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FDA pushes to replace animal testing FDA推动替代动物试验
IF 46.9 1区 生物学
Nature biotechnology Pub Date : 2025-05-16 DOI: 10.1038/s41587-025-02690-0
{"title":"FDA pushes to replace animal testing","authors":"","doi":"10.1038/s41587-025-02690-0","DOIUrl":"https://doi.org/10.1038/s41587-025-02690-0","url":null,"abstract":"<p>The US Food and Drug Administration plans to introduce computational modeling and other innovative methods to replace animal testing in preclinical drug safety studies, according to a roadmap released in April. By encouraging drug sponsors to embrace organ-on-a chip, in silico modeling, organoid and other in vitro assays, the FDA aims to reduce animal testing to the extent that it becomes “the exception rather than the norm” within 3–5 years. The FDA’s roadmap builds on the 2022 FDA Modernization Act 2.0, passed by Congress, which removed the requirement for animal testing in biosimilar biologics’ applications.</p>","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"218 1","pages":""},"PeriodicalIF":46.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144066965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Biotech news from around the world 来自世界各地的生物技术新闻
IF 46.9 1区 生物学
Nature biotechnology Pub Date : 2025-05-16 DOI: 10.1038/s41587-025-02680-2
{"title":"Biotech news from around the world","authors":"","doi":"10.1038/s41587-025-02680-2","DOIUrl":"https://doi.org/10.1038/s41587-025-02680-2","url":null,"abstract":"<p>As part of its Dare2eraD TB initiative to combat the challenge of drug-resistant tuberculosis, Indian researchers sequence the genomes of 10,000 <i>Mycobacterium tuberculosis</i> isolates. Sequencing will aid in personalizing antibiotic prescription, allowing faster, more effective treatment. India has set the goal of eliminating TB by 2025, five years ahead of the World Health Organization’s global target.</p>","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"6 1","pages":""},"PeriodicalIF":46.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144066964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Author Correction: Efficient C-to-T base editing in plants using a fusion of nCas9 and human APOBEC3A 作者更正：利用nCas9和人类APOBEC3A的融合在植物中进行高效的C-to-T碱基编辑
IF 46.9 1区 生物学
Nature biotechnology Pub Date : 2025-05-16 DOI: 10.1038/s41587-025-02676-y
Yuan Zong, Qianna Song, Chao Li, Shuai Jin, Dingbo Zhang, Yanpeng Wang, Jin-Long Qiu, Caixia Gao
{"title":"Author Correction: Efficient C-to-T base editing in plants using a fusion of nCas9 and human APOBEC3A","authors":"Yuan Zong, Qianna Song, Chao Li, Shuai Jin, Dingbo Zhang, Yanpeng Wang, Jin-Long Qiu, Caixia Gao","doi":"10.1038/s41587-025-02676-y","DOIUrl":"https://doi.org/10.1038/s41587-025-02676-y","url":null,"abstract":"<p>Correction to: <i>Nature Biotechnology</i> https://doi.org/10.1038/nbt.4261, published online 1 October 2018.</p>","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"56 1","pages":""},"PeriodicalIF":46.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144067050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Consternation follows Marks’ FDA departure 马克斯离开FDA后，人们感到惊愕
IF 46.9 1区 生物学
Nature biotechnology Pub Date : 2025-05-16 DOI: 10.1038/s41587-025-02689-7
{"title":"Consternation follows Marks’ FDA departure","authors":"","doi":"10.1038/s41587-025-02689-7","DOIUrl":"https://doi.org/10.1038/s41587-025-02689-7","url":null,"abstract":"<p>In late March, the US Food and Drug Administration’s (FDA) director of the Center for Biologics Evaluation and Research, Peter Marks, resigned under pressure from Health and Human Services Secretary Robert F. Kennedy. In his resignation letter Marks said he had been asked to hand in data on measles vaccine-related deaths and brain swelling that do not exist.</p>","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"29 1","pages":""},"PeriodicalIF":46.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144066935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bioprinting 生物打印
IF 46.9 1区 生物学
Nature biotechnology Pub Date : 2025-05-16 DOI: 10.1038/s41587-025-02662-4
{"title":"Bioprinting","authors":"","doi":"10.1038/s41587-025-02662-4","DOIUrl":"https://doi.org/10.1038/s41587-025-02662-4","url":null,"abstract":"Recent patents relating to systems, methods and compositions for bioprinting.","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"74 1","pages":""},"PeriodicalIF":46.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144066967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Biotech Explorers Pathway equips students for STEM futures 生物技术探索者路径为学生的STEM未来做好准备
IF 46.9 1区 生物学
Nature biotechnology Pub Date : 2025-05-16 DOI: 10.1038/s41587-025-02666-0
Anne E. Robinson, Barrie Cascella, Marta M. Wegorzewska, Daniel A. Berkovich, Joseph M. Jez
{"title":"The Biotech Explorers Pathway equips students for STEM futures","authors":"Anne E. Robinson, Barrie Cascella, Marta M. Wegorzewska, Daniel A. Berkovich, Joseph M. Jez","doi":"10.1038/s41587-025-02666-0","DOIUrl":"https://doi.org/10.1038/s41587-025-02666-0","url":null,"abstract":"Building undergraduate courses around biotechnology ventures integrates real-world science, business, career preparation and creative thinking for STEM student preparation.","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"14 1","pages":""},"PeriodicalIF":46.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144067053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Biopharma dives into tumor-seeking radioactive drugs 生物制药研究寻找肿瘤的放射性药物
IF 46.9 1区 生物学
Nature biotechnology Pub Date : 2025-05-16 DOI: 10.1038/s41587-025-02681-1
{"title":"Biopharma dives into tumor-seeking radioactive drugs","authors":"","doi":"10.1038/s41587-025-02681-1","DOIUrl":"https://doi.org/10.1038/s41587-025-02681-1","url":null,"abstract":"Big pharma and investors are piling into the precision radiation space as the next generation of increasingly potent targeted α-particle therapies promises to destroy cancerous cells with minimum damage to healthy tissues.","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"30 1","pages":""},"PeriodicalIF":46.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144067054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Engineering non-viral protein nanoparticles to deliver nucleic acids and proteins to cells 设计非病毒蛋白质纳米颗粒，将核酸和蛋白质输送到细胞
IF 46.9 1区 生物学
Nature biotechnology Pub Date : 2025-05-16 DOI: 10.1038/s41587-025-02665-1
{"title":"Engineering non-viral protein nanoparticles to deliver nucleic acids and proteins to cells","authors":"","doi":"10.1038/s41587-025-02665-1","DOIUrl":"https://doi.org/10.1038/s41587-025-02665-1","url":null,"abstract":"Protein materials are promising drug delivery vehicles, but their use for intracellular protein and nucleic acid cargo delivery has been limited. We have developed self-assembling elastin-like polypeptide (ELP)-based protein nanoparticles that are functionalized to enable complexation and intracellular delivery of biomacromolecular cargo, including gene editors in the form of mRNA, plasmid DNA and ribonucleoproteins.","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"51 1","pages":""},"PeriodicalIF":46.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144066958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reprogramming endogenous regulatory DNA to fine-tune gene expression 重新编程内源性调控DNA以微调基因表达
IF 46.9 1区 生物学
Nature biotechnology Pub Date : 2025-05-16 DOI: 10.1038/s41587-025-02686-w
Iris Marchal
{"title":"Reprogramming endogenous regulatory DNA to fine-tune gene expression","authors":"Iris Marchal","doi":"10.1038/s41587-025-02686-w","DOIUrl":"https://doi.org/10.1038/s41587-025-02686-w","url":null,"abstract":"<p>Regulatory DNA sequences orchestrate cell-type-specific gene expression by facilitating transcription factor binding, yet their precise effects and reprogrammability remain challenging to delineate. Now, in <i>Cell</i>, Martyn et al. develop a method called variant effects from flow-sorting experiments with CRISPR targeting screens (Variant-EFFECTS), which measures the quantitative effects of changes to regulatory DNA on gene expression in endogenous contexts without the need for genetic engineering of reporters.</p><p>Variant-EFFECTS uses pooled prime editing to introduce hundreds of noncoding edits to regulatory sequences in cells. The cells are then labeled with RNA FlowFISH or a fluorescent antibody targeted to a gene of interest, and sorted on the basis of levels of fluorescence. To demonstrate the usefulness of the method, the authors performed tiling mutagenesis screens targeting the promotor and/or enhancer regions for two genes involved in immune responses (<i>PPIF</i> and <i>IL2RA</i>) in THP-1 cells and Jurkat T cells. This revealed several motif instances with strong effects on gene-expression levels, including some missed by massively parallel reporter assays. Variant-EFFECTS can also dissect the context-specific effects of transcription factor motifs by inserting them across cell types. Moreover, the authors used Variant-EFFECTS data to benchmark deep-learning models that predict gene regulatory signals directly from DNA sequence, which revealed limitations to these models for predicting effect sizes of variants.</p>","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"27 1","pages":""},"PeriodicalIF":46.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144067052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
People 人
IF 46.9 1区 生物学
Nature biotechnology Pub Date : 2025-05-16 DOI: 10.1038/s41587-025-02670-4
{"title":"People","authors":"","doi":"10.1038/s41587-025-02670-4","DOIUrl":"https://doi.org/10.1038/s41587-025-02670-4","url":null,"abstract":"Recent moves of note in and around the biotech and pharma industries.","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"11 1","pages":""},"PeriodicalIF":46.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144066957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","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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