News & Events:BLUE

Bluebird bio Inc (BLUE): * BLUEBIRD BIO AND RESILIENCE ANNOUNCE STRATEGIC ALLIANCE TO DEVELOP NEXT GENERATION CELL THERAPIES. * BLUEBIRD BIO (BLUE) - TO RECEIVE $110 MILLION UPFRONT, PREFERRED LVV MANUFACTURING ACCESS AND SIGNIFICANTLY REDUCE OPERATIONAL EXPENSES OVER COMING YEARS.

Resilience to acquire bluebird’s clinical and commercial suspension lentiviral vector manufacturing facility in North Carolina, retaining all current employees at the site Alliance designed to foster best in class cell therapy product and manufacturing innovation through risk-sharing and royalty-based model bluebird to receive $110M upfront, preferred LVV manufacturing access and significantl...

NEW YORK---- Bristol Myers Squibb (BMY) today reports results for the second quarter of 2021, which reflect robust product sales, continued advancement of the pipeline and strong clinical and operational performance across the company.

NEW ORLEANS, La., July 23, 2021 Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC, announces that KSF has commenced an investigation into bluebird bio, Inc..  . In May 2020, the Company announced its plans to submit an application to the U.S. Food and Drug Administration for its product, LentiGlobin, in the second half of 2021.

bluebird bio Inc: * BLUEBIRD BIO RECEIVES EC APPROVAL FOR SKYSONA™ GENE THERAPY FOR PATIENTS LESS THAN 18 YEARS OF AGE WITH EARLY CEREBRAL ADRENOLEUKODYSTROPHY WITHOUT MATCHED SIBLING DONOR. * SKYSONA IS THE FIRST AND ONLY GENE THERAPY APPROVED IN THE EU TO TREAT EARLY CALD Source text for Eikon: Further company coverage:

SKYSONA is the first and only gene therapy approved in the EU to treat early CALD CALD is a rare neurodegenerative disease that can lead to progressive, irreversible loss of neurologic function, and death One-time treatment with SKYSONA has been shown to have a durable effect in improving survival outcomes and preserving neurologic function across pivotal and long-term studies, with the longes...

BLUEBIRD BIO INC (BLUE): * BLUEBIRD BIO ANNOUNCES POSITIVE RECOMMENDATION BY PRAC REGARDING ARTICLE 20 SAFETY REFERRAL REVIEW OF ZYNTEGLO™ GENE THERAPY FOR TRANSFUSION-DEPENDENT Β-THALASSEMIA AND MARKETING TO RESUME IN EU. * BLUEBIRD BIO INC (BLUE) - COMPANY HAS INFORMED EMA OF LIFT OF VOLUNTARY TEMPORARY MARKETING SUSPENSION.

EMA’s Pharmacovigilance Risk Assessment Committee confirms favorable benefit-risk balance of ZYNTEGLO Company has informed EMA of lift of voluntary temporary marketing suspension bluebird bio, Inc. today announced that the European Medicines Agency's Pharmacovigilance Risk Assessment Committee has concluded based on the review of all available data that the benefit-risk balance of medicinal p...

* EMA: EMA FINDS NO EVIDENCE LINKING VIRAL VECTOR IN ZYNTEGLO TO BLOOD CANCER: Further company coverage:

Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC, announces that KSF has commenced an investigation into bluebird bio, Inc.. In May 2020, the Company announced its plans to submit an application to the U.S. Food and Drug Administration for its product, LentiGlobin, in the second half of 2021.

With 51 patients enrolled, data from the long-term follow-up study show that all patients treated with beti-cel who achieve transfusion independence remain free from transfusions, with the longest follow-up of seven years Across Phase 3 studies, 89% of evaluable patients across ages and genotypes achieved TI and remain transfusion free, including 91% of evaluable pediatric patients under the a...

bluebird bio, Inc. today announced that members of the management team will participate in the Goldman Sachs 42nd Annual Global Healthcare Conference, Tuesday, June 8, at 8:50 a.m. ET.

BLUEBIRD BIO INC (BLUE): * BLUEBIRD BIO ANNOUNCES LIFTING OF FDA CLINICAL HOLD FOR SICKLE CELL DISEASE AND Β-THALASSEMIA STUDIES. * BLUEBIRD BIO INC (BLUE) - IS WORKING CLOSELY WITH STUDY INVESTIGATORS AND CLINICAL TRIAL SITES TO RESUME ALL STUDY ACTIVITIES AS SOON AS POSSIBLE Source text for Eikon: Further company coverage:

bluebird bio, Inc. today announced that the U.S. Food and Drug Administration has lifted the clinical holds on the Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin for sickle cell disease gene therapy for adult and pediatric patients with SCD, and the Phase 3 Northstar-2 and Northstar-3 studies of betibeglogene autotemcel gene therapy for adult, adolescent and pediatric patients wit...

bluebird bio, Inc. today announced that the Compensation Committee of the Company’s Board of Directors approved inducement grants of stock options to purchase a total of 50,000 shares of common stock and 25,000 restricted stock units to its Chief Commercial Officer Tom Klima with a grant date of June 1, 2021.

BLUEBIRD BIO INC (BLUE): * BLUEBIRD BIO RECEIVES POSITIVE CHMP OPINION FOR SKYSONA GENE THERAPY FOR PATIENTS LESS THAN 18 YEARS OF AGE WITH EARLY CEREBRAL ADRENOLEUKODYSTROPHY. * BLUEBIRD BIO INC (BLUE) - AS OF DATA CUTOFF DATE, 90% PATIENTS TREATED WITH SKYSONA IN PIVOTAL ALD-102 CLINICAL STUDY MET PRIMARY ENDPOINT Source text for Eikon: Further company coverage:

SKYSONA is the first and only gene therapy recommended for approval for patients with CALD, a progressive, neurodegenerative disease As of the data cutoff date, 90% of patients treated with SKYSONA in the pivotal ALD-102 clinical study met the primary endpoint of major functional disability-free survival at two years of follow-up Data from the long-term follow-up study suggest that SKYSONA co...

BRISTOL MYERS: * DATA FROM PIVOTAL KARMMA STUDY SHOW 24.8-MONTH MEDIAN OVERALL SURVIVAL IN TRIPLE-CLASS EXPOSED MULTIPLE MYELOMA. * CYTOPENIAS, CYTOKINE RELEASE SYNDROME WERE MOST COMMON ADVERSE EVENTS OF ANY GRADE IN KARMMA STUDY. * INVESTIGATOR-REPORTED NEUROTOXICITY OF ANY GRADE WAS REPORTED IN 18% OF PATIENTS IN KARMMA STUDY.

Data from pivotal KarMMa study to be presented at ASCO21 show 24.8-month median overall survival in triple-class exposed multiple myeloma With more than 24-month median follow-up, results represent longest follow-up to date from a global clinical trial of a CAR T cell therapy in multiple myeloma with 73% overall response rate and responses ongoing Analysis of characteristics of neurotoxicity ob...

AavantiBio, a gene therapy company focused on transforming the lives of patients with rare genetic diseases, today announced the appointment of Jessie Hanrahan, Ph.D. as Chief Regulatory Officer. Dr. Hanrahan brings to AavantiBio nearly 15 years of experience in the biotech industry and a strong track record of achievements and leadership in global regulatory affairs and drug development.