Bluebird Bio and Xcellbio have entered into an agreement to support the commercialization of Lyfgenia (lovotibeglogene autotemcel), Bluebird’s gene therapy for sickle cell disease, incorporating Xcellbio technology into Bluebird’s potency assay with the aim of helping to ensure the therapy’s effectiveness. “We’re humbled to play a small part in…

Bluebird Bio has announced it’s completed collecting cells from the first sickle cell disease (SCD) patient receiving the gene therapy Lyfgenia (lovotibeglogene autotemcel), following its recent approval in the U.S. The cells were collected at Children’s National Hospital in Washington D.C., which is part of the company’s…

A month after its U.S. approval, Lyfgenia (lovotibeglogene autotemcel), Bluebird Bio’s gene therapy for sickle cell disease (SCD), is readying to treat patients there. According to the company, 35 out of 48 qualified treatment centers across the U.S. started accepting patient referrals as of Jan. 5. Treatment…

On Dec. 8, the U.S. Food and Drug Administration (FDA) approved two cell-based gene therapies for sickle cell disease (SCD), a groundbreaking decision that now offers patients more than one potentially curative option that targets the underlying cause of the disease. Bluebird Bio’s Lyfgenia (lovotibeglogene autotemcel) — formerly…

If the U.S. Food and Drug Administration (FDA) approves the experimental sickle cell disease (SCD) gene therapy lovotibeglogene autotemcel (lovo-cel), its developer Bluebird Bio plans to sell the voucher it will receive that can be redeemed to speed up the review of a future application of a different…

Bluebird Bio is seeking approval from the U.S. Food and Drug Administration (FDA) for its gene therapy candidate lovotibeglogene autotemcel — lovo-cel for short — for adults and children, ages 12 and older, with sickle cell disease (SCD). The company has filed a biologics license application (BLA) to…

Bluebird Bio has provided the U.S. Food and Drug Administration (FDA) with information regarding the commercial manufacturing of its experimental gene therapy for sickle cell disease (SCD) in preparation for requesting its approval. The company had expected to submit a biologics license application seeking the approval of…

A clinical program for lovotibeglogene autotemcel (lovo-cel), an investigational gene therapy for sickle cell disease (SCD), has been suspended for patients under 18 by the U.S. Food and Drug Administration (FDA). Bluebird Bio announced the partial suspension of its program due to an ongoing investigation into persistent, nontransfusion-dependent…

Bluebird Bio is set to resume trials of LentiGlobin, its investigational gene therapy for sickle cell disease, after the U.S. Food and Drug Administration (FDA) lifted its clinical hold. The company is now working closely with study investigators and clinical trial sites to resume normal activities as soon…

Note: This story was updated June 16, 2021, to clarify that the HGB-207 and HGB-212 clinical trials were testing betibeglogene autotemcel, a gene therapy that uses the same viral vector as LentiGlobin.  A patient diagnosed initially with the blood cancer myelodysplastic syndrome (MDS) after receiving LentiGlobin, Bluebird Bio’s investigational…