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Benchmarking R&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006-2022). 领先制药公司研发成功率标杆化：2006-2022年FDA批准的实证分析。
IF 6.5 2区 医学
Drug Discovery Today Pub Date : 2025-01-11 DOI: 10.1016/j.drudis.2025.104291
Alexander Schuhmacher, Markus Hinder, Elazar Brief, Oliver Gassmann, Dominik Hartl
{"title":"Benchmarking R&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006-2022).","authors":"Alexander Schuhmacher, Markus Hinder, Elazar Brief, Oliver Gassmann, Dominik Hartl","doi":"10.1016/j.drudis.2025.104291","DOIUrl":"10.1016/j.drudis.2025.104291","url":null,"abstract":"<p><p>Previous analyses provide an industry benchmark of ∼10% for the success rate in clinical development. However, prior analyses were limited by a narrow timeframe, a diverse research focus, biases in phase-to-phase transition methodology or a focus on specific use cases. We calculated unbiased input:output ratios (Phase I to FDA new drug approval) to analyze the likelihood of first approval using data from clinicaltrials.gov, encompassing a total of 2092 active ingredients, 19 927 clinical trials conducted by 18 leading pharmaceutical companies (2006-2022) and 274 new drug approvals. Our study reveals an average likelihood of first approval rate of 14.3% across leading research-based pharmaceutical companies, broadly ranging from 8% to 23%.</p>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":" ","pages":"104291"},"PeriodicalIF":6.5,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142976919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nanozyme-based synergistic therapeutic strategies against tumors. 基于纳米酶的肿瘤协同治疗策略。
IF 6.5 2区 医学
Drug Discovery Today Pub Date : 2025-01-11 DOI: 10.1016/j.drudis.2025.104292
Ye Zhang, Ning Zhang, Shou-Ping Gong, Zhe-Sheng Chen, Hui-Ling Cao
{"title":"Nanozyme-based synergistic therapeutic strategies against tumors.","authors":"Ye Zhang, Ning Zhang, Shou-Ping Gong, Zhe-Sheng Chen, Hui-Ling Cao","doi":"10.1016/j.drudis.2025.104292","DOIUrl":"10.1016/j.drudis.2025.104292","url":null,"abstract":"<p><p>Cancer remains a global health threat, with traditional treatments limited by adverse effects and drug resistance. Nanozyme-based catalytic therapy with high stability and controllable activity provides targeted and specific in situ tumor treatment to address these challenges. More intriguingly, the tremendous advances in nanotechnology have enabled nanozymes to rival the catalytic activity of natural enzymes, presenting an exciting opportunity for innovating antitumor nanodrugs. This review systematically summarizes the latest progresses in nanozyme-based anticancer catalytic therapy, with a particular focus on various synergistic antitumor strategies, including other functional enzymes, drugs, exogenous stimuli and radiotherapy. These combinations not only enhance the efficacy of cancer treatment and reduce systemic toxicity but also offer insights into the development of potent antitumor nanodrugs.</p>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":" ","pages":"104292"},"PeriodicalIF":6.5,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142976925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Molecular biomarkers of glial activation and injury in epilepsy. 癫痫中神经胶质活化和损伤的分子生物标志物。
IF 6.5 2区 医学
Drug Discovery Today Pub Date : 2025-01-10 DOI: 10.1016/j.drudis.2025.104289
Reema A Kalsariya, Dave Kavila, Susan Shorter, Deepika Negi, Iain C A Goodall, Stergios Boussios, Saak V Ovsepian
{"title":"Molecular biomarkers of glial activation and injury in epilepsy.","authors":"Reema A Kalsariya, Dave Kavila, Susan Shorter, Deepika Negi, Iain C A Goodall, Stergios Boussios, Saak V Ovsepian","doi":"10.1016/j.drudis.2025.104289","DOIUrl":"10.1016/j.drudis.2025.104289","url":null,"abstract":"<p><p>Increasing evidence from fluid biopsies suggests activation and injury of glial cells in epilepsy. The prevalence of clinical and subclinical seizures in neurodegenerative conditions such as Alzheimer's disease, frontotemporal dementia, and others merits review and comparison of the effects of seizures on glial markers in epilepsy and neurodegenerative diseases with concomitant seizures. Herein, we revisit preclinical and clinical reports of alterations in glial proteins in cerebrospinal fluid and blood associated with various types of epilepsy. We consider shared and distinct characteristics of changes in different age groups and sexes, in humans and animal models of epilepsy, and compare them with those reported in biofluids in neurodegenerative diseases. Our analysis indicates a significant overlap of glial response in these prevalent neurological conditions.</p>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":" ","pages":"104289"},"PeriodicalIF":6.5,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142968920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Multi-layer platform coordination for open innovation in oligonucleotide therapeutics. 寡核苷酸疗法开放式创新的多层平台协同。
IF 6.5 2区 医学
Drug Discovery Today Pub Date : 2025-01-09 DOI: 10.1016/j.drudis.2025.104288
Yayoi Kawata, Taisuke Ichimaru, Masakazu Kogami, Kota Kodama, Shuto Miyashita, Shintaro Sengoku
{"title":"Multi-layer platform coordination for open innovation in oligonucleotide therapeutics.","authors":"Yayoi Kawata, Taisuke Ichimaru, Masakazu Kogami, Kota Kodama, Shuto Miyashita, Shintaro Sengoku","doi":"10.1016/j.drudis.2025.104288","DOIUrl":"10.1016/j.drudis.2025.104288","url":null,"abstract":"<p><p>As technology evolves and medical needs diversify, the pharmaceutical industry must accelerate its openness. This study analysed inter-organizational alliances in R&D for the new modality of oligonucleotide therapeutics to explore the requirements for establishing new markets. The results confirmed that the market has developed in stages, employing open innovation for different purposes according to technological progress. At each stage, it was crucial to form platforms among biotech companies on the drug discovery side, among pharmaceutical companies on the regulatory side and contract development manufacturing organizations (CDMOs) on the manufacturing side. These findings clarify the dynamics of open innovation in the biopharmaceutical industry and provide strategic implications for sustainable value creation in drug R&D.</p>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":" ","pages":"104288"},"PeriodicalIF":6.5,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142963408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Repairing muscle with broccoli-derived sulforaphane: A preclinical evaluation for the treatment of mitochondrial myopathies. 用西兰花提取的莱菔硫烷修复肌肉：治疗线粒体肌病的临床前评估。
IF 6.5 2区 医学
Drug Discovery Today Pub Date : 2025-01-01 Epub Date: 2024-12-28 DOI: 10.1016/j.drudis.2024.104283
Thomas Lilley, Donny M Camera, Faith A A Kwa
{"title":"Repairing muscle with broccoli-derived sulforaphane: A preclinical evaluation for the treatment of mitochondrial myopathies.","authors":"Thomas Lilley, Donny M Camera, Faith A A Kwa","doi":"10.1016/j.drudis.2024.104283","DOIUrl":"10.1016/j.drudis.2024.104283","url":null,"abstract":"<p><p>Skeletal muscle health relies on the production of adenosine triphosphate (ATP) in the mitochondria. ATP production is accompanied by oxidative phosphorylation, which generates reactive oxygen species (ROS). When there is an imbalance in ROS levels, oxidative stress and subsequent mitochondrial dysfunction, mitochondrial myopathies including sarcopenia, chronic progressive external ophthalmoplegia, and proximal myopathy can result. Such incurable myopathies are characterised by aberrant metabolism, limited ATP production, and muscle atrophy. Broccoli-derived sulforaphane has emerged as a novel treatment for mitochondrial myopathies because of its antioxidant and anti-inflammatory properties. This review discusses preclinical studies that reveal sulforaphane's potential therapeutic benefits and limitations in treating mitochondrial myopathies.</p>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":" ","pages":"104283"},"PeriodicalIF":6.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142906437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Stimulating development of innovative medicines in the European Union: does a new definition for unmet medical need add value? 刺激欧盟创新药物的发展：未满足医疗需求的新定义是否会增加价值？
IF 6.5 2区 医学
Drug Discovery Today Pub Date : 2025-01-01 Epub Date: 2024-11-26 DOI: 10.1016/j.drudis.2024.104251
Lourens T Bloem, Hubert G M Leufkens, Sophie E Berends, Rick A Vreman, Carla E M Hollak, Sonja van Weely, Larissa M de Lannoy, Peter J A Bertens, Anna M G Pasmooij
{"title":"Stimulating development of innovative medicines in the European Union: does a new definition for unmet medical need add value?","authors":"Lourens T Bloem, Hubert G M Leufkens, Sophie E Berends, Rick A Vreman, Carla E M Hollak, Sonja van Weely, Larissa M de Lannoy, Peter J A Bertens, Anna M G Pasmooij","doi":"10.1016/j.drudis.2024.104251","DOIUrl":"10.1016/j.drudis.2024.104251","url":null,"abstract":"<p><p>The European Commission (EC) has proposed to redefine 'unmet medical need' to steer pharmaceutical innovation and link the definition to incentives and regulatory tools and procedures. A multistakeholder meeting of the Regulatory Science Network Netherlands (RSNN) discussed the impact of this proposal. Four principles were highlighted (flexibility, feasibility, fairness, and sensitivity to risk) that were not considered sufficiently addressed. Concerns were raised about whether innovation would be incentivised, given the diverse and complex reasons why areas of unmet medical need may remain unaddressed. A more high-level definition of unmet medical need that gives guidance but allows for specification for specific uses throughout the medicine lifecycle was generally preferred. As the legislative process unfolds, stakeholder engagement will be essential to refine the definition to achieve the intended policy goals.</p>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":" ","pages":"104251"},"PeriodicalIF":6.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Revising EU pharmaceutical legislation: will it foster drug repurposing? 修订欧盟药品立法：会促进药品再利用吗？
IF 6.5 2区 医学
Drug Discovery Today Pub Date : 2025-01-01 Epub Date: 2025-01-03 DOI: 10.1016/j.drudis.2024.104286
Mirre Scholte, Sabine E Grimm, Bianca Pauly, Frank Verbeeck, Anna M G Pasmooij, Barend Bouma, Jorika van Duijn-Wiersma, Emre Guney, Aaron S Kesselheim, Harald H H W Schmidt, Manuela A Joore
{"title":"Revising EU pharmaceutical legislation: will it foster drug repurposing?","authors":"Mirre Scholte, Sabine E Grimm, Bianca Pauly, Frank Verbeeck, Anna M G Pasmooij, Barend Bouma, Jorika van Duijn-Wiersma, Emre Guney, Aaron S Kesselheim, Harald H H W Schmidt, Manuela A Joore","doi":"10.1016/j.drudis.2024.104286","DOIUrl":"10.1016/j.drudis.2024.104286","url":null,"abstract":"<p><p>Repurposing off-patent drugs can be a potential source of low-cost treatments for patients with unmet medical needs. Here, we review the proposed new European Union (EU) pharmaceutical legislation in which two articles address drug repurposing. We find certain barriers hindering the adoption of these new incentives by academic and not-for-profit stakeholders, including lack of knowledge on regulatory aspects, pharmacovigilance, and restrictions in data protection. To further empower the intended stakeholders of the legislation, these initiatives can be strengthened by creating additional scientific, regulatory, and health technology assessment (HTA) support for not-for-profit repurposers, and by determining fair data protection periods and pricing policies. To support drug repurposing, Europe should work toward a comprehensive drug-repurposing strategy that fosters the repurposing of generic, shelved, and protected drugs.</p>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":" ","pages":"104286"},"PeriodicalIF":6.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930010","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Generative AI: driving productivity and scientific breakthroughs in pharmaceutical R&D. 生成式人工智能：推动制药研发的生产力和科学突破。
IF 6.5 2区 医学
Drug Discovery Today Pub Date : 2025-01-01 Epub Date: 2024-12-13 DOI: 10.1016/j.drudis.2024.104272
Guy Doron, Sam Genway, Mark Roberts, Sai Jasti
{"title":"Generative AI: driving productivity and scientific breakthroughs in pharmaceutical R&D.","authors":"Guy Doron, Sam Genway, Mark Roberts, Sai Jasti","doi":"10.1016/j.drudis.2024.104272","DOIUrl":"10.1016/j.drudis.2024.104272","url":null,"abstract":"<p><p>The rapid advancement of generative artificial intelligence (AI) is reshaping pharmaceutical research and development (R&D), offering opportunities across drug discovery and development. Generative AI (GenAI) enhances productivity by enabling virtual assistants, which help automate routine tasks. It advances novel small-molecule drug design and drives new machine learning (ML) applications through synthetic data generation. Further impact is anticipated in drug development from improving operational efficiencies to novel digital innovations. Converging technologies enable rich data set capture, and next-generation AI will enable rapid, automated hypothesis generation and testing. Here, we assess the current and future applications, and the mid-term and long-term transformative potential, of GenAI in pharmaceutical R&D.</p>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":" ","pages":"104272"},"PeriodicalIF":6.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142826896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Magnetic microscale polymeric nanocomposites in drug delivery: advances and challenges. 磁性微尺度聚合物纳米复合材料在给药中的应用：进展与挑战。
IF 6.5 2区 医学
Drug Discovery Today Pub Date : 2025-01-01 Epub Date: 2024-12-29 DOI: 10.1016/j.drudis.2024.104276
Kejing Shi, Ali Nokhodchi, Taravat Ghafourian
{"title":"Magnetic microscale polymeric nanocomposites in drug delivery: advances and challenges.","authors":"Kejing Shi, Ali Nokhodchi, Taravat Ghafourian","doi":"10.1016/j.drudis.2024.104276","DOIUrl":"10.1016/j.drudis.2024.104276","url":null,"abstract":"<p><p>Magnetic polymeric nanocomposites are a modern class of materials in which magnetic nanoparticles are embedded in a polymeric matrix. This combination of magnetic responsiveness and tuneable properties bestows versatility on this class of polymer nanocomposite material, which has potentially broad applications in drug delivery, imaging, environmental remediation and beyond. This review covers the uses of magnetic polymeric nanocomposites in drug delivery, discussing magnetic micelles, magnetic liposomes, magnetic hydrogels, magnetic sponges, magnetic mesoporous silica nanoparticles, magnetic microrobots, magnetic elastomers and magnetic scaffolds. The focus is on the role that might be played by magnetic nanocomposites as an interface between the magnetic and polymeric domains in the establishment of a new generation of advanced materials.</p>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":" ","pages":"104276"},"PeriodicalIF":6.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142906435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Targeting spleen tyrosine kinase (SYK): structure, mechanisms and drug discovery. 靶向脾酪氨酸激酶（SYK）：结构、机制和药物发现。
IF 6.5 2区 医学
Drug Discovery Today Pub Date : 2025-01-01 Epub Date: 2024-12-07 DOI: 10.1016/j.drudis.2024.104257
Shuangqian Zhang, Lilin Wang, Yingying Lu, Chuanxin Guo, Tongtong Zhang, Lan Zhang
{"title":"Targeting spleen tyrosine kinase (SYK): structure, mechanisms and drug discovery.","authors":"Shuangqian Zhang, Lilin Wang, Yingying Lu, Chuanxin Guo, Tongtong Zhang, Lan Zhang","doi":"10.1016/j.drudis.2024.104257","DOIUrl":"10.1016/j.drudis.2024.104257","url":null,"abstract":"<p><p>Spleen tyrosine kinase (SYK) is a crucial non-receptor tyrosine kinase involved in signaling pathways that regulate various cellular processes. It is primarily expressed in hematopoietic cells and myeloid cells, which are crucial for B-cell development, maturation and antibody production, and it is a key therapeutic target for autoimmune and allergic diseases. Overexpression of SYK is also associated with cancer and cardiovascular, cerebrovascular and neurodegenerative diseases, contributing to their initiation and progression. SYK is a promising target for drug development, and several inhibitors have already been reported. This review covers the structure and regulatory pathways of SYK, as well as its links to various diseases. It also highlights key small-molecule SYK inhibitors, their design strategies and their potential therapeutic benefits, aiming to enhance our understanding and aid in the discovery of more-effective SYK inhibitors.</p>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":" ","pages":"104257"},"PeriodicalIF":6.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142798909","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","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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