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9月24日周四
  1. Servier8

    准备好参加在罗马举行的#EANO2026了吗🇮🇹? 9月24-27日,欢迎到#1展位与施维雅团队见面,并参加我们的科学研讨会。我们致力于推动肿瘤学创新,开发针对胶质瘤、胆管癌和结直肠癌等癌症的靶向疗法。我们近70%的研发投入用于支持肿瘤学研究。 了解更多:https://f.mtr.cool/fqj4sustzh @EANOassociation #EANO2026 #NeuroOncology #Oncology #CancerResearch #RareCancers #Innovation #PatientsFirst

  2. HHS13

    在特朗普总统的领导下,@VP Vance 的 @WHFraudTF 正在赢得反欺诈之战: ✅ 取消 760,000 份欺诈性奥巴马医保参保 ✅ 为纳税人节省 2.2 亿美元

    引用Dr. Oz CMS@DrOzCMS

    CMS, along with @VP Vance's @WHFraudTF team, is taking concrete and strict action against those who defraud the American taxpayer. We're also ensuring our healthcare systems are protected — here's how: ➡️ We are preventing fraudulent and improper enrollments upfront. ➡️ We are removing existing unauthorized enrollments from the system and holding brokers accountable. ➡️ We are enforcing CMS regulations governing agents and brokers.

  3. Adam Feuerstein ✡️17

    这里需要做一个重要澄清,因为下面那条讽刺性的推文对 Weave Bio 不公平。一些非常知名的制药公司已经成功使用 Weave 的 AI 平台来协助监管申报。 我的观点——说得比较笨拙——是:再多的 AI 润色,无论多聪明,也无法让一款无效的药物变得有效,比如 Annovis 正在为阿尔茨海默病开发的那款药。我知道这一点,因为我关于这款药写的报道可能比任何其他记者都多。

    引用Adam Feuerstein ✡️@adamfeuerstein

    We're breaking entirely new ground here, folks: The first AI slop New Drug Application is coming soon to the FDA. https://www.annovisbio.com/press-release-detail?i=170212

  4. HHS52

    美国卫生与公众服务部(HHS)在 X 上表示,FDA 提前数月批准了一款胰腺癌疗法,生存期较化疗翻倍。该帖引用 @FDA 的内容称,这是特朗普政府兑现加快审批、增加治愈手段承诺的体现,并附有《华盛顿观察家报》相关评论文章链接。HHS 正文称在总统领导下 FDA 正在变革癌症治疗,并引导读者查看 @FDA_KyleD 的更多内容。

    引用U.S. FDA@FDA

    The Trump administration is delivering on its promise: faster approvals, more cures, stronger American biotech. The FDA approved a treatment for pancreatic cancer months ahead of schedule — doubling survival vs. chemo. https://www.washingtonexaminer.com/op-eds/4733623/pancreatic-cancer-fda-approval-rasonque-daraxonrasib-trump/

  5. MHRA (英国药监)62

    MHRA 批准 lurbinectedin 联合阿替利珠单抗用于广泛期小细胞肺癌维持治疗

    MHRA 于 2026 年 9 月 23 日批准 lurbinectedin(Zepzelca)与阿替利珠单抗联用,用于一线阿替利珠单抗、卡铂和依托泊苷诱导治疗后未进展的广泛期小细胞肺癌成人患者的维持治疗。

    推荐理由:原文给出该药与阿替利珠单抗联用维持治疗的总生存期与无进展生存期数据,可据此判断其对广泛期小细胞肺癌二线维持治疗格局的影响。

9月23日周三
  1. Matthew Herper62

    Matthew Herper 在 X 上实时记录 FDA 顾问委员会对 Grail($GRAL)Galleri 多癌种血液检测的讨论。会上目前仅有公司方陈述,Grail 强调该检测能发现更多癌症并可定位,但未涉及对患者获益的更大问题;多位委员提出质疑,包括这种对医生的服务能否规模化,以及“有治愈意图但缺乏结局数据”。有委员追问为何 Grail 英国随机临床试验的对照组和主要终点未纳入简报文件,Grail 与 FDA 称这是双方协议所致;另有委员追问为何 Grail 另一项大型研究的许多患者未被纳入,Grail 称与数据提交时间有关。FDA 官员表示随访和结局数据超出本次所审评声称的范围。

    引用Matthew Herper@matthewherper

    I’m following the FDA advisory committee on $GRAL’s Galleri blood test for detecting multiple types of cancer today and will be posting my thoughts here. So far, we’ve seen only company presentations, usually the dullest part of an advisory panel. But there have been some interesting tidbits. First, Grail is leaning heavily into simply the idea that they detect more cancers and can localize them, not getting into larger questions about the benefit to patients from doing so. See this slide. Speaking as part of Grail’s presentation, Mylynda Massart, a family medicine at UPMC, argued that the test can fit will with existing cancer screening and is something that many patients are eager to use. The panelists, in their first questions, expressed skepticism. One asked if the incredible, white-glove treatment that Grail gives doctors now can really scale. Another responded a Grail comment: “You’re carefully choosing your words. It is curative intent but you do not have outcome data.” Another panelist asked why the control arm of Grail’s randomized clinical trial in the UK was not included in the briefing document; the primary outcome of that trial was not included, either. Grail and FDA said that based on the agreement they came to with the FDA. Another panelist asked why so many patients from Grail’s other big study were not included in the briefing material; Grail said that had to do with when the data were submitted. What’s interesting is that the FDA seems to be telling the panel to limit the scope of its discussion. An FDA official said that both follow-ups and outcome data were beyond the scope of the claim being considered.

    推荐理由:FDA 顾问委员会对 Galleri 多癌种血液检测的讨论,呈现审评中对结局数据与检测获益的分歧。

  2. Matthew Herper62

    记者 Matthew Herper 在 X 上实时记录 FDA 专家委员会对 Grail($GRAL)Galleri 多癌种血液检测的审议。目前仅公司方陈述,Grail 强调检测能发现更多癌症并定位,未深入讨论患者获益;UPMC 家庭医学医生 Mylynda Massart 称该检测可融入现有癌症筛查。

    推荐理由:记录 FDA 专家委员会对 Galleri 多癌种早筛检测的现场质疑,呈现审评焦点与证据缺口。

  3. MedCity News12

    肿瘤创新:新老药物联用的协同效应

    Genelux Corporation 首席医学官 Jason Litten 提出,实体瘤治疗的关键在于将新老疗法合理联用,而非依赖单一高工程化药物。其思路是用溶瘤病毒感染肿瘤并释放肿瘤抗原以激活免疫系统,再叠加铂类化疗,形成“prime-boost”效应,从而克服铂类耐药。他还看好人工智能用于临床前建模,并主张在更早治疗线次探索联合疗法。