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Roche, Novartis Lose French Court Battle Over Off-Label Use Of Avastin In AMD

Executive Summary

Roche and Novartis have been unsuccessful in their attempt to stop the French authorities using Avastin off label in wet AMD for financial reasons.

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

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English Court Queries EMA Primacy & Says Avastin Can Be Used In AMD

The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.

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