bluebird bio
NEWS
CRISPR Therapeutics could be on the cusp of achieving a first in gene therapy, the first company to achieve regulatory approval for a CRISPR-Cas9 program.
Third Rock Ventures Fund VI, providing the company with $1.1 billion to invest in new life science companies. This brings Third Rock to a total of $3.8 billion across its venture funds.
The annual BIO convention has returned, bringing thousands of life sciences companies worldwide to the annual networking event that could spark collaborations and deals.
Shares of CRISPR Therapeutics fell more than 11% on Monday as investors react negatively to the endorsement of a rival beta-thalassemia gene therapy developed by bluebird bio.
For the second straight day, the FDA’s Cell, Tissue and Gene Therapies Advisory Committee voted unanimously to approve a bluebird lentiviral vector (LVV) gene therapy.
Following a marathon session of the FDA’s Cell, Tissue and Gene Therapies Advisory Committee, bluebird bio passed its first critical hurdle in approval for the lentiviral vector gene therapy, eli-cel.
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.
JOBS
IN THE PRESS
bluebird bio, Inc. (NASDAQ: BLUE) today announced that members of the management team will participate in the following upcoming investor conferences.
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).