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- PMLiVE

EU marketing authorisation

- PMLiVE

Biogen retracts EMA application for Alzheimer’s drug Aduhelm

The application was pulled after the CHMP said the data provided was not enough to support a marketing authorisation

- PMLiVE

EMA and ECDC publish advice on fourth doses of mRNA COVID-19 vaccines

The regulators have concluded that there is not enough supporting evidence for an immediate fourth dose

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EMA establishes DARWIN EU Coordination Centre

The new centre will give the EMA and other EU member states access to reliable, real-world evidence for EU medicine assessments

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EMA proposes EU clinical trial reforms

The ACT EU paper provides a list of regulatory network objectives, priorities and governance strategies for 2022-2023

- PMLiVE

Future of MHRA uncertain amid Brexit-fuelled shake up

Trade unions and regulatory experts warn that budget and staff cuts may lead to drug approval delays or the UK regulator simply rubber-stamping EMA decisions

- 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

CHMP recommends eight new medicines for EU approval

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

- PMLiVE

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

- PMLiVE

EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine

Safety committee finds possible link to ‘very rare cases’ of unusual blood blots with low blood platelets

- PMLiVE

J&J delays EU COVID-19 vaccine rollout following pause in the US

FDA and CDC recommended pausing rollout in US after reported cases of rare blood clots in vaccinated individuals

- PMLiVE

New restrictions for AZ/Oxford COVID-19 vaccine despite EMA endorsement

Regulators in Canada and Germany have reportedly placed new restrictions on vaccine

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