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UK Court Ruling Ends Novartis/Bayer Crusade Against Avastin In AMD

Off-Label Use Does Not Undermine Licensing System

 
• By Ian Schofield

AMD patients in the UK can legitimately be given compounded bevacizumab (Roche’s Avastin) after the appeals court said NHS trusts could offer a drug off-label for economic reasons where there were no safety or efficacy concerns. 

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Avastin can be given off-label for AMD by injection into the eye • Source: Shutterstock

The Court of Appeal for England and Wales has ruled that clinical commissioning groups (CCGs) can offer Roche’s Avastin (bevacizumab) to patients with wet age-related macular degeneration, even though it is not licensed for that indication.

In doing so the court has finally put an end to a long-running effort by Novartis and Bayer to prevent Avastin, which is approved as an anticancer drug, from being used on the National Health Service in place of their much more expensive

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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.

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.

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.

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