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Luxturna Secures English Reimbursement In Record Time

 
• By Ian Schofield

Novartis/Spark’s Luxturna has been authorized by NICE for use in England after the company agreed a discount on the list price that made the gene therapy cost effective for the national health service. The recommendation was made in record time thanks to good collaboration between the two parties.

Eye
NICE has OKd Luxturna for a rare eye disorder

The National Institute for Health and Care Excellence (NICE) has given the green light to the use of Novartis/Spark’s Luxturna (voretigene neparpovec) on the national health service in England and Wales, following a rapid evaluation of the gene therapy that NICE and Novartis said was the result of "early and constructive" engagement.

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More from United Kingdom

Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry

 
• By Leela Barham

Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.

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Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

UK MHRA Tackles Staff Burnout As It Eliminates Filings Backlog

 
• By Vibha Sharma

Efforts by the medicines regulator, the MHRA, to clear all backlogs relating to its statutory functions and maintaining predictable review timeframes have put pressure on its staff.

More from Europe

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By Leela Barham

Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.