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bluebird bio re-evaluates gene therapy strategy in ‘untenable’ European market pharmatimes
August 12, 2021
Among a second quarter results announcement full with setbacks, bluebird bio has revealed that it will exit the European market after failing to secure access for its gene therapy with various governments.
Minaris and bluebird bio Enter Manufacturing Pact contractpharma
July 23, 2021
The CDMO will be the commercial manufacturer in Europe for Skysona, bluebird bio’s gene therapy for CALD.
bluebird bio’s sickle cell gene therapy granted MHRA ‘innovation passport’ pharmatimes
July 01, 2021
bluebird bio’s gene therapy for sickle cell disease LentiGlobin has been granted an ‘innovation passport’ from the UK Medicines and Healthcare products Regulatory Agency (MHRA).
beti-cel gene therapy demonstrates durable efficacy in beta thalassaemia patients europeanpharmaceuticalreview
June 18, 2021
The betibeglogene autotemcel (beti-cel) gene therapy caused paediatric and adult beta thalassaemia patients to achieve transfusion independence lasting over two years.
Cross-industry alliance launches to increase awareness of cell and gene therapies in the UK pharmatimes
May 19, 2021
A new cross-industry alliance between leading pharma and biotech companies has launched in a bid to raise awareness and boost understanding of cell and gene therapies in the UK.
bluebird bio releases new data on its gene therapy for cerebral adrenoleukodystrophy europeanpharmaceuticalreview
March 17, 2021
Data from nearly seven years of follow up suggests one-time treatment with eli-cel may durably stabilise cerebral adrenoleukodystrophy disease progression.
bluebird bio’s beta-thalassaemia gene therapy rejected by NICE pharmatimes
February 20, 2021
bluebird bio’s beta-thalassaemia gene therapy betibeglogene autotemcel (beti-cel) has not been recommended by the UK’s National Institute of Health and Care Excellence (NICE) for use on the NHS.
Bluebird bags EU conditional marketing authorisation for Zynteglo pharmatimes
June 05, 2019
Bluebird bio has announced that its gene therapy Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) has been granted conditional marketing authorisation in Europe for certain patients 12 years and older with transfusion-dependent β-thalassaemi
Bluebird’s Zynteglo kicks off first Amsterdam CHMP recommendations pharmatimes
April 02, 2019
The first Amsterdam-based European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) meeting has been held, resulting in just one new initial marketing authorisation and three label extensions.
EU regulators to review bluebird’s gene therapy LentiGlobin pharmatimes
October 11, 2018
The European Medicines Agency will undertake an accelerated review of bluebird bio’s LentiGlobin, a gene therapy for the treatment of transfusion-dependent beta-thalassemia.

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