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FDA approves Ebanga (Ansuvimab-zykl) for the treatment of Ebola
Ebanga was approved based on its ability to reduce 28-day mortality in patients with confirmed Ebolavirus infection.
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Regulation & Legislation
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Factsheet: Total Organic Carbon (TOC) back to basics
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
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First long-acting HIV treatment approved in Europe
The European Commission approval of the long-acting injectable HIV treatment could transform the lives of people living with the disease.
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Concerns raised over India’s approval of COVID-19 vaccine with incomplete data
The All India Drug Action Network has said it is "shocked" India has given approval to Covaxin, a COVID-19 vaccine with a lack of peer reviewed safety and efficacy data.
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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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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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Abbott receives CE mark for COVID-19 IgG quantitative antibody blood test
The new quantitative SARS-CoV-2 IgG lab-based serology test developed by Abbott has been given the CE mark.
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Class 4 Medicines Defect: missing safety information in some Perindopril products
The MHRA reports that certain packs of Perindopril products are missing important safety information, the products are not being recalled.
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Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon and conductivity data
Cleaning validation is an important element to current good manufacturing practice (cGMP) manufacturing to ensure purity, quality and potency of drug product. Above all, patient safety is the primary concern.
![Vials labelled 'COVID-19 Vaccine Pfizer' [Giovanni Cancemi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-covid-19-vaccine-300x278.jpg)
![Vials labelled 'COVID-19 Vaccine Pfizer' [Giovanni Cancemi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-covid-19-vaccine-scaled-e1607955047519.jpg)
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FDA grants Emergency Use Authorization for Pfizer’s COVID-19 vaccine BNT162b2
The US has approved emergency use of Pfizer and BioNTech’s COVID-19 vaccine, BNT162b2, in people 16 years of age and older.
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Where now with quality by design?
Dave Elder discusses whether the goals of QbD have truly been met and questions whether the complex processes, lack of clarity and high costs have resulted in the promised global harmonisation.
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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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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.
