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clinical trials

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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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AstraZeneca clears latest hurdle for Alexion acquisition after EU clearance

AZ first announced the proposed acquisition of Alexion in December 2020

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EU identifies first five ‘promising’ COVID-19 drugs as part of therapeutics strategy

The five therapeutic candidates include a repurposed arthritis med and monoclonal antibodies

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Understanding the authentic patient experience can redefine the success of your clinical trial before you design it

. Su contributes our experience are Origins that there is a willingness within the Pharmaceutical Industry to change attitudes towards clinical trial populations – making them less about academic and...

Origins – The Patient Focused Specialists

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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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BMS’s oral AML therapy Onureg receives EU approval

Onureg is the oral version of Vidaza, two of the drugs BMS gained as part of its acquisition of Celgene in 2019

Sanofi reception

Sanofi’s oral therapy Aubagio approved in the EU for paediatric MS patients

EC approval comes a few weeks after the FDA rejected Aubagio in the same patient population

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Court rules on AZ and EU’s COVID-19 vaccine dispute

The Court in Brussels has ordered AZ to deliver a total of 80.2 million doses to the EU by 27 September 2021

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AZ’s Tagrisso approved for EGFR-positive NSCLC in the EU

European Commission approved Tagrisso in this setting based on positive results from the ADAURA phase 3 study

The Future of Digital Pills

Valerie Sullivan, President and CEO at etectRx, dives into digital pills in healthcare and clinical research. Among many other things, we discuss how Pharma companies can benefit from the ability...

Impetus Digital

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EU takes legal steps against AZ over delayed COVID-19 vaccine deliveries

Lawyers for the European Commission have asked the court to fine AZ €10m per infraction

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