues to accept these costs, it will be impossible for companies selling CAR-T therapies to offer a price that NICE regards as cost effective.

In July, NICE issued draft guidance rejecting Kite’s CAR-T therapy Yescarta (axicabtagene ciloleucel) for treating adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines...

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

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New EU Approvals

 
• By Neena Brizmohun

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More from Geography

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

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