bluebird bio
NEWS
Bayer has high hopes of driving its prostate cancer drug into blockbuster status, meaning over $1 billion in annual sales. This week’s ARASENS trial results should help pave the road.
The FDA has granted Cambridge-based bluebird Bio a Priority Review of its Biologics License Application for betibeglogene autotemcel (beti-cel).
Two weeks after Novartis announced it would sell its nearly one-third voting stake in next-door neighbor Roche, investors are chomping at the bit to find out how that almost $21 billion will be put to work.
bluebird bio has completed the spin-off of its oncology programs into the new business entity, 2seventy bio, Inc, which will begin trading on the Nasdaq this morning under the ticker symbol “TSVT.”
Novartis is reviewing its Sandoz division to determine the best moves to maximize value for shareholders. The strategic review will explore all options for the Swiss pharma giant.
The battle between bluebird bio and Errant Gene Therapeutics has escalated into a patent lawsuit. Errant alleges that bluebird’s gene therapies infringe on their patents for recombinant vectors.
Biopharma companies recognized that developing a therapy is merely the beginning of what is needed to connect patients with sickle cell disease to next-level therapies.
There was plenty of clinical trial updates last week. Here’s a look.
The hold is related to a report of a SUSAR of myelodysplastic syndrome in a patient treated with eli-cel, also known as Lenti-D, in a Phase III clinical trial.
JOBS
IN THE PRESS
bluebird bio, Inc . (Nasdaq: BLUE) today announced it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration
bluebird bio, Inc. (NASDAQ: BLUE) announced today that it has entered into an agreement for a $75 million private placement of common stock and common stock equivalents with a healthcare investment fund selected as part of a competitive process.
bluebird bio, Inc. announced key management and board appointments in advance of the company’s planned separation, targeted for mid-October, 2021.
On track to complete planned business separation in 4Q 2021; each company launching with approximately 24 months of runway following separation –
bluebird bio, Inc. announced that the Company will report financial results for the second quarter ended June 30, 2021 on Monday, August 9, 2021 and host a conference call to discuss the quarterly update on Monday, August 9, 2021 at 8 a.m. ET.
bluebird bio, Inc. announced that the Compensation Committee of the Company’s Board of Directors approved inducement grants of stock options to purchase a total of 85,000 shares of common stock and 50,000 restricted stock units to a newly hired employee with a grant date of August 2, 2021.
bluebird bio, Inc. announced that the European Commission has granted marketing authorization of SKYSONA™, a one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age with an ABCD1 genetic mutation, and for whom a human leukocyte antigen -matched sibling hematopoietic stem cell donor is not available.
bluebird bio, Inc . (Nasdaq: BLUE) today announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded based on the review of all available data that the benefit-risk balance of medicinal products containing ZYNTEGLO™ (betibeglogene autotemcel gene therapy) remains favorable.
bluebird bio, Inc. presented data from several studies of betibeglogene autotemcel gene therapy in adult, adolescent and pediatric patients with transfusion-dependent β-thalassemia.
bluebird bio, Inc . (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical holds on the Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy (bb1111) for adult and pediatric patients with SCD, and the Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies of betibeglogene autotemcel gene therapy