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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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R&D
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UK Government commits to long-term R&D funding
The announcement supports the UK government’s broader plans for reformation of longer-term funding for the research and development sector.
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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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Takeda investigational drug shows efficacy in narcolepsy
If approved, the oral medicine could provide a first-in-class treatment option for eligible individuals with the chronic 24-hour disease.
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GSK to expand hepatology pipeline with potential best-in-class therapy
The unique mechanism of action of efimosfermin supports its potential as a new standard-of-care in liver disease.
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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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Innovative CAR T therapy could deliver in broader therapeutic settings, research suggests
The novel cell therapy utilises a shortened manufacturing process compared to standard production timelines, offering potential for enhanced therapeutic capability.
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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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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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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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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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New $1.7b Novartis acquisition to advance novel microRNA inhibitor
The merger deal between Novartis AG and Regulus Therapeutics is expected to push forward development of a potential first-in-class kidney disease drug.
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Eli Lilly to lead oligonucleotide therapy development in new collaboration
The partnership between Eli Lilly and Company and Creyon Bio will focus on producing safer, more effective RNA-targeted oligonucleotide therapies with the use of AI technology.
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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.
