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New real-world data guidance could accelerate drug approvals
The MHRA’s consultation, announced on International Clinical Trials, is intended to support creation of innovative UK clinical trials.
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Regs & Legs
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Pharma Horizons: the future of cell and gene therapy
EPR's latest Pharma Horizons report explores the latest advances in cell and gene therapy for quality control, manufacturing, analytical development and more.
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UK immigration reform – implications for life sciences
This article offers key industry perspectives on the UK government’s recent immigration whitepaper and highlights the challenge of balancing economic growth and attracting skilled talent.
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World-first approval supports AstraZeneca’s sustainability goals
Approval of the novel tool marks progress for both respiratory disease patients in the UK and reducing the global environmental impact of inhaled medicines.
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Tackling EU supply chain challenges while boosting innovation
Medicines for Europe calls for continued progress of pharmaceutical reforms such as the Critical Medicines Act, to support production of essential medicines in the region.
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Qualification of non-mutagenic impurities (NMIs)
In this article, Dave Elder reviews the European Medicines Agency (EMA)’s updated reflection paper on the qualification of non-mutagenic impurities (NMIs), which outlines alternative approaches to animal testing.
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Landmark UK-India trade deal insufficient for life sciences, says industry body
The multi-billion-pound deal provides a boost to the UK’s economy, however it lacks provision to aid the country’s growth ambitions, states the ABPI.
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Improving EU’s regulatory framework for enhanced pharma competitiveness
Despite its potential to become a more attractive destination for drug developers, new research insists the EU market makes improvements such as faster regulatory approvals and closer collaboration.
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FDA approves first-of-a-kind gene therapy for dystrophic epidermolysis bullosa
With clinical data showing the gene therapy can address large and challenging chronic wounds, the FDA’s decision will help improve quality of life for dystrophic epidermolysis bullosa (DEB) patients.
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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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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.
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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.
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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.
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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.
