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- PMLiVE

CALD gene therapy

- 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

FDA lifts clinical hold on bluebird bio’s LentiGlobin studies

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

- PMLiVE

FDA approves Biogen’s aducanumab for Alzheimer’s disease in ‘landmark’ decision

FDA is requiring Biogen to conduct a new randomised, controlled clinical trial to verify the drug’s clinical benefit for Alzheimer’s patients

- PMLiVE

Moderna seeks full FDA approval for its COVID-19 vaccine

Moderna's mRNA-based vaccine is currently authorised for emergency use in the US

- PMLiVE

BMS’ Zeposia gains FDA approval in ulcerative colitis

Treatment was initially approved in 2020 for multiple sclerosis

- PMLiVE

FDA panel backs Provention Bio’s type 1 prevention drug teplizumab

Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) narrowly voted in favour of supporting approval of the drug

- PMLiVE

FDA priority review granted for J&J, Legend Biotech’s myeloma CAR T therapy

CAR T therapy demonstrated an overall response rate of 97% in relapsed/refractory multiple myeloma patients after 12.4 months

- PMLiVE

bluebird bio’s CALD gene therapy Skysona gains positive opinion from CHMP

CHMP's marketing authorisation recommendation is a step towards gaining EU approval

- PMLiVE

FDA approves Apellis’ Empaveli for rare blood disease

PEGASUS study results show Empaveli is better than Soliris at improving haemoglobin levels

- PMLiVE

New court filing alleges Sanofi destroyed emails relating to Zantac recall

Drugmaker began recalling heartburn drug in 2019 after link to probable human carcinogen

- PMLiVE

Emergency authorisation for Pfizer/BioNTech vaccine expanded in the US

Data from a study involving 12 to 15 year olds has also been submitted to the EMA for potential approval

- PMLiVE

Pfizer, BioNTech file for full US approval of COVID-19 vaccine

Pfizer chief executive Albert Bourla said last week the company is on track to supply 2.7bn doses in 2021

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