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EMA begins rolling review of Novavax’s NVX-CoV2373 COVID-19 vaccine
The review will evaluate data from preclinical and clinical studies of NVX-CoV2373 to expedite the vaccine’s marketing authorisation approval later.
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European Medicines Agency (EMA)
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EMA initiates rolling review of Regeneron’s COVID-19 mAb
The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
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EMA committee recommends 13 medicines for approval in January meeting
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
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Sotorasib shows success against non-small cell lung cancer in Phase II trial
In a Phase II trial, sotorasib was shown to be effective against pre-treated non-small cell lung cancer (NSCLC).
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EMA accepts MAA for Oxbryta to treat haemolytic anaemia in sickle cell disease
The EMA has accepted Global Blood Therapeutics' marketing authorisation application for Oxbryta (voxelotor) to treat haemolytic anaemia in sickle cell disease.
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Cannabinoid series: medicinal cannabis and Brexit
Sarah Ellson from Fieldfisher spoke with European Pharmaceutical Review to discuss the position of medicinal cannabis in the UK and the impacts of Brexit.
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EMA receives authorisation application for AstraZeneca COVID-19 vaccine
The EMA has received a conditional marketing authorisation application for the Oxford-AstraZeneca COVID-19 vaccine.
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European Commission approves Moderna’s COVID-19 vaccine
Moderna's COVID-19 vaccine has been approved in the EU with a conditional marketing authorisation by the European Commission.
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The rise of biosimilars – navigating regulatory complexity in Europe
Gabriela Marton sets out some of the EU-associated regulatory challenges life sciences companies will need to navigate if they want to take advantage of the rise of biosimilars.
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Seven secret ingredients for successfully launching and commercialising a biopharma’s first drug in Europe
After the US, Europe is considered the second most attractive market for serving patient needs while realising commercial value from innovative drugs. However, the 27 EU member states each have their own approaches to pricing and market access – and need tailored commercialisation and go-to-market strategies. Simon-Kucher & Partners analysed…
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EC orders additional 80 million doses of Moderna’s COVID-19 vaccine
Europe will receive an extra 80 million doses of Moderna's mRNA-1273, a COVID-19 vaccine candidate, following the EC's decision.
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Pioneering a full-ecosystem microbiota approach to improve survival outcomes in life-threatening diseases
The human gut contains the largest ecosystem of microbial species having complex host-microbiome interactive networks that contribute to our physiology and regulate our immune system. An imbalance in this host-microbiome interaction is associated with disease and the ability to restore or stabilise the network by introducing a rich and diverse…
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EMA recommends 15 medicines for approval following December meeting
The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
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Pfizer’s COVID-19 vaccine data accessed in EMA cyber-attack
Pfizer and BioNTech told that documents relating to their COVID-19 vaccine approval were accessed during a cyber-attack on the European Medicines Agency (EMA).
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The future of RIM is cross-functional integration
By digitalising manual workflows and leveraging machine-learning algorithms to monitor events and offer data-driven insights, automation and AI can make regulatory information management (RIM) more effective and less time-consuming.
