All Pharmacovigilance and safety oversight articles – Page 5
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NewsiPSC-CAR-NK cell therapy exhibits autoimmune potential
The genetically edited allogeneic product could serve as an immune-modulatory therapy for severe autoimmune diseases, data suggests.
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NewsRegulatory shift signals potential change for future CGT sector
The cell and gene therapy (CGT) sector must maintain its scientific rigor despite recent changes to US policy and market conditions, says key industry body.
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NewsNICE concludes decision for two Alzheimer’s treatments
The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.
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NewsMHRA Class 2 medicine recalls – May/June 2025
The UK medicine agency's most recent recalls of this class have been due to packaging and potential contamination issues.
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NewsLancet study illustrates drug delivery “milestone”
The oral pill could address common drug adherence challenges in conditions such as schizophrenia, the clinical trial findings suggest.
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NewsFDA grants expanded approval for hepatitis drug
The FDA’s authorisation helps to address the “significant” remaining need for acute hepatitis C treatments, according to AbbVie.
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NewsDuchenne gene therapy interim trial outcomes “striking”
The gene therapy demonstrated consistent evidence of positively changing disease trajectory in Duchenne muscular dystrophy, new interim data shows.
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NewsMHRA issues first UK guidance on phage therapies
MHRA’s publication is intended to support European developers of phage-based medicinal products to effectively navigate related regulations.
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ReportPharma Horizons: environmental monitoring
This exclusive report addresses the key obstacles and innovations shaping pharmaceutical environmental monitoring, from QC and contamination control, to the impact of advanced technologies and regulatory changes. Discover practical solutions you can implement to drive progress for your organisation.
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NewsRoche reports long-term capabilities of multiple sclerosis drug
The BTK inhibitor enabled near-complete suppression of disability progression for up to two years in individuals with relapsing multiple sclerosis (RMS), the new findings reveal.
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NewsCHMP meeting highlights - May 2025
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
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NewsMajor trial indicates potential of novel hypertension drug
The demonstrated safety and efficacy of the aldosterone synthase inhibitor suggest its potential in helping patients with hypertension to reach their blood pressure goal, according to the data.
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NewsFDA approval marks shift in diabetic retinopathy treatment
The ocular injection, now granted its third FDA approval, offers a more convenient treatment option for patients with vision loss.
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ArticleMeasuring AI’s impact on the pharmaceutical industry
In this article, Updesh Dosanjh, Practice Leader, Pharmacovigilance Technology Solutions, IQVIA, explores how the pharmaceutical industry and its workforce can truly leverage the potential of artificial intelligence (AI) and measure the impact of this technology.
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NewsNew real-world data guidance could accelerate drug approvals
The MHRA’s consultation, announced on International Clinical Trials Day, is intended to support creation of innovative UK trials.
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NewsTakeda 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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NewsInnovative 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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ArticleQualification 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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NewsNew 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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NewsCHMP 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.