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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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Industry Insight
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Creating a COVID-19 Safety Toolkit for pharmaceutical businesses
Marta Kalas explains how to develop a COVID Safety Toolkit to ensure pharmaceutical businesses comply with changing regulations.
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NICE initiates new Innovative Licensing and Access Pathway for medicines
The new pathway developed by NICE for medicines to go from clinical trials to NHS patients is now in action.
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Protein crystallisation and crystallography market to reach almost $2 billion
Growth of the global protein crystallisation and crystallography market is attributed to increasing interest in biologics, more investment and advancing technologies.
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First patient receives Oxford-AstraZeneca COVID-19 vaccine
Brian Pinker was the first person to receive AZD1222, the COVID-19 vaccine developed by the University of Oxford and AstraZeneca, this morning.
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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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New opportunities for the global API market
Active pharmaceutical ingredients (APIs) are primary components in the manufacture of drugs, yet this global market experiences numerous challenges. Regulatory pressure, pricing arbitrages, a shift to digital manufacturing and patents for blockbuster drugs are chief among them, but the COVID-19 pandemic added a further hurdle as governments globally decided to…
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The Editors’ views: European Pharmaceutical Review’s 2020 round-up
Junior Editors of European Pharmaceutical Review, Hannah Balfour and Victoria Rees, discuss some of the most noteworthy news and announcements from this year.
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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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Noncommunicable diseases are leading cause of death and disability worldwide, says WHO
Alzheimer’s and diabetes enter the top ten global causes of death for the first time, while HIV/AIDS and tuberculosis deaths fall, according to the WHO’s 2019 Global Health Estimates.
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EMA and HMA publish joint strategy on medicine regulation for next five years
The EMA and HMA have published their joint strategy for the next five years, detailing how the regulatory network can continue the supply of safe and effective medicines.
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Report finds UK Vaccine Taskforce worked “decisively” in fight against COVID-19
An independent review has outlined the achievements of the UK's Vaccine Taskforce, finding it worked "at great pace" to bring a COVID-19 vaccine to patients.
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First person receives Pfizer and BioNTech COVID-19 vaccine in UK
A 90-year old woman is the first person to receive BNT162b2, the Pfizer and BioNTech COVID-19 vaccine, outside of clinical trials.
