BERLIN & NASHVILLE, Tenn.--(BUSINESS WIRE)--Bayer and Vanderbilt University Medical Center (VUMC) today announced that they have entered a strategic five-year collaboration agreement to advance innovative therapies from target identification through Investigational New Drug (IND) application. The agreement spans across all indications currently pursued by Bayer, initially focusing on cardiovascular and kidney diseases, two therapeutic areas with significant unmet medical need. The collaboration. ...

针对流感季节重点品种药品的检查，重点查看药店治疗感冒、消炎类药品是否出现短缺情况，是否能够 全力满足消费者购药用药需求。提示药店积极应对，根据药店自身经营模式，及时补充库存，重点补充 冬季呼吸道疾病的相关药物。严格执行凭处方药销售、执业药师在岗等要求，确保药品市场稳定有序。 下一步，平谷区市场监管局将持续加大药品安全监管力度，落实监管责任，督促药店落实主体责任，加 强安全风险管控，确保人民群众用药安全。（来源：平谷市场监管） 针对医保药店的检查，执法人员重点通过三个关键环节展开：一是药品购进渠道、资质、票据情况，包 括对企业购进药品渠道、上游企业的资质核验，采购及销售票据是否齐全，票、账、货、款是否一致 等；二是落实凭处方销售处方药要求情况，包括检查企业是否伪造处方，是否不凭处方销售处方药，是 否不审核处方销售处方药等；三是网络销售情况，包括核验是否符合"线上线下一致"原则，是否按要求 审核处方，发货地址与经营地址是否一致，是否按要求配送药品等。 中国质量新闻网讯 为进一步从严从实从细做好药品安全的监管工作，营造良好经营环境，北京市平谷 区市场监管局药品和化妆品监管科对辖区内的药品经营企业进行检查。本次检查重 ...

Sun has already tied up acquisition financing in the form of bridge loans from at least three global banks — one each from Wall Street, Europe and Japan — to the tune of $10-14 billion to show its commitment to the board of Organon.The due diligence process will start shortly, following which a binding bid will be made. But being a listed company, typically these dilligences are much shorter in nature. ET was the first to report January 19 on Sun making a play for Organon. The company told the exchanges th ...

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First Trust Nasdaq Pharmaceuticals ETF (FTXH US) – Portfolio Construction MethodologyThe underlying Nasdaq US Smart Pharmaceuticals Index targets a concentrated, factor-tilted portfolio of US pharmaceutical companies. The selection universe is US-listed common stocks classified in the pharmaceuticals industry within the Nasdaq US Benchmark Index that meet Nasdaq’s standard free-float and trading-volume investability screens. From this universe, the 30 stocks with the highest three-month average daily tradin ...

Airlines stand to save a potential $580 million as travelers slim down thanks to the effects of weight-loss drugs, a new study found. Sheila Kahyaoglu, an equity analyst at Jefferies and an author of the study, says the top four U.S. airlines, American Airlines, Delta Air Lines, Southwest Airlines and United Airlines, stand to save money each year because the lessened weight will lower fuel costs."Airlines have a history of being vigilant around aircraft weight savings, from olives (pitless, of course) to p ...

French drugmaker Valneva said on Monday it has voluntarily withdrawn its application seeking standard approval of its chikungunya vaccine in the United States after the FDA suspended the shot's licens... ...

核心事件与监管进展 - 美国食品药品监督管理局授予诺华公司的在研药物ianalumab用于治疗成人干燥综合征的突破性疗法认定 [1] - 突破性疗法认定基于两项关键III期研究NEPTUNUS-1和NEPTUNUS-2的数据支持 该研究达到了主要终点 [2] - 美国食品药品监督管理局曾在2016年授予ianalumab快速通道资格 [7] - 诺华计划从2026年初开始向包括美国食品药品监督管理局在内的全球多家卫生监管机构提交ianalumab的上市申请 [3][6] 药物机制与临床数据 - Ianalumab是一种研究性单克隆抗体 具有新颖的双重作用机制 通过靶向BAFF受体耗竭B细胞 同时抑制B细胞的活化和存活 [1] - 在III期NEPTUNUS研究中 与安慰剂相比 ianalumab在降低疾病活动指数评分方面显示出具有临床意义和统计学意义的改善 [2] - Ianalumab总体耐受性良好 显示出良好的安全性特征 [3] - 在针对免疫性血小板减少症的III期VAYHIT2研究中 ianalumab联合艾曲波帕将疾病控制时间延长了45% [9] - 在VAYHIT2研究中 接受ianalumab联合艾曲波帕治疗的患者有62%在六个月内达到持续血小板应答 而安慰剂联合艾曲波帕组为39% [10] 市场潜力与竞争格局 - 如果获批 ianalumab将成为首个针对干燥综合征的靶向疗法 [3] - 干燥综合征是一种进行性、异质性风湿性自身免疫性疾病 目前尚无获批的疾病修饰疗法 [7] - 除了干燥综合征 ianalumab还在其他多种B细胞驱动的自身免疫性疾病中进行研究 包括免疫性血小板减少症、系统性红斑狼疮、狼疮性肾炎等 并在部分疾病中显示出良好的疗效和安全性 [8] - 诺华计划在2027年向卫生当局提交基于VAYHIT2研究以及正在进行的免疫性血小板减少症一线治疗试验VAYHIT1的数据 [10] 公司背景与管线整合 - Ianalumab是诺华在2024年收购MorphoSys AG后 通过合作纳入其产品管线的资产 [4] - 过去一年 诺华股价上涨了48% 而行业同期涨幅为24.1% [3]

Key Takeaways NVO stock climbed 9.1% after reports of strong first-week U.S. prescriptions for oral Wegovy.Reported data covers retail only and excludes NovoCare, implying actual early oral Wegovy sales may be higher.The FDA delayed Eli Lilly's oral GLP-1 decision to April 10, giving NVO more time to strengthen its lead.Shares of Novo Nordisk (NVO) rose 9.1% on Friday after the company reportedly recorded strong early prescription trends just one week following the early-January U.S. launch of the oral vers ...