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tag luxturna

bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

SEPTEMBER 30, 2022

Spark Therapeutics’ Luxturna, indicated for inherited retinal disease (IRD), was the first gene therapy to be approved, in 2017, with a price tag of $850,000 for each eye. Prior to bluebird's approvals, there were only two FDA-approved gene therapies for inherited conditions on the market.

Gene Therapy

Gene Therapy FDA Approval Gene Genetic Disease

Zynteglo halt re-ignites viral vector safety concerns; analysts

pharmaphorum

FEBRUARY 22, 2021

That therapy uses an adeno-associated virus (AAV) as a vector rather than a lentivirus, a vector type that features in approved gene therapies such as Roche’s Luxturna and Novartis’ Zolgensma. The case comes just weeks after UniQure halted a trial of its haemophilia B gene therapy AMT-061 after an unexpected case of liver cancer.

Gene Therapy

Gene Therapy Gene Gene Sequencing Gene Expression

bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Zynteglo halt re-ignites viral vector safety concerns; analysts

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