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Spark Therapeutics files marketing authorization application at EMA for the treatment of Leber’s congenital amaurosis (LCA)

Spark Therapeutics (NASDAQ:ONCE), a gene therapy company based in Philadelphia, USA, has announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for Investigational “LUXTURNA” (voretigene neparvovec). The gene therapy treatment, designed for patients with vision loss due to Leber’s congenital amurosis, has similarly undergone regulatory submission in the United States. […]

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Ophthalmic biopharmaceutical company raises $7.5M for the development of new treatments for sight-threatening disorders

Ocugen Inc., an ophthalmic biopharmaceutical company based in Pennsylvania, USA, has announced the close of a $7.5M venture capital funding to support the development of new therapeutics for a range of sight-threatening diseases. The company has a series of novel treatment approaches for ophthalmic disorders which include ocular graft versus host disease, retinitis pigmentosa, geographic […]

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Uncertainty for gene therapy following withdrawal from market of Europe’s first gene therapeutic

Dutch biotechnology company uniQure B.V., (NASDAQ:QURE), Amsterdam, The Netherlands, has announced that it will not pursue the renewal of its Glybera (alipogene tiparvovec) marketing authorization in Europe, scheduled to expire on October 25, 2017. The withdrawal by uniQure has nothing to do with safety issues according to the company, instead matters of pricing, re-imbursement and […]

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