Group 1 - The FDA has approved Capita for the treatment of major depressive disorder, marking a significant advancement in the field [1][2] - Johnson & Johnson (J&J) is recognized for its pioneering efforts in addressing mental health issues, including suicide prevention and major depressive disorder [2] - The approval of Capita is expected to have a substantive impact on the market and add to J&J's portfolio of mental health treatments [2] Group 2 - Everimmune, a biotech company focused on chronic inflammatory diseases, is celebrating its IPO at Nasdaq [3] - Billion to One, a molecular diagnostics company, is also marking its five-year anniversary, highlighting its success in the diagnostics sector [3]

搭载进博"快车"，加速让更多前沿解决方案惠及中国病患，这是强生医疗科技的美好期待！ 在第八届中国国际进口博览会期间，强生医疗科技聚焦脑血管疾病治疗领域，携端到端血栓控制产 品解决方案及颅内动脉瘤介入治疗新利器正式亮相，其中包括"亚洲首秀"CEREGLIDE 71远端通路导管 和"进博首秀"强易达血流导向密网支架。 从完整取栓方案的首次呈现，到本土合作创新成果的初次亮相，强生医疗科技以本届进博会为契 机，交出了一份融合全球创新和本土智慧的答卷。未来，公司将继续引进更多神经介入领域的先进技术 与产品，并和各方同道一起，为中国脑血管疾病患者构筑起更坚实的健康屏障，为推动我国神经介入诊 疗水平升级注入更强动力 。 全球负担疾病研究数据显示，卒中已经成为我国居民死亡的首位病因。作为治疗手段之一，机械取 栓愈发成熟。但一项研究显示，在对急性大血管性闭塞性脑卒中的患者行机械取栓术中，仍有约1/6的 患者出现因机械取栓失败导致脑组织无法实现再灌注。其背后的主要原因是解剖通路困难引起的器械无 法到达、通过狭窄或闭塞的部位，导致无法实现再灌注。 随着CEREGLIDE 71的首秀，这也是强生医疗科技首次携包括EMBOTRAP I ...

新京报讯（记者王卡拉）11月6日，强生医疗科技在第八届进博会上宣布，旗下ETHICON 4000作为目 前强生全球首款3D立体成钉腔镜吻合器亚洲首发上市，率先服务中国患者。该产品开创式地突破传统B 型平面成钉技术，实现从二维到三维的突破。其神经介入领域的"亚洲首秀"CEREGLIDE 71远端通路导 管和"进博首秀"强易达血流导向密网支架也在同日亮相。 在外科手术中，吻合组织的完整性对于患者术后恢复以及预防并发症至关重要。由于组织厚度不均、质 地脆弱等因素，吻合钉可能无法牢固紧密地固定组织，进而导致血液渗漏，增加患者的术中风险。此 外，如吻合钉未能完全闭合，这些"不良成钉"都可能成为组织渗漏的隐患点，增加患者感染、二次手术 或住院时间延长的可能。ETHICON 4000腔镜吻合器独家搭载强生全球首款3D立体成钉钉仓，实现从二 维到三维的结构性突破，3D立体结构能够让吻合钉以更全面的角度充分贴合组织，提升吻合完整性， 从而降低因缝合不严引起的血液渗漏。同时，结合创新的预置芯片技术，ETHICON 4000腔镜吻合器可 动态调节吻合进程，有助于减少术后并发症，改善患者预后。 "亚洲首秀"CEREGLIDE 71远 ...

The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson's drug Caplyta as an add-on treatment for adults with major depressive disorder, the company said on Thursday. ...

Accessibility StatementSkip Navigation CAPLYTA, in combination with an oral antidepressant, demonstrated superior efficacy with a favorable safety and tolerability profile consistent with established indications In pivotal trials, CAPLYTA did not increase mean weight gain, metabolic changes, or reported sexual side effects Experience the full interactive Multichannel News Release here: https://www.multivu.com/johnson-and- johnson/9355651-en-johnson-and-johnson-fda-approval-caplyta-lumateperone MDD, or clini ...

Core Insights - The cell and gene therapy (CGT) sector is experiencing a dichotomy, with major pharmaceutical companies entering the CAR-T therapy space while others are exiting, indicating a complex market landscape [1][2][10]. Group 1: Market Dynamics - The CGT market has seen rapid growth, with 46 CGT products approved by the FDA and approximately 3,600 active INDs [2]. - Despite the approval of over 10 CAR-T therapies globally, only a few have achieved blockbuster status, with Gilead's Yescarta showing a sales growth of only 4.81% in 2024 [3][4]. - The commercial performance of most CAR-T therapies has been disappointing, with high costs and market access issues limiting their success [6][9]. Group 2: Economic Challenges - The CGT sector faces significant economic challenges, including high R&D costs (estimated at $1.7 to $2.3 billion for CGT drugs compared to $1.25 to $1.48 billion for traditional drugs) and high production costs due to the personalized nature of treatments [11][12]. - The pricing of CAR-T therapies is exorbitant, with Carvykti priced over $500,000 in the U.S. and similar high costs in China, which restricts market accessibility [8][13]. Group 3: Industry Exits - Major multinational corporations (MNCs) like Takeda and Novo Nordisk have announced exits from the CGT space, indicating a shift in focus from technology-driven enthusiasm to financial viability [10][11]. - The industry's narrative has shifted from a focus on unique treatment mechanisms to a more pragmatic assessment of economic returns, highlighting the unsustainable nature of current CGT investments [11]. Group 4: Path to Recovery - The CGT industry is exploring various strategies to overcome its challenges, including the development of off-the-shelf CAR-T therapies to reduce costs and improve accessibility [14]. - Expanding the indications for CGT drugs to target larger patient populations is seen as a potential avenue for growth, similar to how Novartis expanded the application of siRNA therapies [17]. - The shift towards in vivo CAR-T therapies aims to simplify processes and reduce costs significantly, with predictions suggesting treatment costs could drop by an order of magnitude [18]. Group 5: Future Directions - The future of the CGT sector hinges on technological advancements that enhance accessibility, with a focus on universal CAR-T, in vivo therapies, and next-generation delivery technologies [19]. - The strategic movements of MNCs signal a paradigm shift in the industry, emphasizing the need to convert cutting-edge technology into sustainable business models for long-term success [19].

Core Insights - Samsung Bioepis has entered into a settlement and license agreement with Johnson & Johnson for the commercialization of PYZCHIVA® in Europe [1] Company Summary - The agreement allows Samsung Bioepis to commercialize PYZCHIVA®, which is a biosimilar product, in the European market [1]

（原标题：药械高管热议进博：与中国同行，持续推动医疗健康行业高质量发展） 21世纪经济报道记者季媛媛报道 中国持续深化的开放实践已转化为实实在在的机遇。日益完善的本土医疗创新生态，不仅吸引全球经验在此落地，也推动中国创新走向世界，为 全球医疗健康事业注入强劲动能。 11月5日，据新华社报道，国务院总理李强在上海出席第八届中国国际进口博览会（以下简称"进博会"）暨虹桥国际经济论坛开幕式，并发表主旨 演讲。李强表示，进博会是世界经济通向中国经济的入海口，也是中国联结世界的重要桥梁。 今年进博会的参展企业数量再创历史新高，充分彰 显中国超大规模市场的蓬勃生机和活力。面向未来，中国将继续坚定不移地推进高水平对外开放，让更多外国优质商品和服务进入中国市场。中 国坚持开放合作、互利共赢的强烈信号，为外资企业在华长期发展提供了更明确的政策方向和稳定预期。 对此，多家参展进博会的药械企业高管对21世纪经济报道记者表示，深受总理讲话精神的鼓舞。在众多药械高管看来，进博会为外资企业搭建了 一个与中国市场深度对接的重要平台。目前，进博会已成为药械企业探索中国机遇、加强沟通交流的宝贵平台，借助这一平台，跨国药械企业得 以更深入地融入 ...

Nov 5, 2025 4:50 PM Eastern Standard Time Johnson & Johnson to Participate in the Citi's 2025 Global Healthcare Conference Share NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) will present at the Citi's 2025 Global Healthcare Conference on Wednesday, December 3, 2025. Management will participate in a Fireside Chat at 11:15 a.m. Eastern Time. A live audio webcast of the presentation will be accessible through Johnson & Johnson's Investor Relations website at www.investor.jnj.com. An arch ...

In this week’s edition of InnovationRx, we look at the battle for Metsera, the departure of FDA’s top drug regulator, Kimberly-Clark’s $40 billion Kenvue deal, and more. To get it in your inbox, subscribe here.gettyThe battle between Novo Nordisk and Pfizer over Metsera, a three-year-old company working on treatments for obesity and diabetes, escalated this week.Last Thursday, Novo Nordisk made an unsolicited bid for Metsera valued at up to $9 billion–nearly 25% higher than Pfizer’s earlier bid for the comp ...