更新于：2024-05-01

Depressive Disorder, Major

重度抑郁症

更新于：2024-05-01

基本信息

别名

DEPRESSIVE DISORDER MAJOR、Depression, Involutional、Depressive Disorder, Major

+ [72]

简介

Disorder in which five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. Symptoms include: depressed mood most of the day, nearly every daily; markedly diminished interest or pleasure in activities most of the day, nearly every day; significant weight loss when not dieting or weight gain; Insomnia or hypersomnia nearly every day; psychomotor agitation or retardation nearly every day; fatigue or loss of energy nearly every day; feelings of worthlessness or excessive or inappropriate guilt; diminished ability to think or concentrate, or indecisiveness, nearly every day; or recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt. (DSM-5)

关联

416

项与重度抑郁症相关的药物

Gepirone hydrochloride

吉哌隆

靶点

5-HT1A receptor

作用机制

5-HT1A receptor激动剂

在研机构

Fabre-Kramer Pharmaceuticals, Inc.

原研机构

Bristol Myers Squibb Co.

在研适应症

重度抑郁症 [+2]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-09-22

Zuranolone

祖拉诺龙

靶点

GABAA receptor

作用机制

GABAA receptor正向变构调节剂

在研机构

Biogen, Inc. [+1]

原研机构

SAGE Therapeutics, Inc.

在研适应症

产后抑郁症 [+1]

非在研适应症

躁郁症1型 [+6]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-08-04

Ansofaxine Hydrochloride

盐酸托鲁地文拉法辛

靶点

DAT x NET x SERT

作用机制

多巴胺重摄取抑制剂 [+2]

在研机构

山东绿叶制药有限公司 [+1]

原研机构

Luye Pharma Group Ltd.

在研适应症

抑郁症 [+3]

非在研适应症

慢性疼痛 [+3]

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2022-11-01

4,408

项与重度抑郁症相关的临床试验

NCT05118594 / Not yet recruitingN/AIIT

Open-trial to Prospectively Test the Feasibility of a Precision Psychotherapy System for Low-income Patients

The purpose of this study is to evaluate the feasibility of an evidence-based system to recommend core interventions, before the beginning of treatment, to psychotherapists treating low-income patients with depressive or anxiety disorders.

开始日期2026-02-01

申办/合作机构-

NCT04441008 / Not yet recruitingN/AIIT

Radical aiTBS Protocol for Intractable Depression

The overall objective of this current study is to evaluate the feasibility, safety, and tolerability of "high dose" aiTBS in psychiatric inpatient and outpatients with treatment-refractory unipolar, non-psychotic major depressive disorder, using patients receiving ECT as an active comparator. Developing a better understanding of the feasibility and tolerability of adapting this treatment to an acutely ill patient population could lead to huge breakthroughs for clinician decision-making and for the further optimization of brain stimulation depression protocols. The results of this study can help guide future confirmatory efficacy trials of high-dose aiTBS by providing a better understanding of how feasibility, safety and tolerability compare to ECT, as well as unforeseen challenges of its use.

开始日期2025-12-01

申办/合作机构

University of Iowa

NCT03787290 / Suspended临床2期

Examining Immune-Based Mechanisms of Action for Mild-Intensity Whole Body Hyperthermia (WBH) in the Treatment of Major Depressive Disorder

Overall, the objective of this pilot study is to utilize the IL-6 receptor antagonist tocilizumab to prospectively evaluate the role of IL-6 in the antidepressant and immunological effects of whole body hyperthermia (WBH). The study seeks to replicate findings thus far that WBH has an antidepressant effect by administering the intervention at a site not involved in studies to date. Moreover, the current proposal may help the investigators better understand the role of IL-6 in the pathogenesis and treatment of depression which might point to novel immune-based interventions for Major Depressive Disorder (MDD). Finally, the current proposal holds promise for better understanding of a novel treatment for MDD, which is among the leading causes of health-related disability in the world.

开始日期2025-12-01

申办/合作机构

The General Hospital Corp.

[+1]

100 项与重度抑郁症相关的临床结果

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100 项与重度抑郁症相关的转化医学

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0 项与重度抑郁症相关的专利（医药）

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48,431

项与重度抑郁症相关的文献（医药）

2024-09-01·Neural regeneration research

Microglial NLRP3 inflammasome-mediated neuroinflammation and therapeutic strategies in depression.

Article

作者: Qiuqin Han ; Wenhui Li ; Peiqing Chen ; Lijuan Wang ; Xiwen Bao ; Renyan Huang ; Guobin Liu ; Xiaorong Chen

Previous studies have demonstrated a bidirectional relationship between inflammation and depression. Activation of the nucleotide-binding oligomerization domain, leucine-rich repeat, and NLR family pyrin domain-containing 3 (NLRP3) inflammasomes is closely related to the pathogenesis of various neurological diseases. In patients with major depressive disorder, NLRP3 inflammasome levels are significantly elevated. Understanding the role that NLRP3 inflammasome-mediated neuroinflammation plays in the pathogenesis of depression may be beneficial for future therapeutic strategies. In this review, we aimed to elucidate the mechanisms that lead to the activation of the NLRP3 inflammasome in depression as well as to provide insight into therapeutic strategies that target the NLRP3 inflammasome. Moreover, we outlined various therapeutic strategies that target the NLRP3 inflammasome, including NLRP3 inflammatory pathway inhibitors, natural compounds, and other therapeutic compounds that have been shown to be effective in treating depression. Additionally, we summarized the application of NLRP3 inflammasome inhibitors in clinical trials related to depression. Currently, there is a scarcity of clinical trials dedicated to investigating the applications of NLRP3 inflammasome inhibitors in depression treatment. The modulation of NLRP3 inflammasomes in microglia holds promise for the management of depression. Further investigations are necessary to ascertain the efficacy and safety of these therapeutic approaches as potential novel antidepressant treatments.

2024-06-01·IBRO neuroscience reports

Assessing remission in major depressive disorder using a functional-structural data fusion pipeline: A CAN-BIND-1 study.

Article

作者: Sondos Ayyash ; Andrew D Davis ; Gésine L Alders ; Glenda MacQueen ; Stephen C Strother ; Stefanie Hassel ; Mojdeh Zamyadi ; Stephen R Arnott ; Jacqueline K Harris ; Raymond W Lam ; Roumen Milev ; Daniel J Müller ; Sidney H Kennedy ; Susan Rotzinger ; Benicio N Frey ; Luciano Minuzzi ; Geoffrey B Hall ; CAN-BIND Investigator Team

Neural network-level changes underlying symptom remission in major depressive disorder (MDD) are often studied from a single perspective. Multimodal approaches to assess neuropsychiatric disorders are evolving, as they offer richer information about brain networks. A FATCAT-awFC pipeline was developed to integrate a computationally intense data fusion method with a toolbox, to produce a faster and more intuitive pipeline for combining functional connectivity with structural connectivity (denoted as anatomically weighted functional connectivity (awFC)). Ninety-three participants from the Canadian Biomarker Integration Network for Depression study (CAN-BIND-1) were included. Patients with MDD were treated with 8 weeks of escitalopram and adjunctive aripiprazole for another 8 weeks. Between-group connectivity (SC, FC, awFC) comparisons contrasted remitters (REM) with non-remitters (NREM) at baseline and 8 weeks. Additionally, a longitudinal study analysis was performed to compare connectivity changes across time for REM, from baseline to week-8. Association between cognitive variables and connectivity were also assessed. REM were distinguished from NREM by lower awFC within the default mode, frontoparietal, and ventral attention networks. Compared to REM at baseline, REM at week-8 revealed increased awFC within the dorsal attention network and decreased awFC within the frontoparietal network. A medium effect size was observed for most results. AwFC in the frontoparietal network was associated with neurocognitive index and cognitive flexibility for the NREM group at week-8. In conclusion, the FATCAT-awFC pipeline has the benefit of providing insight on the 'full picture' of connectivity changes for REMs and NREMs while making for an easy intuitive approach.

2024-06-01·MethodsX

Modified inverse propensity weighting method to alleviate estimation errors in the model with multiple endogenous variables.

Article

作者: Bhubaneswor Dhakal ; Geraldine F H McLeod ; Andrea Insch ; Joseph M Boden

Multiple mental health disorders affect on decisions of people. The disorders are also outcomes of other factors. Health studies commonly follow an inverse propensity weight (IPW) method to address estimation errors associated with the presence of one confounder or covariate number exceeding the recommended sample size. However, approaches of IPW appropriate to alleviate the estimation error associated with multiple confounders distributed unequally in the study samples were not explained in our search literature. This study used longitudinal cohort data from Christchurch Health and Development Study and demonstrated IPW approach to address two confounders with similar natures in terms of etiological process. In our sample, some individuals had no mental health disorder at all, while others had either one of depression or anxiety or both. The methodological step to evaluate a new IPW approach include * Estimated IPWs from all possible combinations of the major depression and anxiety disorder: (a) IPW based on anxiety factor only assuming both mental health problems resulted from the same etiological processes; (b) IPW based on major depression factor only assuming both mental health problems resulted from the same etiological processes; (c) IPW assuming three (independent) categories of etiological processes: neither; either; both of major depression or anxiety disorder, (d) IPW assuming four (independent) categories of etiological processes: neither; major depression only; any anxiety disorder only; both. (e) No IPW or control model (no confounding problem.•Estimated outcome model with one each IPW at a time and one without IPw (control model).•Compared fit statistics of all estimated models.•The IPW derived assuming four categories of etiological processes produced the robust based fit statistics criteria. The study showed significant effects of both mental health problems on investment but the anxiety revealed a stronger effect than that of major depression.

1,581

项与重度抑郁症相关的新闻（医药）

2024-04-07

·医药地理

【药闻·FDA】抗抑郁治疗新技术：FDA批准Rejoyn上市

抗抑郁治疗新技术：FDA批准Rejoyn上市2024年3月30日美国FDA批准Rejoyn上市。Q:什么是Rejoyn？A: Rejoyn由大冢美国制药有限公司研发并申请上市，是一款数字治疗App，可辅助临床医生开展疾病管理工作。Q:适用于什么疾病？A: 22岁及以上应用抗抑郁药物的重度抑郁症(major depressive disorder，MDD)患者，旨在减轻MDD症状。Q:可以提供什么服务？A: Rejoyn可提供交互式认知-情感及行为治疗，包括基于认知行为治疗的课程，以及向患者推送信息以强化课程内容，并鼓励使用该App。参考：FDA官网本刊主管单位为上海医药工业研究院，由上海医药工业研究院、中国药学会主办，原名《国外医药——合成药、生化药、制剂分册》，1980年创刊，2003年起经国家新闻出版总署批准更名为《世界临床药物》。曾获国家“医药信息成果奖”、华东地区优秀期刊等奖项。为中国科技核心期刊（中国科技论文统计源期刊）、中国学术期刊综合评价数据库来源期刊、中国生物医学期刊文献数据库统计源期刊、中国学术期刊评价报告RCCSE中国核心（扩展版）学术期刊，被药学文摘、美国化学文摘（CA）和波兰哥白尼索引（IC）等收录。本刊全面介绍国内外最新药物治疗信息、临床用药经验和药物不良反应。目前设有 “医药专论”、“研究论文”（论著，简报，探讨&交流）、综述评论（药物开发，临床研究，应用评价，政策管理，医药市场）、信息（全球医药快讯，上市新药，治疗指南）等栏目，特邀临床专家解读最新治疗指南，由国内临床一线专家参与组织和撰写的专题综述，颇具权威性和指导意义。对国外临床指南及其更新的关注和点评，客观全面的药物疗效及不良反应评价，均有助于我国医疗卫生事业的发展，切实提高我国临床用药水平。本刊主要面向临床医师、药师和药事管理人员，以及医药企业、高等院校、研究机构的科研、管理和营销人员，是我国医药工作者了解全球医药动态的专业媒体。本刊得到国内临床知名专家和权威人士的大力支持，编委有来自全国临床一线的资深专家、科研院所及高等院校的医药研发工作者。刊物发行面广，读者覆盖全国30多个省市的三级甲等和二级甲等医院数千家。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

上市批准一致性评价

2024-04-06

·E药经理人

一款“死而复生”老药撑起40倍股价！曾获高瓴投资，这家Biotech凭什么突围？

这是一家凭借一款产品实现跃升的明星Biotech。撰文| Qsher Kathy编辑| 芳晨这是【锐·公司】系列的第6期，如想了解更多，请滑到文章底部！这样的故事有很多，但它的不同之处在于，旗下不过区区几款在研产品，唯一自研获批上市的一款新药还属于“老药新用”，凭借两大“老分子”，却研发出了创新机制，攻克研发洼地，重度抑郁症、阿尔茨海默……直接实现身价翻倍，股价从2019年初的2块多，飙升到年底109.94，一年涨幅超过40倍，一举成为当年涨幅最凶猛的Biotech公司。不过一些紧接着的问题来了，这款药凭什么撑起估值？它的策略胜在何处？如何完成自我迭代？如何破局专利掣肘？商业化策略如何？事实上，CNS药物开发失败率高早成为产业界公认难题，这或亦是业界对该领域在研产品临床进展反应更为敏感的主因之一。一面是开发空间大，吸引着大家争相抢入，另一面是失败率居高不下，折戟了一批企业和产品，药企仍需负重前行，为什么它能突出重围？有了一款起死回生的重磅炸弹后，Axsome能延续成功吗？推荐阅读 * 股价大涨1300%！从无名小卒到杀进CRO全球TOP10，Medpace凭啥？* 16年无新药上市，之后平均1年1款，股价上涨33倍，这家Biotech做对了什么？一款“死而复生”潜在重磅炸弹背后Auvelity（AXS-05）凭什么能撑起Axsome估值？这就脱离不了抗抑郁药物研发背景来说。精神疾病因其发病机制不明，药物研发难度大，该领域一直是创新药物的“研发洼地”：在过去十年间，相比肿瘤领域动辄每年数十个新药获批，获得FDA批准的抗抑郁药物一只手就能数得过来。此前，抗抑郁疗法几乎基于单胺类神经递质。一般而言，抗抑郁药物研发耗时长，主要基于两大原因，一是由于药物的副作用；二是由于药物的起效慢。目前主要机制基本围绕调节情绪因子，如5-羟色胺、去甲肾上腺素和多巴胺。按理说，市场也并不乏抑郁症产品，Auvelity为何如此受重视？关键点在于，它的获批代表着超过60年来，首款不基于单胺类神经递质的抑郁症口服疗法来了，一度代表着抑郁症治疗领域的一大里程碑。实际上，还未正式获批，Auvelity便被外界投注期待，被视为有望成为明星重磅产品。Auvelity研发思路较为“巧妙”，用品并不稀奇，效果却出人意料，用非新分子，产生了创新作用机制。它是两种已获批药物的组合，即一款右美沙芬（45mg）+安非他酮（105mg）复方缓释片。此前产业界一大共识是，自上世纪50年代以来，精神类的药物就大都以“打补丁”或者“调结构”的方式开发，也就是把作用于不同递质或靶点的药进行化学结构组合。这个组合中，右美沙芬充当NMDA受体拮抗剂，并起到调节谷氨酸神经传递等作用；而安非他酮可以增加右美沙芬的生物利用度，还能作为去甲肾上腺素和多巴胺再摄取抑制剂起效。由此成为全球目前为止唯一一款口服速效NMDA（一种离子型谷氨酸）受体拮抗剂。这就解决了几大关键问题，基于新机理的Auvelity能够弥补传统单胺抗抑郁药物见效慢的弊端，时效性明显更强，甚至有望治疗传统药物无效的疑难患者。相较市场上其它抑郁症有所不同，Auvelity是一种治疗重度抑郁症的速效药物，在用药一周后就能观察到效果并且持续产生疗效。而彼时市面上的抑郁症药物的典型反应时间为六到八周。简而言之，该药具有起效快、作用强、机制新、不增重等优势，拥有口服NMDA拮抗剂的创新作用机制，经临床试验证明的快速抗抑郁效果和相对良好的安全性特征。回溯Auvelity十年研发和审批之路，却道阻且艰，一波三折。它最初是伴随着2012年Axsome成立之际，从创始人之一Herriot Tabuteau拥有的知识产权公司Antecip Bioventures II LLC 处获得开发、制造和商业化权利。Auvelity尚在研时，代号为AXS-05。起初，这款药还未掀起太大波澜，直到后期临床数据接连披露，才开始频繁进入大众视野。伴随着2019年3月，Auvelity被美国FDA认定为用于治疗抑郁症的突破性疗法后，更是刺激了市场，直接使Axsome一跃成为明星股，同时也是当年涨幅最凶猛的生物科技股。不过，自此，该公司的股价就伴随着这款药物研发进展、审批进度，开启了大起大落的人生。涨势延续至2020年，Axsome准备乘热打铁，于2021年8月提交了上市申请，但不幸的是，但由于新药申请存在缺陷，FDA宣布推迟其批准决定。彼时，Axsome的股价两天内暴跌超过50%。这致使获批时间整整推迟了一年。2022年8月，FDA批准Auvelity用于治疗重度抑郁症。两个月后，即 2022 年 10 月开始在美国进行 Auvelity 的商业化销售。甫一上市，彼时直接轰动了“CNS圈”，更是在2023年中收获了高瓴资本建仓。除了已获批上市的抑郁症适应证，Axsome还围绕 Auvelity展开多个适应证的“围墙”，用于治疗阿尔茨海默症激越和戒烟。目前已获得 FDA 针对阿尔茨海默病激越的突破性疗法认定，都是当下的研发洼地。辉煌还能延续吗？成立于2012年的Axsome，并非“一穷二白”出世。两位创始人Herriot Tabuteau与Mark Jacobson的背景迥异。HerriotTabuteau拥有医学和商业背景，在创立Axsome之前，曾在制药行业担任过各种领导职务，创立Axsome时，Herriot Tabuteau自带家底投注其中。值得注意的是，成立之初，Axsome与创始人Herriot Tabuteau拥有的知识产权的公司Antecip Bioventures II LLC 公司签订了多项独家许可协议，从而获得了开发、制造和商业化 Antecip与 AXS-02、AXS-05 （即：Auvelity）等开发相关的专利和应用的独家许可。这直接奠定了后续Axsome研发的基础。相较Herriot Tabuteau的商业背景，另一位创始人MarkJacobson则是一位神经学家，在CNS疾病方面拥有专业知识，并为Axsome产品线的科学和临床开发做出了贡献。早年间，和国内大多Biotech的故事一样，团队规模不大，专注于早期研发。不过，伴随着产品获批上市，也意味着Axsome从研发阶段进入了产品商业化的历史关键时刻。面对众多竞争对手，Axsome凭借其创新能力和市场敏锐度，试图不断推出具有竞争力的新产品，巩固和拓展其市场份额。根据Research and Markets此前的一项市场分析，Auvelity在2029年的销售额可能高达13亿美元，占全球预期的79亿美元总市场规模的很大一部分。Axsome也早早为此做了准备，提前组建起了一支具有丰富商业化经验的管理团队，接受市场的“拷问”。曾就职于艾伯维的Maizel 自 2023 年 10 月起担任Axsome执行副总裁兼商务主管。在加入 Axsome 之前，Maizel曾是艾伯维美国精神病学副总裁，负责监督数十亿美元特许经营权的销售和营销。同时期，Axsome还任命了Englebert为公司产品战略执行副总裁，从履历来看，Englebert曾在安进、诺华工作十余年，担任商业、企业战略和业务发展方面的领导职务，包括负责多个商业产品的发布。值得注意的是，在获批遭推迟的一年，Axsome也并未“闲着”，除了整改重新提交申请外，在等待获批期间，Axsome组建了一个超150名员工的销售团队。彼时，据该公司透露，此销售团队将服务于包括精神科医生和其他心理健康顾问等在内的约2.5万名美国医疗保健提供者。这些行业人士将覆盖Auvelity约70%的潜在市场。商业化一年后，销售团队仍在持续扩张。Auvelity获批后，除了商业化的挑战，Axsome自身乃至业界更大的担忧可能在于专利保护。Auvelity作为一款复方制剂，相较于目前已经上市的氯胺酮类药物而言，没有显著的成瘾副作用，同时兼具了起效快和药效持久的优势，但复方制剂的最大挑战是专利保护和药物定价。“因为两个单药都已经过了专利期了，有大量价格低廉的仿制药，这类药物如果定价高了，那么医生可以开两个单药，复方的专利是很难保护的，在科学和医学上的意义大于商业上的意义。”曾有业内人士介绍，两个“老药”药物分子本身的专利无法得到保护，联用是组合的专利保护，药物的联用又比较复杂，这也是“老药”模式遇到的比较大的挑战。摆在Axsome面前的一大问题是，怎么突破专利掣肘？Axsome正在交出它的答卷：构建专利围墙。截至 2023年2月21日，Axsome的知识产权组合已经包含300项已颁发的专利和400多项在美国和全球的待决申请。其中，Auvelity拥有超过114项已颁发的美国专利和70多项已颁发的外国专利，其权利要求涵盖治疗方法、药物成分、药物递送和药代动力学，保护期至2034年和2040年。到了今年，Axsome专利布局更加明确。截至今年2月13日，Axsome知识产权组合包含600多项已颁发专利和400多项在美国和全球的待决申请。Auvelity拥有超过127项已颁发的美国专利和超过76项已颁发的外国专利，其权利要求涵盖治疗方法、药物成分、药物递送和药代动力学，保护期更是延长至2043年。不单是Auvelity一直在延长专利保护期，AXS-07、AXS-12 等产品同样如此。曾经乘着AXS-05的临床数据东风扶摇而上，又只FDA的一封审评信跌到谷底，好在随着产品获批Axsome再次起死回生。AXS-05之于Axsome可以说是成也萧何，败也萧何。有了一款起死回生的重磅炸弹后，Axsome能延续成功吗？或许要看AXS-05能延续的“生命力”以及后续其他管线的持续输血能力了。关于【锐·公司】【自2023年，医药行业整体呈现震荡下行趋势。在当前的资本调整期，生物医药产业的预期减弱、资本市场低迷、企业融资困难等因素接连出现。资本下行周期的迷雾中，融资不顺、上市受阻、IPO破发，引发系列连锁反应，裁员、关厂、砍管线，昔日匆忙赶路Biotech们的未来被蒙上一层灰尘。进入2024年，产业依然在等寒冬过去，等春暖花开。如果纵观美国的生物医药产业，曾经历过5次周期震荡，“幸存者”们或在资金、产品、商业化、团队管理上有所专长。纵然身处前路不明的迷雾中，但却不能踌躇不前。E药经理人推出“锐·公司”专题，希望通过洞察那些或跑赢行业、或曾穿越周期的锐不可挡的biotech公司们屹立不倒的特性与共性，寻找中国生物医药产业成功穿越周期的答案。欢迎后台留言自荐！】精彩推荐CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

医药出海

2024-04-05

·FiercePharma

Fierce Pharma Asia—Eisai's subQ Leqembi delay; Legend and J&J's supply deal with Novartis; China's Ozempic biosimilar

The delay for an injectable version of Leqembi, an expanded CAR-T manufacturing deal for Carvykti and the first Ozempic biosimilar filing in China made our news this week. Eisai and Biogen's subcutaneous Leqembi faces a regulatory delay. Johnson & Johnson and Legend Biotech have expanded their contract manufacturing deal with Novartis around Carvykti. A Chinese drugmaker is seeking local approval of a biosimilar version of Novo Nordisk's Ozempic. And more. 1. Eisai, Biogen's injectable Leqembi delayed as FDA asks for more data The FDA is asking for more data on an injectable version of Eisai and Biogen’s Leqembi. The demand has caused the delay in the formulation’s filing, because Eisai can’t start a rolling submission without first gaining a “fast track” designation. Analysts have hoped that a more convenient injection could help accelerated uptake of the currently infused Alzheimer’s disease drug. 2. J&J, Legend expand manufacturing deal with Novartis to include commercial production of Carvykti Legend Biotech and Johnson & Johnson have expanded a contract manufacturing deal with Novartis to now include both clinical and commercial manufacturing of the pair’s CAR-T therapy Carvykti. The new deal runs through the end of 2029 and will see Novartis produce Carvykti at its Morris Plains plant in New Jersey. The new pact comes as Carvykti looks on track to enter earlier treatment of multiple myeloma. 3. First biosimilar to Novo’s Ozempic seeks approval in China (Reuters) A Chinese drugmaker, Jiuyuan Gene Engineering of Hangzhou, said it has sought local approval of a biosimilar version of Novo Nordisk’s diabetes drug Ozempic. The company names the drug Jiyoutai and noted that it was the first to file an application for a copycat of semaglutide, the active ingredient of Ozempic. According to Novo’s annual report, its Ozempic patents in China are set to expire in 2026. 4. Otsuka, Click Therapeutics snag FDA clearance for depression therapy app Otsuka and Click Therapeutics have secured FDA clearance for the first prescription digital therapeutic for major depressive disorder. The six-week digital program, called Rejoyn, is used alongside antidepressant drugs. The treatment provides cognitive emotional training exercises and therapeutic lessons. A 13-week randomized study showed that Rejoyn was better than a sham app at improving depression symptoms. 5. Ascletis pulls FXR agonist from pipeline over phase 2 primary biliary cholangitis data Chinese biotech Ascletis has reduced its development programs for the FXR agonist ASC42 after phase 2 data indicated the drug “did not show competitiveness” to other candidates in primary biliary cholangitis. As a result, the company has decided not to pursue further development of the drug for hepatitis B virus or as part of a combo treatment for metabolic-associated steatohepatitis. Other News of Note: 6. Aurobindo's Eugia recalls one lot of muscle relaxant because of possible contamination 7. Hutchmed, Innovent’s drug combo targets China approval in endometrial cancer (release)