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Dren Bio Expands Strategic Collaboration with Sanofi to Develop Next-Generation B-Cell Depletion Therapy
Businesswire· 2025-12-15 13:05
Under the terms of the agreement, Dren Bio will receive an upfront payment of $100 million and is eligible to receive up to $1.7 billion in development, regulatory, and commercial milestone payments. The companies will collaborate on discovery and preclinical development activities leveraging Dren Bio's proprietary platform. Following development candidate selection, Sanofi will assume subsequent responsibility for development, manufacturing, regulatory, and commercialization efforts. Dren Bio has the optio ...
美股前瞻 | 三大股指期货齐涨 非农与CPI本周齐袭
Sou Hu Cai Jing· 2025-12-15 12:49
盘前市场动向 1. 12月15日(周一)美股盘前,美股三大股指期货齐涨。截至发稿,道指期货涨0.47%,标普500指数期货 涨0.50%,纳指期货涨0.50%。 2. 截至发稿,德国DAX指数涨0.44%,英国富时100指数涨0.94%,法国CAC40指数涨1.13%,欧洲斯托 克50指数涨0.74%。 3. 截至发稿,WTI原油跌0.42%,报57.00美元/桶。布伦特原油跌0.41%,报60.87美元/桶。 市场消息 美联储主席候选人搅动债市,非农报告及通胀数据本周来袭。在美联储于上周再次降息25个基点之后, 市场关注点可能转向接替鲍威尔成为下一任美联储主席的人选变动。美国总统特朗普认为凯文·哈塞特 或凯文·沃什中的一人将被任命。债券市场也在感受一个与白宫更紧密结盟的鸽派美联储的可能性。本 周的经济日程也将继续消化政府停摆所积压的延迟数据,其中11月份就业报告定于周二发布,11月份 CPI数据将于周四公布。财报方面,美光科技将于周三公布季度业绩,而投资者将在周四迎来埃森哲、 耐克、联邦快递以及达登餐厅(DRI.US)的业绩报告。此外,英国、欧洲央行和日本央行本周将相继公布 利率决议。 数据风暴来袭!债市激 ...
FDA延期叠加试验失败 赛诺菲(SNY.US)多发性硬化症药物遭双重暴击
智通财经网· 2025-12-15 11:05
智通财经APP获悉,赛诺菲(SNY.US)的实验性多发性硬化症药物周一遭遇双重挫折:在美国遭遇监管延 迟,同时一项后期临床试验宣告失败。 这家法国制药商表示,美国食品药品监督管理局(FDA)对其治疗晚期多发性硬化症的药物tolebrutinib的 审批决定可能会被推迟,监管机构将在第一季度末提供进一步指引。赛诺菲股价在巴黎早盘交易中暴跌 6.4%,创下三个多月来的最大跌幅。 截至发稿,该股美股盘前跌1.97%。 雪上加霜的是,赛诺菲称,在一项针对原发性进展型多发性硬化症的后期试验中,tolebrutinib未能延迟 患者残疾的进展。 分析师约翰·墨菲表示,这双重打击可能威胁到该药物高达17亿美元的年度销售峰值。赛诺菲在开发此 药过程中一直面临障碍,试验表明其存在肝损伤风险。公司未说明FDA预期延迟的原因。该审查已于今 年9月被推迟了三个月。 墨菲及其同事米拉·班科夫斯卡娅在一份报告中写道:"美国批准延迟的原因尚不清楚,可能围绕 tolebrutinib的肝脏安全性展开,但我们最终预计该药物仍将获得批准。" 杰富瑞分析师迈克尔·洛伊希滕认为,现在否定该药物还为时过早。他指出,tolebrutinib针对的是未满 ...
Sanofi shares slide as FDA delays MS drug decision and late-stage trial disappoints
Invezz· 2025-12-15 10:48
Shares of French pharmaceutical group Sanofi fell sharply on Monday after the company flagged another delay to a US regulatory decision for its experimental multiple sclerosis drug tolebrutinib and re... ...
Todd Combs, Key Investment Manager, Just Left Berkshire Hathaway for JPMorgan Chase. Does the Shakeup Bode Well For the Stock?
The Motley Fool· 2025-12-15 10:45
Combs was the CEO of GEICO Insurance and also helped manage 10% of Berkshire's enormous equities portfolio.Earlier this year, Warren Buffett announced that he would step down as chief executive officer of Berkshire Hathaway (NYSE: BRK.A) (NYSE: BRK.B) after six decades at the helm of the company. If investors didn't think the times were changing then, they likely know now. Recently, Berkshire announced a major shake-up to its core management group. Todd Combs, who joined Berkshire in 2010 and managed a port ...
Sanofi stock slumps after two setbacks on multiple-sclerosis drug
MarketWatch· 2025-12-15 09:43
Core Viewpoint - Shares of Sanofi experienced a decline following the announcement that the U.S. regulatory review of its multiple-sclerosis drug will not be completed by the end of the year [1] Group 1: Company Updates - Sanofi's multiple-sclerosis drug is facing delays in the U.S. regulatory review process, which is now expected to extend beyond the end of the year [1] - The company also indicated that a trial for a different form of treatment is ongoing, but specific details were not provided [1]
美股异动丨赛诺菲盘前跌超4%,预计旗下重磅药物tolebrutinib的监管审查将延迟
Ge Long Hui· 2025-12-15 09:20
赛诺菲(SNY.US)盘前跌超4%,报46.65美元。消息面上,赛诺菲预计,tolebrutinib用于非复发性继发进 展型多发性硬化症(nrSPMS)的美国监管审查过程将超出此前沟通的2025年12月28日的目标行动日期, 并预计将在2026年第一季度末之前收到来自FDA的进一步指导。(格隆汇) ...
58起交易!一文看懂中国医疗器械BD的秋季节奏





思宇MedTech· 2025-12-15 08:59
Core Insights - The article highlights the acceleration of business development (BD) activities in the medical device sector from September to November 2025, with a total of 58 transactions identified across various subfields, including cardiovascular, nuclear medicine, and AI-enabled devices [2][3][4]. Group 1: Mergers and Acquisitions - Mergers and acquisitions have become a prominent form of BD, with companies leveraging capital control and product integration for rapid market positioning [7][8]. - Notable acquisitions include HeartLink's $680 million all-stock acquisition of Micro-Invasive Cardiology, enhancing its structural heart disease and rhythm management capabilities [7]. - Hua'an Zhonghui's acquisition of Bangni Medical marks its entry into the absorbable suture market, indicating a shift in surgical instrument competition towards material innovation [7]. Group 2: Strategic Collaborations - Strategic partnerships have been formed during the China International Import Expo, with companies like Shanghai Pharmaceuticals collaborating with international giants such as Boston Scientific and Medtronic to enhance their supply chain and academic promotion systems [7][8]. - The collaboration between GuoYao Medical and BDI Medical aims to deepen market penetration in the biomedicine and medical device sectors, focusing on compliance and distribution channel construction [13]. Group 3: Cross-Border Cooperation - Cross-border transactions have become more active, with foreign companies establishing local R&D and production systems in China, while domestic firms are exporting their solutions globally [9][10]. - The partnership between Trasis SA and Beijing Pait Biotechnology to establish a joint venture reflects a trend towards localized production and phased integration in the Chinese market [12]. Group 4: Ecosystem Building and Channel Expansion - The integration of supply chains and ecosystem building is a key theme, with companies focusing on collaborative agreements to enhance their market presence [11][15]. - The collaboration between Baxter and Neusoft Medical aims to create a comprehensive surgical solution by integrating their respective technologies [12]. Group 5: AI and Smart Healthcare - AI and data-driven approaches are becoming central to BD collaborations, with companies increasingly focusing on smart healthcare solutions [16][17]. - The partnership between Kefu Medical and Tencent Cloud to develop AI-powered hearing aids exemplifies the trend of integrating technology into healthcare products [21]. Group 6: Research and Diagnostic Synergy - The frequency of research-oriented collaborations is rising, indicating a shift from manufacturing-driven to research-driven industry dynamics [18][19]. - The collaboration between BGI and Infinera to enhance clinical applications of sequencing technology highlights the growing importance of research in driving innovation in the medical device sector [21].
Sanofi flags delay in FDA's decision on tolebrutinib, shares fall
Reuters· 2025-12-15 08:49
Core Viewpoint - The U.S. Food and Drug Administration's decision on Sanofi's investigative drug for multiple sclerosis is expected to be delayed until the first quarter of 2026, moving from the previously communicated date of December 28 [1] Company Summary - Sanofi is a French pharmaceutical group that is currently awaiting a decision from the U.S. FDA regarding its drug for treating multiple sclerosis [1]
Sanofi Multiple Sclerosis Drug Hit by Double Setback
WSJ· 2025-12-15 06:56
A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of the disease didn't hit its main goal. ...