bluebird bio
NEWS
The European Medicines Agency has launched a safety review of bluebird bio’s thalassaemia drug Zynteglo, a conditionally licensed gene therapy in Europe.
Preliminary findings of LentiGlobin suggested that the BB305 LVV vector was present in the AML blast cells, but there was not sufficient information to determine causality.
Bristol Myers Squibb and bluebird bio said data from the Phase II KarMMa study evaluating the safety and efficacy of ide-cel (idecabtagene vicleucel) met the primary endpoint of overall survival and the key secondary endpoint of complete response rate.
The hold comes just after patient dosing began in HGB-210, the company’s Phase III single-arm open-label LentiGlobin trial for SCD patients between the ages of 2 and 50.
Bluebird bio announced that it has placed its Phase I/II and Phase III trial of LentiGlobin gene therapy for sickle cell disease (SCD) on temporary suspension.
Bluebird bio announced plans to split its genetic disease and oncology businesses. Bluebird bio will stay focused on severe genetic disease and spin out its oncology business into a new company.
The American Society of Hematology (ASH) Annual Meeting & Exposition began December 5, and there were numerous presentations, abstracts and posters. Here’s a look at some of the stories out of the first day.
The company announced late Wednesday that its sickle cell disease gene therapy treatment will not be submitted to the U.S. Food and Drug Administration for two more years.
Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review.
JOBS
IN THE PRESS
bluebird bio, Inc. (Nasdaq: BLUE) announced today that the company has placed its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease (SCD) (bb1111) on a temporary suspension due to a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML).
bluebird bio, Inc. announced its intent to separate its severe genetic disease and oncology businesses into differentiated and independent publicly traded companies.
No severe vaso-occlusive events (VOEs) reported through 24 months of follow-up in Group C patients who had a history of at least four severe VOEs and at least six months of follow-up (n=19)
Longer-term data from Phase 1 CRB-401 study evaluating ide-cel in relapsed and refractory multiple myeloma show ongoing deep and durable responses and median overall survival of 34.2 months
bluebird bio, Inc. announced that the company will host a live webcast on December 7, 2020 at 7:00 p.m. ET to review clinical data presented at the 62nd American Society of Hematology Annual Meeting and Exposition.
bluebird bio, Inc. (NASDAQ: BLUE) today announced that members of the management team will participate in the following upcoming investor conferences: Cowen 2020 IO Next Summit, Friday, November 13, at 11:15 am ET Barclays Gene Editing & Gene Therapy Summit, Monday, November 16, at 7:45 am ET To access the live webcasts of bluebird bio’s presentations, please visit the “Events & Presentati
bluebird bio, Inc. (NASDAQ: BLUE) today reported financial results and business highlights for the third quarter ended September 30, 2020 and shared recent operational progress. “While 2020 continues to present unprecedented challenges, bluebird has continued to advance our innovative cell and gene therapy programs. Looking to 2021 and b
bluebird bio, Inc. announced that the European Medicines Agency accepted the company’s marketing authorization application for its investigational elivaldogene autotemcel gene therapy for the treatment of patients with cerebral adrenoleukodystrophy.
bluebird bio, Inc. (NASDAQ: BLUE) today announced that members of the management team will participate in the Jefferies Cell Therapy Virtual Summit, Tuesday, October 6, at 2:00 p.m. ET. To access the live webcast of bluebird bio’s presentation, please visit the “Events & Presentations” page within the Investors & Media section of the bluebird bio website at http://investor.bluebirdbio.com . Replays of the
EMA’s PRIME program designed to optimize development and expedite evaluation of innovative medicines for patients with high unmet need