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Roche 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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Drug Safety
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CHMP 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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Major 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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FDA 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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Measuring 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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New 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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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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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.
