All Drug Development articles – Page 14
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ArticleICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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NewsBristol Myers Squibb licenses amyloid-beta antibody programme
The new agreement between Bristol Myers Squibb and BioArctic is set to advance development of anti-amyloid-beta antibody treatments, which have shown symptomatic benefit in Alzheimer's.
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NewsEarly allogeneic cell therapy trial results offer hope for sight condition
Based on positive outcomes of the clinical trial, a high dose of the cell therapy is expected to advance to Phase III pivotal trials.
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ArticleAdopting AI for R&D in 2025 – what needs to be addressed?
Dr Vladimir Makarov, AI Community lead, The Pistoia Alliance, explains that despite the willingness of the life sciences R&D industry to adopt artificial intelligence (AI), data integrity is a key area that must be addressed to ensure successful integration of this fast-evolving technology.
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NewsAntibody drug has promise as “next frontier” in inflammatory bowel disease
With its best-in-class potential, the biologic could provide a new treatment option for patients with inflammatory bowel disease (IBD), say Teva Pharmaceuticals and Sanofi.
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WebinarTrends for life sciences quality leaders in 2025 - mastering what matters
This webinar explores the major trends impacting life sciences in 2025 and how the pharma industry can capitalise on the latest developments shaping quality management.
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NewsCHMP recommends novel long-acting HIV treatment
The positive opinion means HIV patients could overcome challenges of taking daily oral regimens, says ViiV Healthcare's Chief Medical Officer.
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ArticleTargeting ovarian cancer with a novel antibody therapeutic
Christina Pelizon, International Medical Affairs Head for Oncology at AbbVie discusses the significance and impact of the European Commission’s approval last month of Elahere® (mirvetuximab soravtansine) to treat ovarian cancer.
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NewsASH 2024: CAR T-cell therapy demonstrates durable benefit in lymphoma
The cell therapy could increase survival in certain lymphomas without requiring patients to undertake subsequent therapy, the new analysis suggests.
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WhitepaperNSF’s quality management maturity (QMM) assessment model
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
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News£16 million to fund UK-Switzerland life sciences research
The joint agreement between two key global players in life sciences, the UK and Switzerland, marks a long-term commitment to strengthening research in the sector.
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WebinarNavigating pharmaceutical environmental monitoring in a changing industry
During this virtual panel, industry experts explore the latest advances in environmental monitoring, discuss key challenges within the sector and approaches that can prevent and mitigate these issues.
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NewsEarly promise for novel breast cancer immunotherapy
With potential “groundbreaking” results, the immunotherapy could alter the need for breast cancer patients to undertake chemotherapy, trial investigators suggest.
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NewsEli Lilly collaboration to accelerate biotech manufacturing
The partnership will provide biotech companies with accelerated access to clinical development capabilities, including drug development and analytical services.
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ArticleInvesting in the future of pharmaceutical microbiology QC
Troy Wright, Senior Vice President and Global Head of Quality at Abzena, shares an overview of current major challenges within pharmaceutical microbiology quality control, including the lack of staff knowledge in advanced technologies and how the sector’s importance can be overlooked, despite its key role in bringing safe, quality products ...
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NewsNovartis to advance novel Huntington's disease therapy
As part of the agreement with Novartis Pharmaceuticals, PTC will receive an initial $1 billion to develop the potential first-in-class oral therapy.
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NewsNew mass spectrometry Chapter could “revolutionise” biopharma quality assurance
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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ReportPharma Horizons: Sustainability
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key sustainability developments in the pharmaceutical industry and covers topics including regulation, manufacturing and clinical development.
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ArticleThe EU AI Act: will regulation drive life science innovation away from Europe?
Mike King, Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), Digital Products & Solutions at IQVIA and Alex Denoon, Partner at Bristows Law Firm, explore the challenges of implementing the EU AI Act and the impact of GDPR requirements in life sciences.
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NewsStudy proposes system to produce endotoxin-free recombinant proteins
The system is distinguishable from other bacterial expression systems and can be applied in scenarios where minimal endotoxin contamination is an issue, according to the research.