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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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Clinical Development
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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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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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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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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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Boehringer agrees new partnership to advance first-in-class precision cancer therapies
The collaboration between Boehringer Ingelheim and Tessellate Bio seeks to address availability of targeted medicines for a cancer type shown to be difficult to treat.
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Antibody treatment demonstrates potential in lupus kidney disease
The findings suggest that the biologic treatment could improve short-term outcomes for patients with lupus nephritis.
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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.
