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UniQure

This page shows the latest UniQure news and features for those working in and with pharma, biotech and healthcare.

UniQure gets speedy US review for Huntington’s gene therapy

UniQure gets speedy US review for Huntington’s gene therapy

Pioneer gaining momentum again. UniQure has claimed a fast-track review from the FDA for a gene therapy for Huntington’s disease due to start a phase 1/2 trial later ... Matt Kapusta. “Achieving fast track designation from the FDA underscores the

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  • Bluebird: on a mission to ‘recode’ the DNA of healthcare Bluebird: on a mission to ‘recode’ the DNA of healthcare

    Gene therapy failures. The industry and Europe’s healthcare systems are wary of that magic one million threshold, thanks to the failure of the first ever gene therapy, UniQure’s Glybera. ... The success or failure of Bluebird will be closely watched

  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    success. Europe has already seen two gene therapies approved but fail commercially – UniQure’s Glybera and GSK’s Strimvelis – and so Bluebird has to learn lessons on pricing and reimbursement and ... The EMA approved the world’s first ever

  • Rare diseases: meeting the challenge Rare diseases: meeting the challenge

    Unfortunate message. Some of these thorny problems were encapsulated in uniQure’s recent decision not to seek an extension to its five-year European marketing authorisation - which expires in October - for

  • Pharma deals in April 2015 Pharma deals in April 2015

    BMS will also take a 4.9% equity stake in uniQure which will cost around $32m, with another 5% ownership scheduled before the end of the year (at 10% premium). ... UniQure also stands to receive research, development and regulatory milestones, including

  • Medius Deal Watch table for April 2015 Medius Deal Watch table for April 2015

    32, 700. uniQure NV/ Bristol-Myers Squibb. R&D collaboration plus equity investment.

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  • Solaris Health looks at the gene therapy revolution

    There has already been one notable disappointment. In 2017 uniQure pulled its gene therapy, Glybera (alipogene tiparvovec) for the rare inherited disorder lipoprotein lipase deficiency (LPLD) from Europe after 5 years,

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