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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

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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

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UK announces new ten-year Life Sciences Vision to support life sciences sector

UK government has launched a £200m life sciences investment programme to support innovative life sciences companies

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MHRA outlines two-year delivery plan with ‘patient first’ focus

New delivery plan also outlines strategy for UK regulatory body following Brexit

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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

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CHMP recommends eight new medicines for EU approval

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

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Global consortium of medicines regulators reveals new strategic plan

Access Consortium includes regulators from Australia, Canada, Singapore, Switzerland and the UK

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J&J’s single-dose COVID-19 vaccine secures approval from the UK’s MHRA

Vaccine was found to be 67% effective in preventing COVID-19 infection in a phase 3 study

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EMA authorises Pfizer/BioNTech’s COVID-19 vaccine for children aged 12 to 15

Clinical trial data recently showed that the vaccine is safe and effective in individuals in this age group

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

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

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Pfizer asks UK’s MHRA to approve its COVID-19 vaccine in adolescents

The vaccine has been authorised in the US for 12- to 15-year-olds

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EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

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