US FDA Cell Tissue & Gene Therapy Advisory Committee
Eli Lilly and Creyon Bio enter oligonucleotide therapy partnership worth over $1bn
The companies will aim to develop RNA-targeted drugs for a broad range of diseases
FDA approves two cell-based gene therapies for sickle cell disease
Vertex/CRISPR and bluebird bio’s gene therapies have been approved to treat patients aged 12 years and older
bluebird bio presents positive results for inherited blood disorder gene therapies
The company’s sickle cell disease therapy was accepted for FDA priority review earlier this year
bluebird bio to sell FDA priority review voucher for $103m
The company previously sold its second voucher to Bristol Myers Squibb for $95m
bluebird bio’s sickle cell gene therapy accepted for FDA priority review
The genetic disease affects approximately 100,000 people in the US
bluebird bio submits US application for sickle cell gene therapy
The genetic disease affects approximately 100,000 people in the US alone
Sartorius signs agreement to acquire Polyplus for €2.4bn
The deal is expected to close during the third quarter of this year
bluebird bio sells second FDA priority review voucher for $95m
The company sold its first voucher to Dutch biotech Argenx for $102m
FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies
The company can now resume the enrolment and treatment of patients aged two to 17 years
bluebird bio sells Rare Pediatric Disease Priority Review Voucher
The company was granted two PRVs upon the FDA approvals of Zynteglo and Skysona
bluebird bio’s Skysona approved by FDA to treat cerebral adrenoleukodystrophy
The gene therapy was shown to slow the progression of neurologic dysfunction
bluebird bio’s beta-thalassaemia gene therapy receives FDA approval
Patients with the most severe form of the blood disorder develop life-threatening anaemia and have to receive regular blood transfusions