(+) Will the floodgates open for gene therapy? (Nat Biotechnol) - Sep 10, 2012 - Towards the end of Jul, 2012 the EMA's CHMP recommended the approval in the EU of a treatment called Glybera (alipogene tiparvovec) from the uniQure Biopharma; Unless matters get untypically administratively complicated, it should be only a matter of days before the EC endorses this recommendation, making the approval official
Anticipated EU regulatory • Dyslipidemia
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In a matter of days, a momentous event will occur: a gene therapy will, for the first time anywhere in the Western hemisphere, be available commercially with full marketing approval.
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Towards the end of July, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the approval in the European Union of a treatment called Glybera (alipogene tiparvovec) from a small Dutch company, uniQure biopharma. Unless matters get untypically administratively complicated, it should be only a matter of days before the European Commission endorses this recommendation, making the approval official.
(IR7)
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