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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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Drug Safety
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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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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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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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Could investigational drug become first-in-class bronchiectasis therapy?
The small molecule treatment is currently being reviewed by the US Food and Drug Administration (FDA), under the Prescription Drug User Fee Act (PDUFA).
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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.
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Eli Lilly releases topline data for new oral GLP-1
Subject to regulatory approval, the small molecule drug could provide a new treatment option for diabetes and obesity, Eli Lilly’s new data suggests.
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New drug delivery method for cell therapies reported
Findings from the proof-of-concept study highlight the safety of the novel delivery system for patients who are ineligible for standard intravenous cell therapy.
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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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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.
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GSK to advance antibody medicines for neurodegenerative diseases
The licensing agreement will support development of medicines for delivery across the blood-brain barrier to treat neurological disorders like Alzheimer’s and Parkinson’s.
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Sampling system offers unique strategy for airborne bacterial detection
The proposed technique holds value for real-time monitoring and surveillance of airborne bacteria with high sensitivity and rapid results, the study showed.
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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.
