All Pharmacovigilance and safety oversight articles
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ArticleOptimising the downstream process in lentiviral vector manufacturing
Sartorius BIA Separations illustrates a promising alternative approach for efficient lentiviral vector purification that delivers a scalable, GMP-ready biomanufacturing solution.
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NewsSana's islet cell transplant therapy shows early promise in type 1 diabetes
Biotech company’s long-term data demonstrated hypoimmune (HIP)-modified islet transplantation without immunosuppression in type 1 diabetes.
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NewsBlueprint’s rare disease drug Ayvakit shows long-term benefit
D816V-targeted therapy provided robust symptom control in patients with indolent systemic mastocytosis, supporting its use as a long-term treatment.
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NewsFDA drafts new ultra-rare disease therapy guidance
Agency’s planned framework is the first to support the approval process for new ultra-rare disease treatments.
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NewsFDA policy sets new clinical trial requirements for drug approvals
The default standard would see US drug and biologic approvals require a single, robust pivotal study plus confirmatory evidence, instead of two trials.
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NewsSanofi’s Beyfortus shows infant benefit beyond first RSV season
The biologic enabled a significant reduction in RSV-related hospitalisations in infants through a second RSV season.
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NewsNovartis bolsters the case for Vanrafia’s full approvals in IgA nephropathy
Phase III results will support the firm’s planned filings for traditional approvals later in 2026, following last year’s US and China accelerated approvals.
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NewsGSK’s Nucala green lit for COPD in expanded EU approval
The EC's decision opens up the monthly biologic for use by COPD patients with an eosinophils phenotype.
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NewsAstraZeneca’s Imfinzi plus chemotherapy earns CHMP nod in gastric cancer
If approved, the regimen would become the first immunotherapy-based perioperative therapy for adults with early gastric and gastroesophageal cancers in Europe.
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NewsRoche GLP-1 produces “robust” weight loss in late-stage obesity trial
The pharma company’s injectable GLP-1/GIP receptor agonist CT-388 is an important element of its weight loss strategy and also delivered benefits for pre-diabetic patients.
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NewsHoth Therapeutics’ topical therapy shines in cancer toxicity trial
Achieves 100 percent response in phase II data highlighting HT-001's potential as a supportive oncology treatment to address a common EGFR therapy burden.
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NewsJohnson & Johnson’s Caplyta demonstrates phase III promise for depression
Combination therapy comprising of an antidepressant and small molecule drug significantly boosted remission rates in adults with major depressive disorder.
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NewsTeva’s migraine biologic Ajovy marks phase III progress for paediatric patients
The monoclonal antibody could provide a new preventative treatment option for episodic migraines, new late-stage data suggests.
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ArticleProven strategies for cleanroom and water system qualification success
The critical role of identification and documentation in contamination control.
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NewsEuropean Pharmacopoeia publishes new data quality framework
New general chapter on quality of data 5.38 supports stakeholders with digitalisation during pharmaceutical quality decision-making.
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NewsChemical assessment in Europe to be streamlined under new legislation
The European Commission’s new framework aims to improve safety assessment of chemicals to better protect human health and the environment.
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NewsEndotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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NewsGeneric manufacturer safety records revealed by new consumer app
News organisation ProPublica’s Rx Inspector tool connects FDA information on factory location and regulatory records to individual generic drugs.
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NewsAstraZeneca and Daiichi’s Enhertu wins first-in-decade US oncology approval
FDA approval of the drug in combination with Perjeta initiates a $150 million milestone payment to Daiichi Sankyo from AstraZeneca under their joint collaboration.
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NewsAI-discovered IL-17 inhibitor from Ascletis Pharma shows best-in-class potential
New phase I data suggests the oral small molecule ASC50 could help address immunology conditions such as psoriasis.