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EMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
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Innovative framework could enhance process efficiency in manufacturing quality control
The proposed approach demonstrates benefit for real-world application, establishing more robust, adaptive, and economical process systems, the research suggests.
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Pharma Horizons: Artificial Intelligence
EPR's latest Pharma Horizons report explores the latest advances in artificial intelligence (AI) for drug and clinical development, regulation and more.
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Optimal biosafety cabinet cleaning strategy proposed
The research highlights a potential approach to address cross-contamination challenges during cell-processing operations.
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Innovating intelligent cleanroom control systems
The proposed technique outperformed traditional controllers, supporting improved air quality control in cleanrooms, according to the study.
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Drug for rare form of Alzheimer’s “scientifically promising”
The anti-amyloid drug study highlights the importance of longer-term follow-up to determine benefits and risks of dementia treatments.
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European Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
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Nanomaterial research potential “game-changer” for drug delivery
The throughput achieved by the researchers exceeded that of other reported methods by orders of magnitude, supporting the advancement of precision nanomaterials.
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NICE recommends innovative endometriosis pill
Approximately 1,000 eligible NHS patients could benefit from the new endometriosis treatment annually.
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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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Vulnerable medicine list to aid US medicine supply resilience
The analysis from the US Pharmacopeia (USP) provides a mitigation strategy for manufacturers and other stakeholders to improve reliability of medicines amidst supply chain challenges.
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CHMP meeting highlights – February 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines plus the extension of therapeutic indications for 16 medicines.
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Imaging discovery could accelerate drug development
The organic fluorophore’s super-photostability enables tracking of previously undetectable biological processes hindered with traditional fluorescent dyes.
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Could novel 3D printing method enhance intestinal drug delivery?
The research suggests that the innovative 3D printing method has “great” potential for personalised treatments of intestinal inflammatory diseases.
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Greener method for ethylene oxide manufacture identified
The cleaner method could significantly lower production costs and reduce carbon dioxide emissions resulting from ethylene oxide manufacturing.
