bluebird bio
NEWS
Bluebird bio faces a two-day crucible as the U.S. Food and Drug Administration’s Cell, Tissue and Gene Therapies Advisory Committee will give two lentiviral vector gene therapies a thumbs up or down.
For the first time in half a decade, the FDA will convene to address two therapies developed by bluebird bio that could have ripple effects across the industry regarding lentiviral vectors.
As May gets off to a slow start for the FDA calendar, a few companies have important target action dates.
Drug pricing watchdog ICER issued a draft report on bluebird bio’s gene therapy betibeglogene autotemcel for beta-thalassemia. The report touted the therapy’s cost-effectiveness.
Following the ongoing trend in the pharmaceutical industry, approximately 30% of bluebird’s staff will be let go in an effort to reduce operational costs to under $340 million by the end of 2022.
Shares of bluebird bio were falling rapidly in premarket trading Monday morning after the company revealed its dire financial straits over the weekend.
Recent gene therapy research has created a durable response in terms of producing normally-shaped red blood cells and reducing the pain of sickle cell disease.
After guiding the commercial rollout of embattled Alzheimer’s drug Aduhelm for Biogen, Johanna Rossell has departed the company for a leadership role at Enzyvant.
The extensions are due to the FDA’s requiring more time to review additional clinical data it had requested from bluebird.
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IN THE PRESS
bluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has approved ZYNTEGLO® (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.
bluebird bio, Inc. reported financial results and business highlights for the second quarter ended June 30, 2022, and shared recent operational progress.
bluebird bio, Inc. (Nasdaq: BLUE) today announced the outcome of the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) discussion of betibeglogene autotemcel (beti-cel) for the treatment of people with beta-thalassemia who require regular red blood cell (RBC) transfusions.
bluebird bio, Inc. announced the outcome of the U.S. Food and Drug Administration’s Cellular, Tissue, and Gene Therapies Advisory Committee discussion of elivaldogene autotemcel for the treatment of early active cerebral adrenoleukodystrophy in patients less than 18 years of age who do not have an available and willing human leukocyte antigen -matched sibling hematopoietic stem cell donor.
bluebird bio stock trading halted today June 9th and tomorrow June 10th.
June 9 discussion will focus on eli-cel for the treatment of early active cerebral adrenoleukodystrophy in patients without a matched sibling donor and overall safety of lentiviral vector (LVV) gene therapy.
Following a review of its strategic priorities, bluebird bio, Inc. (Nasdaq: BLUE) today announced that the Company is initiating a comprehensive restructuring intended to deliver up to $160 million in cost savings over the next two years.
bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the fourth quarter and full year ended December 31, 2021, shared recent operational progress, and provided a corporate update.
bluebird Provides Update on FDA Review Timelines for Betibeglogene Autotemcel (beti-cel) for Beta-Thalassemia and Elivaldogene Autotemcel (eli-cel) for Cerebral Adrenoleukodystrophy (CALD).
bluebird bio to Provide Update on Program Milestones and 2022 Financial Outlook at the 40th Annual J.P. Morgan Healthcare Conference.