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charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Biogen plans to submit final design of Aduhelm confirmatory trial to FDA in March<blockquote>Biogen计划3月向FDA提交Aduhelm验证性试验最终设计</blockquote></title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; 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3月向FDA提交Aduhelm验证性试验最终设计</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(Biogen Inc)周四表示，预计将向美国提交其新批准的阿尔茨海默病药物Aduhelm的上市后验证性研究的最终设计。食品药品监督管理局，并于5月开始筛查患者。</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年来第一种治疗记忆丧失疾病的新疗法，由于专家质疑FDA在没有更明确的益处证据的情况下批准该药物的理由，该药物正在与吸收缓慢作斗争。</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月通过FDA的加速批准途径获得批准，根据该途径，Biogen需要进行一项验证性临床试验，以证明该药物按预期发挥作用，但需要几年时间才能做到这一点。</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(Biogen)表示，预计主要完成日期为研究开始后约四年，高于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>该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":644,"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":4,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/690853029"}