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JoshuaLiew
2021-12-16

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Biogen plans to submit final design of Aduhelm confirmatory trial to FDA in March<blockquote>Biogen计划在3月份向FDA提交Aduhelm确认性试验的最终设计</blockquote>

Biogen Inc said on Thursday it was expecting to submit a final design for a post-marketing confirmat

Biogen plans to submit final design of Aduhelm confirmatory trial to FDA in March<blockquote>Biogen计划在3月份向FDA提交Aduhelm确认性试验的最终设计</blockquote>

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color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nBiogen plans to submit final design of Aduhelm confirmatory trial to FDA in March<blockquote>Biogen计划在3月份向FDA提交Aduhelm确认性试验的最终设计</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">Reuters</strong><span class=\"h-time small\">2021-12-16 20:17</span>\n</p>\n</h4>\n</header>\n<article>\n<p>Biogen Inc said on Thursday it was expecting to submit a final design for a post-marketing confirmatory study of its newly approved Alzheimer's drug, Aduhelm, to the U.S. Food and Drug Administration in March, and begin screening of patients in May.</p><p><blockquote>百健公司周四表示，预计将向美国提交其新批准的阿尔茨海默氏症药物 Aduhelm 的上市后验证性研究的最终设计。食品药品监督管理局将于3月开始对患者进行筛查，并于5月开始对患者进行筛查。</blockquote></p><p> Aduhelm, the first new treatment for the memory-robbing disease in nearly 20 years, is battling slow uptake as experts have questioned the FDA's rationale for clearing the drug without more definitive proof of benefit.</p><p><blockquote>Aduhelm 是近 20 年来第一种治疗这种记忆剥夺疾病的新疗法，目前正在与缓慢的吸收作斗争，因为专家们质疑 FDA 在没有更明确的益处证据的情况下批准该药物的理由。</blockquote></p><p> The drug was approved in June using the FDA's accelerated approval pathway, under which Biogen is required to conduct a confirmatory clinical trial to demonstrate the drug works as intended, but has several years to do so.</p><p><blockquote>该药物于 6 月使用 FDA 的加速批准途径获得批准，根据该途径，百健需要进行一项确认性临床试验，以证明该药物按预期发挥作用，但有几年的时间来完成。</blockquote></p><p> Biogen said it anticipates the&nbsp;primary completion date to be about four years after the study begins, ahead of the FDA's nine-year requirement.</p><p><blockquote>百健表示，预计主要完成日期将在研究开始后约四年，领先于 FDA 九年的要求。</blockquote></p><p> The study will be a&nbsp;global trial with more than 1,300 early Alzheimer's disease patients.</p><p><blockquote>这项研究将是一项全球性试验，涉及1300多名早期阿尔茨海默病患者。</blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"https://finance.yahoo.com/news/biogen-plans-submit-final-design-120750376.html\">Reuters</a></p>\n<p>为提升您的阅读体验，我们对本页面进行了排版优化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BIIB":"渤健公司"},"source_url":"https://finance.yahoo.com/news/biogen-plans-submit-final-design-120750376.html","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1131517493","content_text":"Biogen Inc said on Thursday it was expecting to submit a final design for a post-marketing confirmatory study of its newly approved Alzheimer's drug, Aduhelm, to the U.S. Food and Drug Administration in March, and begin screening of patients in May.\nAduhelm, the first new treatment for the memory-robbing disease in nearly 20 years, is battling slow uptake as experts have questioned the FDA's rationale for clearing the drug without more definitive proof of benefit.\nThe drug was approved in June using the FDA's accelerated approval pathway, under which Biogen is required to conduct a confirmatory clinical trial to demonstrate the drug works as intended, but has several years to do so.\nBiogen said it anticipates the primary completion date to be about four years after the study begins, ahead of the FDA's nine-year requirement.\nThe study will be a global trial with more than 1,300 early Alzheimer's disease patients.","news_type":1,"symbols_score_info":{"BIIB":0.9}},"isVote":1,"tweetType":1,"viewCount":3753,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":8,"subscribersOnly":false,"subscribersOnlyAccessible":false,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"hasMoreComment":false,"orderType":2}