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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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Regulation & Legislation
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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.
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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.
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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.
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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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Ways to promote patient access as a European healthcare priority
We are experiencing a time of polarity in our healthcare systems with breakthrough treatment options developed, but access prohibited. Here, Catherine Owen, SVP of Major Markets at Bristol Myers Squibb, explains why, despite continued COVID-19 pressures, the time is ripe to rectify this situation.
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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.
