FDA Probes Potential Life-Threatening Blood Cancer Risks Linked …
2 days ago · On Wednesday, the FDA raised concerns about life-threatening hematologic malignancies in patients treated with Bluebird Bio Inc’s (NASDAQ:BLUE) Skysona (elivaldogene autotemcel), a gene therapy ...
FDA Probes Potential Life-Threatening Blood Cancer Risks
3 days ago · The FDA is investigating reports of life-threatening blood cancers linked to Skysona, a gene therapy for CALD. Providers are urged to consider safer alternatives and monitor patients for malignancies.
FDA probes blood cancer risk from bluebird's gene therapy, …
Bluebird's Skysona was approved by the FDA in 2022 for the treatment of cerebral adrenoleukodystrophy (CALD) and was priced at $3 million at the time of its launch. CALD, which affects about 1 in ...
FDA investigating safety risks of bluebird's Skysona
4 days ago · The FDA said it is evaluating the need for additional regulatory action regarding the safety of bluebird bio’s (NASDAQ:BLUE) gene therapy Skysona, which is used to treat children with cerebral ...
Bluebird bio lays off 25% of workforce as gene therapy pioneer ...
Sep 24, 2024 · After bluebird bio acknowledged troubles keeping its business operational, the gene therapy biotech is launching a restructuring that will reduce the size of its workforce by about 25%.
New data underline cancer risk of Bluebird therapy for brain disease
Oct 10, 2024 · Seven young boys with a rare brain disorder developed myelodysplastic syndromes or acute myeloid leukemia after receiving Skysona, a personalized gene therapy from Bluebird bio. The FDA approved Skysona in 2022 despite the cancer risk, but new data show its benefit and safety are still uncertain.
After missing out on FDA voucher, bluebird quickly raises funds to ...
Dec 19, 2023 · Now, bluebird is hurrying to raise millions of dollars—through two separate avenues—to fund the launch of its new sickle cell disease gene therapy and others. In one fundraising approach,...
bluebird bio Announces First Outcomes-Based Agreement with …
Mar 11, 2024 · bluebird bio, a biotech company, announced its first outcomes-based contract with Michigan Medicaid for LYFGENIA, a one-time gene therapy for sickle cell disease. The agreement is designed to...
bluebird bio Reports First Quarter 2024 Results and Highlights ...
May 9, 2024 · - First patient start (cell collection) for LYFGENIA completed – - 15 patient starts to date in 2024 (11 ZYNTEGLO, 3 SKYSONA, 1 LYFGENIA); 85 to 105 patient starts anticipated across the portfolio in 2024 - - First quarter 2024 net revenue of $18.6 million- - Management to host conference call today, May 9, 2024 at 8:00 am ET- SOMERVILLE, Mass.--(BUSINESS WIRE)--May 9, 2024-- bluebird bio ...
First Patient Begins Newly Approved Sickle Cell Gene Therapy
May 6, 2024 · Kendric Cromer, 12, the first commercial patient for Bluebird Bio’s gene therapy to cure his sickle cell disease, in the hospital as his bone marrow stem cells were being removed for gene editing.