bluebird bio

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FDA
The FDA-approved ide-cel, which will be marketed under the brand name Abecma is going to be the second therapy for myeloma. Here’s everything you need to know.
It was a relatively quiet week in terms of clinical trial news, but there were some significant releases. Here’s a look.
Although the beginning of March was fairly slow, the end of the month shows a busy schedule for PDUFA dates for the U.S. FDA. Read on to see what’s on the calendar for this week.
Another bluebird bio executive is jumping ship. Chief Medical Officer David Davidson is leaving the company on April 16.
It was another busy week for clinical trial announcements. Here’s a look including trials for COVID-19, migraine, Parkinson’s disease, Alzheimer’s, HIV and more.
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.
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IN THE PRESS
bluebird bio, Inc. reported financial results and business highlights for the fourth quarter and full year ended December 31, 2020 and shared recent operational progress.
bluebird bio, Inc. announced that members of the management team will participate in the 10th Annual SVB Leerink Global Healthcare Conference, Thursday, February 25, at 12:00 p.m. ET.
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.