元界

欧洲药品管理局（EMA）紧急任务小组（ETF）与非洲药品管理局（AMA）发布了一份联合立场文件，以支持潜在……的临床试验及时启动

EMA’s Emergency Task Force (ETF) and the African Medicines Agency (AMA) have published a joint position paper to support the timely start of clinical trials for potential…

六种新药获推荐批准 欧洲药品管理局（EMA）的人用药品委员会（CHMP）在其2026年10月会议上推荐批准六种药物。Rasonque（daraxonrasib）…，CHMP统计 2026年10月CHMP会议的关键数据展示于下图。© 欧洲药品管理局，CHMP统计：…，对新药的肯定性推荐，Foundayo 国际非专利名称（INN）orforglipron 上市许可申请人 Eli Lilly Nederland B.V. 治疗适应证 …的治疗，Rasonque INN daraxonrasib 上市许可申请人 Revolution Medicines Netherlands B.V. 治疗适应证 转移性胰腺…的治疗，Yuviwel INN navepegritide 上市许可申请人 Ascendis Pharma Growth Disorders A/S 治疗适应证

Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting.Rasonque (daraxonrasib)…, CHMP statistics Key figures from the October 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive recommendations on new medicines, Foundayo International non-proprietary name (INN) orforglipron Marketing authorisation applicant Eli Lilly Nederland B.V. Therapeutic indication Treatment of…, Rasonque INN daraxonrasib Marketing authorisation applicant Revolution Medicines Netherlands B.V. Therapeutic indication Treatment of metastatic pancreatic…, Yuviwel INN navepegritide Marketing authorisation applicant Ascendis Pharma Growth Disorders A/S Therapeutic indica

欧洲药品管理局的人用医药产品委员会（CHMP）已建议授予Rasonque（daraxonrasib）在欧盟的上市许可，该药是一种口服治疗药物，用于患有……的成人患者。

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Rasonque (daraxonrasib), an oral treatment for adults with…

今天，作为其加强卫生信息系统和改善健康[1]承诺的一部分，尤其是在COVID-19大流行的背景下，世界卫生组织宣布了一项改善救生数据可及性的新方法：SCORE卫生数据技术包。COVID-19大流行突显了及时可靠的数据对推动战略卫生行动的迫切需要。仍有太多国家既缺乏常规收集卫生数据的基础设施，也缺乏利用这些数据开展有效卫生行动和应急响应的分析能力。“各国必须能够衡量进展，才能取得进展，”世卫组织总干事谭德塞博士说。“尤其是在COVID-19期间，可靠的数据是协调应对工作、改善对公共卫生威胁的应对和恢复的最佳途径。”

Today, as part of its commitment to strengthening health information systems and improving health[1], especially in the context of the COVID-19 pandemic, WHO announced a new approach to improving access to life-saving data: the SCORE for Health Data Technical Package. The COVID-19 pandemic has highlighted the urgent need for timely and reliable data to drive strategic health action. Too many countries still lack both the infrastructure to routinely gather health data and the analytical capacity to use these data for effective health actions and emergency response. “Countries must be able to measure progress to make progress,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Particularly during COVID-19, reliable data is the best way to coordinate response efforts and improve healt

兽用药品委员会关于兽用药品的意见委员会在特殊情况下通过了关于Bovilis Lumpyvax（疙瘩…）上市许可的积极意见。

CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion, in exceptional circumstances, for a marketing authorisation for Bovilis Lumpyvax (lumpy…

欧盟临床试验加速计划（ACT EU）咨询试点项目旨在帮助申办者准备临床试验申请，将从2027年1月起成为一项常设举措……

The Accelerating Clinical Trials in the EU (ACT EU) advice pilot, which helps sponsors prepare clinical trial applications, will become a permanent initiative from January 2027…

在月度会议上，EMA的安全委员会（PRAC）履行了其管理药品安全的广泛职责，包括安全性评估…，议程 2026年9月28日至10月1日PRAC会议议程草案参考编号：EMA/PRAC/204838/2026…，PRAC统计：2026年10月 基于草案议程的PRAC结果月度数据。© 欧洲药品管理局，PRAC统计：…，进行中的转介 程序：肠外给药的含铁药品——转介，术语表 安全性信号评估。安全性信号是指提示存在新的潜在因果关联，或已知关联的新方面的信息…

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities to manage the safety of medicines, including the assessment of safety…, Agenda Agenda of the PRAC meeting 28 September - 1 October 2026Draft Reference Number: EMA/PRAC/204838/2026…, PRAC statistics: October 2026 Monthly figures for PRAC outcomes based on the draft agenda. © European Medicines Agency, PRAC statistics:…, Ongoing referrals Procedure: Parenteral iron-containing medicinal products - referral, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…

希望在2026年收到结果的上市许可持有人应提交IA类年度更新、单独的IA类和IAIN类变更，以及超级分组……

Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IAIN variations, and super-groupings…

执行董事的2026年年中报告EMA向管理委员会提交了其2026年上半年的运营成果和成就。在一月和……之间。

Mid-year report 2026 from the Executive DirectorEMA presented results and achievements of its operations for the first half of 2026 to the Management Board. Between January and…

欧洲药品管理局（EMA）已认可国际药品监管机构联盟（ICMRA）的联合声明，该声明呼吁药物开发者、制造商、监管机构以及……

EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and…

阿姆斯特丹，2026年9月28日 以实际演讲为准（正式发布的文本基于事先准备的讲稿。实际演讲中可能有细微差异） 早上好，……

Amsterdam, 28 September 2026Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery)Good morning,…

到2026年底，EMA将制定一份监管路线图，以帮助推动在药物开发和监管全过程中如何考虑女性健康方面作出决定性变革。这……，女性仍然缺位：从研究到数据、预防、诊断和治疗中皆是如此。但改善女性健康支持的势头从未如此强劲。……，有意义的变革始于对话，始于对我们所面临挑战的共同理解。我们以一条明确的行动路径结束本次研讨会。“国家监管……”，本次多方利益相关者研讨会进行了直播，汇集了来自欧盟和国际层面100多位女性健康领域的权威声音，涵盖从监管者到患者、医疗保健……

By the end of 2026, EMA will develop a regulatory roadmap to help drive decisive change on how women’s health is considered across medicines development and regulation. This…, Women are still missing: from research and data, prevention, diagnosis and treatment. But the momentum to improve support for women’s health has never been stronger.…, Meaningful change starts with dialogue and with a shared understanding of the challenges we face. We end this workshop with a clear path to action”, “National regulatory…, The multistakeholder workshop, broadcast live, brought together over 100 leading voices on women’s health at EU and international level, from regulators to patients, healthcare…

欧洲肿瘤内科学会（ESMO）关于早期和局部晚期非小细胞肺癌（NSCLC）患者的诊断、治疗与随访临床实践指南于2025年8月发布，并于2025年11月根据先前建立的标准方法进行改编，以产生泛亚洲改编版ESMO共识指南，用于管理亚洲早期和局部晚期NSCLC患者。…

The European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with early and locally advanced non-small-cell lung cancer (NSCLC) were published in August 2025 and were adapted in November 2025 according to previously established standard methodology to produce the Pan-Asian adapted ESMO consensus guidelines for the management of Asian patients with early and locally advanced NSCLC.…

这是iCARDIO联盟心力衰竭全球实施指南的2026年更新版，最初于2025年发布。在本指南中，我们旨在考虑医疗可及性方面的不一致、基础设施差异、资源限制以及各地不同的实践，同时兼顾限制现有指南全球适用性的实际问题和政治问题。有必要制定普遍适用的建议，以应对全球患者和医疗服务提供者所面临的独特挑战。…

This is the updated 2026 version of the iCARDIO Alliance Global Implementation Guidelines on Heart Failure - originally published in 2025. In these guidelines, we aim to consider inconsistencies in healthcare access, varying infrastructure, re-source constraints and diverse local practices as well as practical and political issues that restrict the global applicability of currently available guidelines. There is a need for universal recommendations that address the unique challenges faced by patients and healthcare providers worldwide.…

“世卫组织是一个养老院……我们必须重塑多边主义……我们必须对彼此更加坦诚……我们花在与完全不同意我们观点的人交谈上的时间不够……我很少见到可持续发展目标徽章……关于信任，人工智能不会有所帮助……利用科学产物传播反科学内容的悖论……我们不被负面情绪感染是极其重要的。”这些是上周在柏林举行的世界卫生峰会上，一场按查塔姆宫规则进行的会议中所交流的部分思考。

“WHO is a retirement home…We must reinvent multilateralism…We must be more candid with one another…We do not spend enough time talking with people who totally disagree with us…I have seen very few SDG badges…On trust, AI will not help…The paradox of using a product of science to disseminate anti-science…It's super-important we don't get infected by the negativity.” These were some of the reflections exchanged during a meeting, held under the Chatham House Rule, at last week's World Health Summit in Berlin.

在印度尼西亚这个庞大、多元的中等收入国家，COVID-19大流行给卫生系统带来了前所未有的压力，暴露了卫生不公平和低效率，并凸显了结构性改革的紧迫性。2020年12月，在COVID-19大流行最严重时期，我被任命为卫生部长，我的任务有两方面：应对眼前的危机，以及推行印度尼西亚历史上最雄心勃勃的卫生改革。

In Indonesia, a large, diverse, middle-income country, the COVID-19 pandemic placed unprecedented pressure on the health system, exposing health inequities and inefficiency, and underscoring the urgency for structural reform. When I was appointed as Minister of Health at the height of the COVID-19 pandemic in December, 2020, my mandate was two-fold: to manage the immediate crisis and to deliver the most ambitious health reform in Indonesia's history.

在死亡率上升了十多年之后，美国正经历着药物过量死亡人数出人意料且令人鼓舞的下降。根据美国疾病控制与预防中心的临时估计，2025年约有7万人死于药物过量——比2024年减少了近14%，这是自2022年近10.8万人的高点以来连续第三年下降。1,2 过量死亡人数的减少具有广泛性，因为美国几乎每个州报告的2025年过量死亡人数都低于前一年。

After more than a decade of rising mortality, the USA is experiencing an unexpected and encouraging decline in drug overdose deaths. According to provisional estimates from the US Centers for Disease Control and Prevention, approximately 70 000 people died from drug overdoses in 2025—nearly 14% fewer than in 2024, marking the third consecutive annual decline, from a high of almost 108 000 in 2022.1,2 The reduction in overdose deaths has been widespread, as nearly every state in the country reported fewer overdose deaths in 2025 compared with the previous year.

数字技术正在改变社会结构，但这种转变及其对公共卫生的影响在全球人口中的分布并不均衡。1 在《柳叶刀》关于健康数字决定因素（DDoH）的新系列中，作者提出了一种协调且系统化的方法，用于审视和应对数字化给全球健康与福祉带来的挑战。2–4 该系列指出，年轻人对社交媒体的使用是审视健康数字决定因素的一个重要起点。

Digital technologies are transforming societal structures, but this transformation and its public health impacts occur unevenly across the global population.1 In a new Lancet Series about the digital determinants of health (DDoH), the authors propose a coordinated and systemic approach for examining and responding to the challenges that digitalisation presents for global health and wellbeing.2–4 Social media use by young people emerges in the Series as an important starting point for examining the DDoH.

患者在看临床医生之前，越来越多地使用对话式人工智能（AI），包括用于可能的诊断。然而，临床证据缺乏，且大多为模拟证据。例如，Articulate Medical Intelligence Explorer（AMIE）在文本咨询中优于初级保健医生，但其“患者”是标准化病人。1 一个例外是一项纳入2069例患者的随机试验，在该试验中，聊天机器人可生成病史、初步诊断和检查医嘱，有时无需工作人员支持，尽管其主要结局主要关注效率。

Patients increasingly use conversational artificial intelligence (AI), including for possible diagnoses, before seeing a clinician. However, clinical evidence is lacking and is mostly synthetic. The Articulate Medical Intelligence Explorer (AMIE), for example, outperformed primary care physicians in text consultations, but its patients were patient actors.1 One exception is a randomised trial of 2069 patients in which a chatbot generated histories, preliminary diagnoses, and test orders, sometimes without staff support, although its primary outcomes focused mainly on efficiency.

由C1抑制剂缺乏所致的遗传性血管性水肿（HAE-C1INH）在临床上以复发性、通常不可预测的血管性水肿发作为特征。1未治疗的发作往往严重且持续时间长，可持续3–5天，并导致相当高的发病率甚至死亡率。2与肥大细胞介质相关的血管性水肿不同，HAE-C1INH的肿胀对抗组胺药、糖皮质激素或肾上腺素均无反应。

Hereditary angioedema due to a deficiency of C1 inhibitor (HAE-C1INH) is clinically characterised by recurrent, generally unpredictable attacks of angioedema.1 Untreated episodes are often severe and prolonged, lasting up to 3–5 days and engendering considerable morbidity and even mortality.2 Unlike angioedema associated with mast cell mediators, the swelling in HAE-C1INH does not respond to antihistamines, corticosteroids, or epinephrine.

镰状细胞病是最常见的血红蛋白病，全球患病人数超过700万。1尽管其发病率和死亡率都很高，但获得有效改善病情治疗的可及性仍然有限。2,3羟基脲和慢性输血均已被证明可减少镰状细胞病的急性并发症，包括血管闭塞性危象和卒中，同时也能改善血液学参数。4,5然而，在某些情况下，两者的可及性和长期可行性可能受到限制。

Sickle cell disease is the most common haemoglobinopathy, affecting more than 7 million people worldwide.1 Despite substantial morbidity and mortality, access to effective disease-modifying therapies remains limited.2,3 Hydroxyurea and chronic blood transfusions have both been shown to reduce acute sickle cell disease complications, including vaso-occlusive crises and stroke, while also improving haematological parameters.4,5 However, the availability and long-term feasibility of both could be limited in some settings.

还记得20世纪90年代万维网理想主义愿景的人，恐怕很少有人能预料到互联网会在如此大的程度上重塑现代生活。今天的孩子们从出生起就生活在一个没有智能手机和无处不在的数字连接就无法想象的世界里，他们必须面对网络羞辱和欺凌、永久的数字足迹，以及被武器化的注意力经济。生成式人工智能如今甚至能使我们脱离现实，一方面为一些人提供情感支持和陪伴，另一方面又将我们最私密的个人信息提供给市值数万亿美元的科技公司。

Few who remember the idealistic vision of the 1990s World Wide Web could have anticipated the extent to which the internet would reshape modern life. Today's children have never lived in a world without smartphones and ubiquitous digital connectivity, and must contend with online shaming and bullying, permanent digital footprints, and weaponised attention economies. Generative artificial intelligence can now detach us from reality, providing emotional support and companionship for some, while supplying our most personal disclosures to trillion-dollar tech companies.

《新英格兰医学杂志》，第395卷，第16期，第1665-1667页，2026年10月22日。

New England Journal of Medicine, Volume 395, Issue 16, Page 1665-1667, October 22, 2026.

《新英格兰医学杂志》，第395卷，第16期，第1662-1665页，2026年10月22日。

New England Journal of Medicine, Volume 395, Issue 16, Page 1662-1665, October 22, 2026.

《新英格兰医学杂志》，第395卷，第16期，第1621-1633页，2026年10月22日。

New England Journal of Medicine, Volume 395, Issue 16, Page 1621-1633, October 22, 2026.

《新英格兰医学杂志》，第395卷，第16期，第1649-1652页，2026年10月22日。

New England Journal of Medicine, Volume 395, Issue 16, Page 1649-1652, October 22, 2026.

《新英格兰医学杂志》，第395卷，第16期，第1585-1599页，2026年10月22日。

New England Journal of Medicine, Volume 395, Issue 16, Page 1585-1599, October 22, 2026.

这项部分随机交叉预试验评估了降低剂量的组氨瑞林用于母马诱导排卵的效果，并比较了肌内注射（IM）与在白会和雁翅穴位进行穴位注射的给药方式。共纳入11匹母马，其中9匹完成了全部八种方案并被纳入分析。方案包括250 µg组氨瑞林肌内注射（标准剂量）、75 µg肌内注射、25 µg肌内注射、不干预、白会穴注射生理盐水、雁翅穴注射生理盐水、白会穴注射25 µg组氨瑞林以及雁翅穴注射25 µg组氨瑞林。…

This partially randomized crossover pilot study evaluated reduced doses of histrelin for ovulation induction in mares and compared intramuscular (IM) administration with pharmacopuncture at the Bai-hui and Yan-chi acupoints. Eleven mares were enrolled, of which nine completed all eight protocols and were included in the analyses. The protocols comprised 250 µg histrelin IM (standard dose), 75 µg IM, 25 µg IM, no intervention, saline at Bai-hui, saline at Yan-chi, 25 µg histrelin at Bai-hui, and 25 µg histrelin at Yan-chi.…

背景：甜菜根汁（BRJ）已被提议作为运动性肌肉损伤（EIMD）后恢复的营养辅助手段，但在女子团体项目运动员中的证据有限。此外，其获益是否可延伸至功能、疼痛相关、肿胀及力量等多种结局指标，目前仍不清楚。方法：17名大学女子排球运动员进入一项随机、双盲、安慰剂对照交叉试验。4人未完成第二阶段，因此结局采用线性混合模型进行分析。…

BACKGROUND: Beetroot juice (BRJ) has been proposed as a nutritional aid for recovery from exercise-induced muscle damage (EIMD), but evidence in female team-sport athletes is limited. It also remains unclear whether any benefit extends across functional, pain-related, swelling, and strength outcomes. METHODS: Seventeen female university volleyball players entered a randomized, double-blind, placebo-controlled crossover trial. Four did not complete the second period, so outcomes were analyzed with linear mixed models.…

哮喘是一种慢性气道炎症性疾病，全球有超过3亿人受累。据估计，其中3%至10%患有重度哮喘。Depemokimab是首个针对2型呼吸道疾病开发的超长效抗IL-5单克隆抗体，可每26周给药一次。它能快速且持续地降低血嗜酸性粒细胞计数。这种每年两次的给药方案显著减少了注射频率，并可能减轻治疗负担。…

Asthma is a chronic inflammatory disease of the airways affecting more than 300 million people worldwide. It is estimated that between 3% and 10% have severe asthma. Depemokimab is the first ultra-long-acting anti-IL-5 monoclonal antibody developed for type 2 respiratory disease, enabling administration every 26 weeks. It produces rapid and sustained reductions in blood eosinophil counts. This twice-yearly regimen markedly reduces injection frequency and may lessen treatment burden.…

在本期中，我们重点介绍亨廷顿病治疗管线中的几项重要进展。我们讨论POINT-HD的启动及随后终止，该研究是RG6496（Hoffmann-La Roche）的首次人体I期研究，RG6496是一种等位基因选择性反义寡核苷酸，旨在选择性降低突变型亨廷顿蛋白，同时大体上保留野生型亨廷顿蛋白的表达。我们还讨论两项III期疗效试验的启动：评估votoplam（Novartis Pharmaceuticals）的INVEST-HD，以及评估pridopidine（Prilenia）的PRECISE-HD。…

In this edition, we highlight several important developments across the Huntington's disease therapeutic pipeline. We discuss the launch and subsequent discontinuation of POINT-HD, the first-in-human phase I study of RG6496 (Hoffmann-La Roche), an allele-selective antisense oligonucleotide designed to selectively lower mutant huntingtin while largely preserving wild-type huntingtin expression. We also discuss the launch of two phase III efficacy trials: INVEST-HD, evaluating votoplam (Novartis Pharmaceuticals), and PRECISE-HD, evaluating pridopidine (Prilenia).…

骨骼肌线粒体动力学失衡通过尚未完全阐明的机制促进2型糖尿病（T2D）的发生和进展。在此，我们研究了线粒体Rho GTP酶1（Miro1）——一种线粒体外膜酶——在调节2型糖尿病（T2D）骨骼肌胰岛素作用和葡萄糖稳态中的作用。在一项横断面临床研究中，我们发现Miro1在肥胖和T2D患者的骨骼肌中积聚，这一现象在T2D小鼠模型中也得到了进一步验证。…

Imbalanced skeletal muscle mitochondrial dynamics contribute to the onset and progression of type 2 diabetes (T2D) by mechanisms that remain incompletely understood. Here, we examined the role of Mitochondrial Rho GTPase 1 (Miro1), an outer mitochondrial membrane enzyme, in regulating skeletal muscle insulin action and glucose homeostasis in type 2 diabetes (T2D). In a cross-sectional clinical study, we show that Miro1 accumulates in the skeletal muscle of patients with obesity and T2D, which was further replicated in mouse models of T2D.…