Bluebird Bio's Zynteglo Flies Through Its CHMP Review
A nod in record time from the European Medicines Agency’s CHMP for its beta-thalassemia gene therapy Zynteglo pushes bluebird bio out of the nest and into commercial territory.
You may also be interested in...
CEO Nick Leschly talked to Scrip about the European payment strategy for the one-time gene therapy, which will cost €1.575m over five years if treatment is successful.
US financial regulators have not been quick at reviewing Roche’s multi-billion dollar acquisition of gene therapy biotech Spark Therapeutics, but it is still on track for completion in the first half of 2019.
bluebird bio is set to enter the EU market with the first gene therapy for transfusion-dependent β-thalassemia, after the European Medicines Agency reviewed its product in record time. Bluebird believes that the agency’s Priority Medicines (PRIME) and adaptive pathways programs have been instrumental in smoothing its path.