uniQure

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NICE unconvinced by CSL's haemophilia B gene therapy

The UK's National Institute for Health and Care Excellence (NICE) has said it is minded not to recommend approval of CSL Behring and uniQure's Hemgenix gene therapy for ha

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uniQure craters on Huntington’s gene therapy data

uniQure has presented new results from its phase 1/2 study of its gene therapy for Huntington’s disease that

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CSL’s Hemgenix is first haemophilia B gene therapy in EU

Firm will work with payers to try to secure access for as many patients across EU as possible.

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CSL closes on EU approval for haemophilia B gene therapy

CSL's gene therapy for haemophilia B has been recommended for approval by the EMA's human medicine committee, setting up a decision by the European Commission early next year.

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uniQure, CSL claim first okay for haemophilia B gene therapy

uniQure and CSL have become the first pharma companies to get regulatory approval for a gene therapy for haemophilia B anywhere in the world, after the FDA cleared their Hemgenix therapy fo

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Trial sets up filings for uniQure's haemophilia gene therapy

Dutch biotech uniQure and partner CSL Behring are planning to file for approval of their gene therapy for haemophilia B, armed with new trial data that they say answers earlier concerns abo

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