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- PMLiVE

LentiGlobin

- PMLiVE

EC approves BMS cell therapy for multiple myeloma

The approval of Abecma is based on “rapid, deep and durable” trial responses

- PMLiVE

Gene therapy company bluebird bio quits Europe

The decision comes after a trial in a rare neurological disease is halted over safety concerns and the FDA has placed the eli-cel programme on clinical hold

- PMLiVE

Resilience acquires bluebird bio’s manufacturing facility as part of cell therapy alliance

The two companies plan to collaborate on the ‘next phase’ of bluebird bio's spin-off oncology cell therapy company 2seventy’s pipeline

- PMLiVE

EU approves bluebird bio’s CALD gene therapy Skysona

CALD is a progressive and fatal neurodegenerative disease that overwhelmingly affects males

- PMLiVE

EMA begins rolling review of Sanofi, GSK’s COVID-19 vaccine

Rolling review launched based on preliminary results from lab studies and early clinical studies

- PMLiVE

bluebird bio to restart marketing of Zynteglo in EU after previous suspension

EMA’s safety committee PRAC has confirmed favourable risk-benefit balance of gene therapy

- PMLiVE

bluebird bio lodges counterclaim against Spark Therapeutics

Spark previously accused bluebird of misusing trademarks relating to the word ‘spark’ in marketing/educational materials

- PMLiVE

MHRA grants bluebird bio’s LentiGlobin gene therapy an ‘innovation passport’

The Innovative Licensing and Access Pathway scheme aims to help speed approval of innovative treatments

- PMLiVE

CHMP recommends eight new medicines for EU approval

BMS’ CAR T therapy Abecma and BioMarin’s dwarfism drug Voxzogo among positive recommendations

- PMLiVE

bluebird bio presents new data for beti-cel in beta thalassemia at EHA2021

Gene therapy shows sustained efficacy across paediatric and adult patient populations

- PMLiVE

BMS, Acceleron’s Reblozyl shows new improvements for beta thalassemia patients

The data, presented at the EHA 2021 virtual congress, shows a 77% haemoglobin increase in patients treated with Reblozyl

- PMLiVE

FDA lifts clinical hold on bluebird bio’s LentiGlobin studies

Company previously put trials on hold after suspected unexpected serious adverse reactions

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