All Pharmacovigilance and safety oversight articles – Page 3
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ArticleNavigating evolving clinical and regulatory expectations as mRNA outgrows its vaccine roots
Jianbo Diao, PhD, Director of Bioanalytical Services, WuXi AppTec, discusses the importance for mRNA therapy developers of adopting precise and flexible analytical strategies for future pipeline success.
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NewsLilly wins European Alzheimer’s approval for Kisunla after regulatory setbacks
The anti-amyloid monoclonal antibody is part of the class of medicines representing the first disease-modifying therapies for the neurodegenerative disease.
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NewsOne-time gene therapy could “transform” Huntington’s treatment landscape
uniQure’s positive topline data “are the most convincing in the field to date” and indicate the gene therapy’s potential disease-modifying effects.
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NewsNovel analytical approach could aid quality control during nitrosamine analysis
The innovative approach facilitates QSRR-assisted chromatographic development for N-nitrosamine analysis in pharmaceutical products.
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NewsBayer claims cell and gene therapy first in Parkinson’s research
Advances cell therapy and gene therapy candidates, with both showing neurorestorative potential against the disease.
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NewsNovo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval
EMA advisors at the CHMP backed the combination treatment and also recommended Bayer’s menopause drug Lynkuet, putting both on the path to being licensed.
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ArticleMicrobiology/RMM In-Depth Focus 2025
This in-depth focus features articles on rapid microbiological methods, quality control, and using AI to read agar plates.
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ArticleGuide to Outsourcing 2025
Doug Botkin, PhD Scientific Portfolio Specialist from Charles River Laboratories, examines how modern microbial ID tools can enhance contamination control strategies and the benefits an outsourcing partner can provide.
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ArticleEuropean Pharmaceutical Review Issue 3 2025
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
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NewsBiogen wins European first for depression drug Zurzuvae
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
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NewsCPHI Pharma Awards 2025 finalists announced
Winners of this year's awards will be revealed during the opening of CPHI Frankfurt 2025.
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NewsICH to implement M14 Guideline for post-marketing safety submissions
The ICH Assembly’s decision supports progress in promoting international standards for safety assessment of medicines.
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NewsFDA approves first-of-a-kind intravesical drug delivery system for bladder cancer
The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.
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FDA to modernise review process for developers of ultra-rare diseases
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.
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NewsRoche en route to first continuous delivery treatment for nAMD in Europe
CE mark for Contivue platform supports its ambitions for Susvimo in age-related macular degeneration (AMD).
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NewsFDA waives trial requirement for Stelera biosimilar, easing the copycat’s path
First-of-its-kind case continues EMA and MHRA harmonisation, streamlining the global biosimilar approval pathway.
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Teva wins US obesity approval for its GLP-1 generic liraglutide
And Eli Lilly and Company’s new oral GLP-1 obesity therapy orforglipron shines in late-phase clinical trials.
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NewsMHRA pilot to prepare sponsors for clinical trial regulation changes
The Route B notification pilot will expand the MHRA’s risk-proportionate approach and help prepare for a new modifications process under upcoming regulations.
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NewsPharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
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Late-stage trial boost for Argenx’s myasthenia gravis drug Vyvgart
The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.