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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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Regulation & Legislation
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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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Accelerating Clinical Trials in the EU (ACT EU) initiative launch
The new ACT EU initiative seeks to transform how clinical trials are initiated, designed and run in the European Union.
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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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Kaftrio® with ivacaftor approved by EC to treat children with cystic fibrosis
Children with cystic fibrosis aged six to11 years could benefit from Kaftrio® in combination with ivacaftor, as a treatment targeting the underlying cause of the disease.
webinar
The path forward — Altasciences’ approach to project management
11 January 2022 | By Altasciences
Discover the opportunities Altasciences' hybrid approach to project management can offer your drug development programme.
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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.
whitepaper
Infographic: Solutions for your cleanroom facility
Our customised microbial solutions ensure your cleanroom is compliant and free of contamination to manufacture safe and effective products.
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Nearly two years on, how are European pharma supply chains coping with COVID-19?
When the pandemic broke out in 2020, pharmaceutical supply chains showed signs of potential failure across the continent. Now, with COVID-19 cases rising once more, and an end to the problem not yet in sight, we discuss with Medicines for Europe how these supply chains are faring, almost two years…
whitepaper
Technical note: System precision in HPLC analysis of APIs and impurities
HPLC users expect robust, reliable systems with equivalent performance and reproducibility between systems that greatly facilitates method transfer.
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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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United efforts to accelerate drug development
From the Cancer Drug Development Forum (CDDF), John Smyth (Chairman), Axel Glasmacher (Treasurer) and Jaap Verweij (Managing Director) clarify the importance of a collaborative industry approach to cancer therapy development and highlight the most pressing challenges for discussion in their meetings and workshops.
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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.
