US FDA Quashes Citizen Petition Against Bluebird’s Zynteglo That Cited Patent, Safety Concerns
San Rocco, whose potential rival gene therapy for thalassemia is in preclinical development, had wanted FDA to delay approval of bluebird’s BLA until resolution of a patent case and a ‘careful investigation’ of Zynteglo’s risks.
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Keeping Track: Axsome’s Auvelity Survives Long Review; Bluebird’s Zynteglo Cleared For Liftoff; Omeros Appeals CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Bluebird bio’s Tom Klima told Scrip launch preparations are well under way, including negotiations with payers on outcomes-based reimbursement agreements.
Gene Therapy: Bluebird’s Beti-Cel Sails Through US Panel Review On Strength of ‘Impressive’ Efficacy
Treatment is a potential game-changer for patients with transfusion-dependent beta-thalassemia, committee members said; panel was hesitant to extrapolate the hematological malignancies seen with bluebird’s other lentiviral vector programs to beti-cel.