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Luxturna

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

FDA expecting boom in cell and gene therapies

FDA expecting boom in cell and gene therapies

The last couple of years have already seen the approval of the first gene therapy in the US – Spark Therapeutics’ Luxturna for a rare disease – as well as new cell therapies

Latest news

  • EMA sees approval numbers rise in 2018 EMA sees approval numbers rise in 2018

    From these, 21 were orphan medicines (exactly 50%) and three were advanced therapy medicinal products – Novartis’ Kymriah and Gilead/Kite’s Yescarta CAR-T therapies, plus Spark’s Luxturna, co-marketed

  • Novartis gets EU nod for Luxturna gene therapy Novartis gets EU nod for Luxturna gene therapy

    Novartis has secured EMA approval Luxturna, a gene therapy for a rare eye disease, almost a year after it was given the green light in the US. ... for Clinical and Economic Review (ICER) has suggested the price of Luxturna should come down 75% from list

  • Encouraging data for GenSight’s blinding retinal disease gene therapy Encouraging data for GenSight’s blinding retinal disease gene therapy

    Just last month, the EMA’s advisory committee gave the all clear to Spark’s Luxturna to treat adults and children suffering from inherited retinal dystrophy. ... Luxturna, was the first ever gene therapy to be approved for any form of genetic

  • New chair for Europe’s key medicines committee New chair for Europe’s key medicines committee

    The CHMP has just recommended Luxturna, Spark's gene therapy, the product having first been reviewed by the EMA's new expert committee on Advanced Therapy Medicinal Products (ATMPs), the Committee

  • CHMP backs Spark’s Luxturna, but rejects Sarepta again CHMP backs Spark’s Luxturna, but rejects Sarepta again

    Contrasting fortunes for rare disease treatments. Spark Therapeutics looks set for approval of its eye disorder gene therapy Luxturna on both sides of the Atlantic after getting a green light from ... The EMA’s advisory committee recommended approval

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Latest Intelligence

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

    drugs, Novartis’ Kymriah and Gilead/Kite’s Yescarta and Spark Therapeutics’ gene therapy Luxturna all reaching the market last year. ... Spark's Luxturna: already approved in the US, expected to gain EU approval by late 2018.

  • Health on instalment Health on instalment

    For example, the ophthalmic drug Luxturna, approved last year, costs $850, 000 per dose. ... For example, Luxturna maker Spark Therapeutics approached a commercial payer with a pay-for-performance option.

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