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Generative AI: a generation-defining shift for biopharma regulatory affairs 生成式人工智能：生物制药监管事务的一代定义转变
Nature Reviews Drug Discovery Pub Date : 2025-06-25 DOI: 10.1038/d41573-025-00089-9
Jon Williams, Donna Boyce, Graziella Collu, Sean Curtis, Ramzi Dagher, Peter Gamble, Magdalena Jayatissa, Eugene Leypunskiy, Sabine Luik, Beatriz Monedero Alvarez, Trine Birgitte Moulvad, Meena Murugappan, Alexandra Pearce, Eddie Reilly, Piero Rijli, Ruben Rizzi, Katrin Rupalla, Punam Sandhu, Thomas Seck, Michael Søberg Christensen, Mark Taisey, Cyril Widmaier, Myrto Lee
{"title":"Generative AI: a generation-defining shift for biopharma regulatory affairs","authors":"Jon Williams, Donna Boyce, Graziella Collu, Sean Curtis, Ramzi Dagher, Peter Gamble, Magdalena Jayatissa, Eugene Leypunskiy, Sabine Luik, Beatriz Monedero Alvarez, Trine Birgitte Moulvad, Meena Murugappan, Alexandra Pearce, Eddie Reilly, Piero Rijli, Ruben Rizzi, Katrin Rupalla, Punam Sandhu, Thomas Seck, Michael Søberg Christensen, Mark Taisey, Cyril Widmaier, Myrto Lee","doi":"10.1038/d41573-025-00089-9","DOIUrl":"https://doi.org/10.1038/d41573-025-00089-9","url":null,"abstract":"As biopharmaceutical companies face mounting pressure to accelerate development timelines and improve the speed and quality of regulatory submissions, many are actively exploring the potential of generative artificial intelligence (GenAI) to transform how regulatory work gets done. This article examines how leading organizations are beginning to apply GenAI to automate content creation, analyse complex data, and streamline core regulatory activities — and the critical success factors for driving adoption at scale.","PeriodicalId":18847,"journal":{"name":"Nature Reviews Drug Discovery","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144479116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mosquito-targeted malaria control 以蚊子为目标的疟疾控制
Nature Reviews Drug Discovery Pub Date : 2025-06-24 DOI: 10.1038/d41573-025-00111-0
{"title":"Mosquito-targeted malaria control","authors":"","doi":"10.1038/d41573-025-00111-0","DOIUrl":"https://doi.org/10.1038/d41573-025-00111-0","url":null,"abstract":"Discover the world’s best science and medicine | Nature.com","PeriodicalId":18847,"journal":{"name":"Nature Reviews Drug Discovery","volume":"242 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144370490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Inhibiting myosin in glioblastoma 胶质母细胞瘤中肌球蛋白的抑制作用
Nature Reviews Drug Discovery Pub Date : 2025-06-24 DOI: 10.1038/d41573-025-00113-y
{"title":"Inhibiting myosin in glioblastoma","authors":"","doi":"10.1038/d41573-025-00113-y","DOIUrl":"https://doi.org/10.1038/d41573-025-00113-y","url":null,"abstract":"Discover the world’s best science and medicine | Nature.com","PeriodicalId":18847,"journal":{"name":"Nature Reviews Drug Discovery","volume":"51 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144370489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Base editing tackles trinucleotide repeat diseases 碱基编辑处理三核苷酸重复疾病
Nature Reviews Drug Discovery Pub Date : 2025-06-24 DOI: 10.1038/d41573-025-00110-1
{"title":"Base editing tackles trinucleotide repeat diseases","authors":"","doi":"10.1038/d41573-025-00110-1","DOIUrl":"https://doi.org/10.1038/d41573-025-00110-1","url":null,"abstract":"Discover the world’s best science and medicine | Nature.com","PeriodicalId":18847,"journal":{"name":"Nature Reviews Drug Discovery","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144370488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Understanding semaglutide action in the brain 了解semaglutide在大脑中的作用
Nature Reviews Drug Discovery Pub Date : 2025-06-24 DOI: 10.1038/d41573-025-00112-z
{"title":"Understanding semaglutide action in the brain","authors":"","doi":"10.1038/d41573-025-00112-z","DOIUrl":"https://doi.org/10.1038/d41573-025-00112-z","url":null,"abstract":"Discover the world’s best science and medicine | Nature.com","PeriodicalId":18847,"journal":{"name":"Nature Reviews Drug Discovery","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144370487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Neurotensin receptor modulator safely tackles pain 神经紧张素受体调节剂安全处理疼痛
Nature Reviews Drug Discovery Pub Date : 2025-06-20 DOI: 10.1038/d41573-025-00109-8
{"title":"Neurotensin receptor modulator safely tackles pain","authors":"","doi":"10.1038/d41573-025-00109-8","DOIUrl":"https://doi.org/10.1038/d41573-025-00109-8","url":null,"abstract":"Discover the world’s best science and medicine | Nature.com","PeriodicalId":18847,"journal":{"name":"Nature Reviews Drug Discovery","volume":"606 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144328927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Neutrophil-targeting drug seeks first approval in an inflammatory lung disease 中性粒细胞靶向药物寻求首次批准用于炎症性肺病
Nature Reviews Drug Discovery Pub Date : 2025-06-17 DOI: 10.1038/d41573-025-00108-9
{"title":"Neutrophil-targeting drug seeks first approval in an inflammatory lung disease","authors":"","doi":"10.1038/d41573-025-00108-9","DOIUrl":"https://doi.org/10.1038/d41573-025-00108-9","url":null,"abstract":"Insmed’s DPP1 inhibitor brensocatib could become the first drug to secure an approval for bronchiectasis, and is in trials for other inflammatory diseases.","PeriodicalId":18847,"journal":{"name":"Nature Reviews Drug Discovery","volume":"178 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144304667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Upcoming FDA approval decisions in Q3 2025 FDA将于2025年第三季度做出批准决定
Nature Reviews Drug Discovery Pub Date : 2025-06-16 DOI: 10.1038/d41573-025-00103-0
{"title":"Upcoming FDA approval decisions in Q3 2025","authors":"","doi":"10.1038/d41573-025-00103-0","DOIUrl":"https://doi.org/10.1038/d41573-025-00103-0","url":null,"abstract":"Discover the world’s best science and medicine | Nature.com","PeriodicalId":18847,"journal":{"name":"Nature Reviews Drug Discovery","volume":"91 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144296006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Keeping the immuno-oncology flame burning 让免疫肿瘤学的火焰继续燃烧
Nature Reviews Drug Discovery Pub Date : 2025-06-13 DOI: 10.1038/d41573-025-00107-w
{"title":"Keeping the immuno-oncology flame burning","authors":"","doi":"10.1038/d41573-025-00107-w","DOIUrl":"https://doi.org/10.1038/d41573-025-00107-w","url":null,"abstract":"Ira Mellman, the new president of research at the Parker Institute for Cancer Immunotherapy, asks why so many drug developers are retreating from immune-modulating drugs, cell therapies and cancer vaccines before these modalities have achieved their full potential.","PeriodicalId":18847,"journal":{"name":"Nature Reviews Drug Discovery","volume":"64 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144278783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Targeting DNA damage in ageing: towards supercharging DNA repair 针对衰老过程中的DNA损伤：迈向加速DNA修复
Nature Reviews Drug Discovery Pub Date : 2025-06-12 DOI: 10.1038/s41573-025-01212-6
Arturo Bujarrabal-Dueso, George A. Garinis, Paul D. Robbins, Jan Vijg, Björn Schumacher
{"title":"Targeting DNA damage in ageing: towards supercharging DNA repair","authors":"Arturo Bujarrabal-Dueso, George A. Garinis, Paul D. Robbins, Jan Vijg, Björn Schumacher","doi":"10.1038/s41573-025-01212-6","DOIUrl":"https://doi.org/10.1038/s41573-025-01212-6","url":null,"abstract":"<p>Ageing is the most important risk factor for many common human diseases, including cancer, diabetes, neurodegeneration and cardiovascular disease. Consequently, combating ageing itself has emerged as a rational strategy for addressing age-related multimorbidity. Over the past three decades, multiple genetic and pharmacologic interventions have led to substantial extension of lifespan and healthspan in model organisms. However, it is unclear whether these interventions target the causal mechanisms of ageing or downstream consequences. Ample evidence suggests that DNA damage to the somatic genome is a major causal mechanism of ageing, which compromises essential cellular functions such as transcription and replication, and leads to cellular senescence, apoptosis and mutations. Recently, new concepts have emerged to target the main consequences of DNA damage and enhance DNA repair capacities, thereby extending maintenance of the genome. Here, we review advances in this field and discuss approaches to pharmacologically mitigate the adverse effects of DNA damage to delay ageing, prevent mutation-driven cancer and mitigate age-related degenerative diseases.</p>","PeriodicalId":18847,"journal":{"name":"Nature Reviews Drug Discovery","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144278784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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