Floxuridine

药械追踪 No.1 / Zymeworks/百济神州泽尼达妥单抗获FDA加速批准，罗氏伴随诊断同步获批 2024年11月21日，Zymeworks Inc.（纳斯达克股票代码：ZYME）和Jazz Pharmaceuticals共同宣布，泽尼达妥单抗（zanidatamab，商品名：Ziihera）已获美国食品药品管理局（FDA）加速批准，用于经治、不可切除或转移性HER2阳性（IHC 3+）胆管癌（BTC）成人患者；罗氏PATHWAY HER2（4B5）检测同步获得FDA批准，作为伴随诊断识别适合接受泽尼达妥单抗HER2靶向治疗的BTC患者。 泽尼达妥单抗是一款靶向HER2的双特异性抗体，能够同时结合HER2的两个非重叠表位。本次获得加速批准基于HERIZON-BTC-01临床试验的独立中心审查（ICR）结果，受试者客观缓解率（ORR）达到52%，中位缓解持续时间（DOR）为14.9个月。 罗氏PATHWAY HER2（4B5）检测是一款抗HER2/neu（4B5）兔单克隆一抗，此前已获批作为辅助工具识别符合HER2靶向治疗条件的乳腺癌患者；本次新增获批BTC适应证辅助诊断，将进一步扩大该检测的应用范围。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / GSK Blenrep一线治疗MM上市申请获美国FDA受理 2024年11月25日，葛兰素史克宣布，旗下Blenrep（贝兰妥单抗莫福汀）联合硼替佐米加地塞米松（BorDex）及泊马度胺加地塞米松（PomDex）治疗至少接受过一线治疗的多发性骨髓瘤患者上市申请获美国FDA受理。 贝兰妥单抗莫福汀是一款靶向B细胞成熟抗原（BCMA）的抗体偶联药物（ADC），其连接子从Seagen授权引进，抗体是使用由协和麒麟集团成员BioWa Inc.许可的POTELLIGENT技术生产的。2020年，贝兰妥单抗莫福汀首次在美国和欧盟获得有条件上市许可，作为单药治疗四线r/r MM，但在DREAMM-3研究未能证实其临床获益后，该药物于2022年开始从这两个市场撤出。其作为联合治疗方案一部分的全球临床试验正在进行中。 ->点击文末阅读原文，解锁完整双语新闻 企业动态 No.1 / 罗氏斥资15亿美元收购通用CAR-T疗法公司Poseida 2024年11月26日，Poseida Therapeutics（NSDQ：PSTX）宣布已签订合并协议，公司将被Roche Holdings收购，总股权价值约为15亿美元。Poseida的董事会一致建议Poseida股东在收购要约中出售其股份。目前预计该交易将于2025年第一季度完成。 此次收购将为罗氏构建同种异体细胞治疗领域新的核心能力，交易完成后，罗氏将获得Poseida的GMP制造能力和其他研发组合资产。此次收购建立在双方2022年8月战略合作的基础上，当时交易双方专注于合作开发针对血液系统恶性肿瘤的同种异体CAR-T疗法。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 波士顿科学收购Intera Oncology，获得肝脏肿瘤介入治疗设备 2024年11月25日，波士顿科学公司（纽约证券交易所代码：BSX）宣布达成一项最终协议，将收购私有医疗设备公司Intera Oncology，并获得Intera 3000肝动脉输注泵和化疗药物氟脲苷。 Intera 3000肝动脉输注泵已获FDA批准，可用于实施肝动脉输注（HAI）疗法。Intera 3000肝动脉输注泵可为肝脏持续输注氟尿苷，以治疗由结直肠癌转移引起的肝脏肿瘤。 波士顿科学公司预计，该收购交易将在2025年上半年完成，但须满足成交条件。 ->点击文末阅读原文，解锁完整双语新闻 行业政策 No.1 / 医保局将于11月28日公布新版医保目录名单 据国家医保局11月26日消息，将于11月28日（本周四）上午十时在国家医保局召开新闻发布会，并于当天公布国家医保谈判结果。 2024年国家医保谈判于10月30日结束，共162个通用名药品参加谈判/竞价，包括医保目录外117种和目录内45种。 ->点击阅读原文，解锁完整双语新闻 No.2 / 国家药监局同意10省市开展优化药品补充申请审评程序改革试点 2024年11月22日，国家药监局发布通知，同意北京、天津、河北、上海、江苏、浙江、山东、广东、重庆、四川10省市开展优化药品补充申请审评审批程序改革试点。 2024年2月，国家药监局制定《优化药品补充申请审评审批程序改革试点工作方案》，以提升药品审评审批效能。2024年4月，北京市医保局发布的《北京市支持创新医药高质量发展若干措施（2024）（征求意见稿）》要求，推动实施“药品补充申请审评时限从200日压缩至60日的国家创新试点。2024年8月，上海市人民政府发布的《关于支持生物医药产业全链条创新发展的若干意见》要求，将药品补充申请审评时限压缩至60个工作日。 ->点击阅读原文，解锁完整双语新闻 全球医疗情报领导者 解锁隐藏在数据中的商业潜力  关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。 联系我们 投稿 | 发稿 | 媒体合作 ▶ hezheng@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写 点击阅读原文，解锁完整双语新闻

Acquisition to expand interventional oncology offerings with complementary therapy to treat liver-dominant metastases MARLBOROUGH, Mass., Nov. 25, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Intera Oncology® Inc., a privately held medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine – a chemotherapy drug – both of which are approved by the U.S. Food and Drug Administration. The Intera 3000 pump is used to administer hepatic artery infusion (HAI) therapy to treat tumors in the liver primarily caused by metastatic colorectal cancer. There are approximately 1.4 million people in the U.S. living with primary colorectal cancer, and more than 150,000 new cases are diagnosed each year.i For nearly 25% of these patients, the cancer will spread to the liver during their illness.ii In patients who receive HAI therapy to treat their cancer, the Intera 3000 pump is implanted under the skin and a connected catheter is placed in the hepatic artery, which supplies the liver with oxygenated blood. The pump then provides a continuous flow of floxuridine directly into the liver to treat tumors that have metastasized, most commonly from the colon. "Liver cancer is a leading cause of cancer-related death, and we are committed to providing meaningful solutions to safely and effectively treat various forms of this disease with minimal systemic side effects and improved outcomes for patients," said Peter Pattison, president, Interventional Oncology and Embolization, Boston Scientific. "Interest in HAI therapy has grown in the oncology community given improved techniques, positive clinical results and ongoing trials. We believe this acquisition will enable us to provide a more comprehensive set of solutions to physicians and their patients to treat both primary and metastatic forms of liver cancer." The Intera 3000 pump is the only constant flow implantable pump for HAI therapy approved in the United States. The safety and effectiveness of the Intera 3000 pump is supported by data from randomized controlled trials demonstrating the clinical benefits of HAI therapy for patients with unresectable colorectal metastases to the liver, both prior to and following resection. Data from these trials have highlighted that HAI therapy significantly improves tumor response, time to progression and overall survival compared to systemic chemotherapy,iii,iv,v and that combining HAI with systemic chemotherapy may lead to extended survival and higher conversion-to-resection rates in both chemotherapy-naïve and previously treated patients.vi,vii Current Phase II and III studies are exploring HAI therapy use in larger patient groups for first-line, second-line and post-surgery adjuvant treatments. Boston Scientific expects to complete the transaction in the first half of 2025, subject to closing conditions. The transaction is expected to have an immaterial impact on adjusted earnings per share in 2025 and is expected to be more dilutive on a GAAP basis due to acquisition-related net charges and amortization expense. Specific terms of the transaction have not been disclosed. About Boston Scientific Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and connect on LinkedIn and X, formerly Twitter. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, the financial and business impact of the transaction and the anticipated benefits of the transaction, the closing of the transaction and the timing thereof, and product performance and impact. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the forward-looking statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Factors that may cause such differences include, among other things: future economic, political, competitive, reimbursement and regulatory conditions; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; market competition for our products; expected procedural volumes; new product introductions; demographic trends; the closing and integration of acquisitions, including our ability to achieve the anticipated benefits of the proposed transaction and successfully integrate Intera's operations; business disruptions (including disruptions in relationships with employees, customers and suppliers) following the announcement and/or closing of the proposed transaction; intellectual property; litigation; financial market conditions; future business decisions made by us and our competitors; the conditions to the completion of the proposed transaction, including the receipt of any required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; and the closing of the proposed transaction may not occur or may be delayed. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this press release. CONTACTS: Blake Rouhani Media Relations +1 (763) 494-2268 [email protected] Jon Monson Investor Relations +1 (508) 683-5450 [email protected] i Colorectal Cancer — Cancer Stat Facts ii Colorectal liver metastases: Current management and future perspectives - PMC iii Perioperative Hepatic Arterial Infusion Pump Chemotherapy Is Associated With Longer Survival After Resection of Colorectal Liver Metastases: A Propensity Score Analysis - PubMed iv Hepatic Arterial Infusion in Combination with Modern Systemic Chemotherapy is Associated with Improved Survival Compared with Modern Systemic Chemotherapy Alone in Patients with Isolated Unresectable Colorectal Liver Metastases: A Case-Control Study - PubMed v Hepatic arterial infusion versus systemic therapy for hepatic metastases from colorectal cancer: a randomized trial of efficacy, quality of life, and molecular markers (CALGB 9481) - PubMed vi Prospective phase II trial of combination hepatic artery infusion and systemic chemotherapy for unresectable colorectal liver metastases: Long term results and curative potential - PubMed vii ASO Visual Abstract: Combined Hepatic Artery Infusion Pump and Systemic Chemotherapy in the Modern Era for Chemotherapy-Naive Patients with Unresectable Colorectal Liver Metastases | Annals of Surgical Oncology SOURCE Boston Scientific Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED