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- PMLiVE

Skysona

- PMLiVE

bluebird bio marks Rare Disease Day 2021 with launch of patient testimonial video

Personal stories from nine patients from seven European countries, aged between 4 and 61, shed light on the impact of living with thalassaemia

- PMLiVE

FDA briefing document backs J&J’s one-dose COVID-19 vaccine

Company is seeking an emergency use authorisation in the US

- PMLiVE

FDA updates guidance for COVID-19 vaccine makers addressing new variants

FDA said that it expects manufacturing information for modified vaccines to remain generally the same

- PMLiVE

bluebird bio posts modest Q4 revenue growth as it continues investigation into troubled LentiGlobin

Company announced clinical hold on gene therapy earlier this month after suspected serious adverse reaction

- PMLiVE

FDA fast-tracks review of Incyte’s Jakafi for chronic GVHD

Submission is based on results from the pivotal REACH3 study

- PMLiVE

AZ withdraws Imfinzi in the US for advanced bladder cancer after post-marketing study fail

Immunotherapy failed to hit primary endpoint in phase 3 DANUBE trial last year

- PMLiVE

bluebird bio temporarily suspends trials of sickle cell gene therapy LentiGlobin

Company will also suspend marketing of beta-thalassemia gene therapy Zynteglo

- PMLiVE

NICE turns down bluebird bio’s gene therapy Zynteglo

Draft guidance does not recommend routine NHS funding for beta thalassaemia treatment

- PMLiVE

ICER extends evaluation of Biogen’s aducanumab after FDA delay

FDA delayed its decision on potential Alzheimer's therapy to 7 June

- PMLiVE

FDA grants emergency use for Lilly’s COVID-19 antibody drug combination

Bamlanivimab plus etesevimab shown to reduce risk of death in high-risk COVID-19 patients

- PMLiVE

FDA considers new safety warnings for Pfizer’s JAK inhibitor Xeljanz

Post-marketing study shows increased risk of serious heart-related problems and cancer with Xeljanz

- PMLiVE

FDA schedules meeting on 26 February to review J&J’s one-dose COVID-19 vaccine

Vaccine candidate demonstrated an overall efficacy of 66% in phase 3

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