news
USP boosts support for AAV-based gene therapy manufacturers
Alongside publication of the proposed General Chapter < 1067 >, the new resources from USP aim to help advance AAV gene therapies.
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Regs & Legs
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CHMP meeting highlights – April 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of a variety of new medicines, including several treatments for hereditary and rare conditions.
news
FDA approves novel therapy for chronic skin condition
The US approval could improve outcomes for eligible patients with previously limited options for managing the inflammatory skin condition.
news
European Commission Alzheimer’s drug approval marks advancement for EU patients
Lecanemab is the only approved Aβ monoclonal antibody that highly binds to and clears toxic protofibrils with high selectivity.
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New EU guidance seeks to address radiopharmaceutical supply chain vulnerabilities
The recommendations are issued amid increasing pressure on the complex supply chain for radiopharmaceuticals, medicines which are used to treat conditions such as cancer.
article
Regulating decentralised manufacturing in the UK – a legal perspective
Harry Jennings, Partner at VWV, discusses the UK's new framework governing point of care (POC) and modular manufacturing and its implications for manufacturers and marketing authorisation holders in the UK.
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NICE recommends new combination breast cancer drug
The agency’s recommendation could provide eligible breast cancer patients with a treatment that analysis suggest is to likely to work as well as two medicines already recommended by NICE.
webinar
Reflections and future opportunities in pharmaceutical microbiology
11 April 2025 | By European Pharmaceutical Review
During this virtual panel, industry experts will explore the major challenges, promising innovations and key trends impacting pharmaceutical microbiology.
news
New analysis sets stage for improved UK clinical trials
Observations from the report will help the MHRA to strengthen clinical research and lay the foundation for accelerated innovation and medicine delivery to patients in the UK.
article
Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers
Courtney Soulsby, Sector Development Director, Healthcare at the British Standards Institute, reveals how the industry can prepare for PFAS regulations now to get ahead of the curve.
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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing
Colleagues from biopharmaceutical company MSD reveal what it takes to fully realise the benefits of PAT implementation.
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The key role of GMP analytical testing for drug products
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
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AI in pharmaceutical development: hype or panacea?
Dave Elder reflects on the array of applications for AI to facilitate successful drug development, though proof remains elusive.
news
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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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.
