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Have your say on future UK clinical trial legislation
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on far-reaching proposals to revise the clinical trial legislation in the UK.
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Drug Safety
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![Gilead sign at their headquarters in Silicon Valley, California USA[Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Gilead-2-e1642427117214.jpg)
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Gilead joins the Association of the British Pharmaceutical Industry
With the Association of the British Pharmaceutical Industry (ABPI), Gilead Sciences will work to tackle health crises and shape international trade and regulation.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, January 2022
The EMA’s pharmacovigilance committee (PRAC) began reviewing terlipressin containing medicines and recommended updates to COVID-19 vaccine safety information.
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Promising results for COVID-19 and pneumococcal vaccine co-administration
Pfizer reveals co-administering its Prevnar 20™ pneumococcal vaccine and a booster dose of Comirnaty® COVID-19 vaccine was safe and immunogenic.
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NICE recommends Rinvoq® for adults with active psoriatic arthritis
AbbVie’s Rinvoq® (upadacitinib) will be available on the NHS in England and Wales for adults with active psoriatic arthritis, following NICE approval.
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Graft engineering sees potential to reduce GVHD risk in leukemia patients
New study shows risk of developing graft-versus-host disease (GVHD) in leukaemia patients reduced by removing naïve T cells from donor blood used for stem cell grafts.
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Ensovibep shows promise as an antiviral for COVID-19
Phase II trial data suggests ensovibep (MP0420) significantly reduces SARS-CoV-2 viral load and reduces hospitalisation and death due to COVID-19.
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European Commission approves Lumykras® for lung cancer treatment
Amgen’s Lumykras® (sotorasib) has been approved for adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation.
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New strategy could improve generic drug quality assessments
Population pharmaceutical quality assessment could be used to improve the quality consistency of generic drugs, suggests study.
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Event review: The Future of QA/QC for Complex Biologics
On 30 November and 1 December 2021, European Pharmaceutical Review hosted its first ever event – The Future of QA/QC for Complex Biologics Online Summit. Bringing together more than 600 attendees, 15 expert speakers and Thermo Fisher Scientific and Merck as sponsors, the summit gave industry experts the chance to…
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New developments in the pharmaceutical stress testing industry
A team of American scientists report on some recent developments in the realm of pharmaceutical stress testing, or forced degradation, practices relating to solid dosage forms, bringing some valuable clarity for drug developers.
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Critical steps when validating an assay or analytical method for cell and gene therapy products
Dr Kiren Baines, Analytics Lead at eXmoor Pharma, details some of the critical steps when validating an assay or analytical method, including key considerations for developing an experimental plan aligned with ICH guidelines.
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It’s not just a box
At first glance pharmaceutical packaging such as a tablet carton or medicine bottle appears to be the simplest of things. However, the humble package serves multiple and varied needs and increasingly includes a surprising range of technology. Reddie & Grose LLP’s Zack Mummery, Dale Carter and Andy Attfield explain more.
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First drug for acute graft-versus-host disease prevention approved by FDA
BMS’s Orencia (abatacept) has been approved by the US FDA for prophylaxis of acute graft-versus-host disease (aGvHD) in patients aged two years plus.
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EMA recommends GSK’s Xevudy for the treatment of COVID-19
The EMA has recommended granting marketing authorisation for the use of Xevudy (sotrovimab) to treat COVID-19 in adults and adolescents.
