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European Pharmaceutical Review Issue 2 2025
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.
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Proteins
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NICE concludes decision for two Alzheimer’s treatments
The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.
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Enhancing chromatographic protein purification with light
The method offers an alternative approach for efficient control in affinity chromatography as a separation technique, researchers propose.
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New technology could enhance CAR T therapy manufacture
The innovative device could improve CAR T cell cancer immunotherapy and facilitate its use as a first-line therapy, research suggests.
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New J&J data signals progress in ulcerative colitis treatment landscape
The biologic delivered sustained remission in adults with the inflammatory bowel disease (IBD) over the two-year study, results show.
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Alzheimer’s drug requires strengthened pharmacovigilance approach
Ongoing real-world safety and effectiveness monitoring of the Alzheimer’s drug lecanemab is needed to protect patients long-term, drug safety researchers urge.
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Potential blockbuster drugs to watch in 2025
Eleven drugs are poised to make waves in the pharmaceutical industry in 2025, according to the annual report.
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FDA issues first recommendations on AI for drug development
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
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Bristol Myers Squibb licenses amyloid-beta antibody programme
The new agreement between Bristol Myers Squibb and BioArctic is set to advance development of anti-amyloid-beta antibody treatments, which have shown symptomatic benefit in Alzheimer's.
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Targeting ovarian cancer with a novel antibody therapeutic
Christina Pelizon, International Medical Affairs Head for Oncology at AbbVie discusses the significance and impact of the European Commission’s approval last month of Elahere® (mirvetuximab soravtansine) to treat ovarian cancer.
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New mass spectrometry Chapter could “revolutionise” biopharma quality assurance
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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Study proposes system to produce endotoxin-free recombinant proteins
The system is distinguishable from other bacterial expression systems and can be applied in scenarios where minimal endotoxin contamination is an issue, according to the research.
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Developing donanemab – balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
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Eli Lilly secures MHRA authorisation for Alzheimer’s treatment
Authorisation in Great Britain means eligible Alzheimer's patients can access the treatment, which is part of a new class of amyloid targeting therapies.
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Pharma Horizons: Biologics
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
