Biogen plans to submit final design of Aduhelm confirmatory trial to FDA in March

Reuters2021-12-16

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 ...

网页链接

免责声明：本文观点仅代表作者个人观点，不构成本平台的投资建议，本平台不对文章信息准确性、完整性和及时性做出任何保证，亦不对因使用或信赖文章信息引发的任何损失承担责任。

精彩评论

Ruby Kes
2021-12-17
Ruby Kes
Bring in the FDA and bomb everything goes up.
TradeMore
2021-12-16
TradeMore
Ok
JoshuaLiew
2021-12-16
JoshuaLiew
Ok can can
ShieYing
2021-12-16
ShieYing
Pls like
Lzoakz
2021-12-16
Lzoakz
Ok
- Lgdnic:
  Ok
- ShieYing:
  ok
- Angsana:
  ok
frusty
2021-12-16
frusty
Like
- Lzoakz:
  Ok

发表看法

{"i18n":{"language":"zh_CN"},"isChannel":false,"data":{"share":"https://www.laohu8.com/m/news/1131517493?lang=zh_CN&edition=full","thumbnail":"","is_english":true,"pubTime":"2021-12-16 20:17","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1131517493","market":"us","top_or_hot":-1,"title":"Biogen plans to submit final design of Aduhelm confirmatory trial to FDA in March","media":"Reuters","content":"<div>\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 ...</p>\n\n<a href=\"https://finance.yahoo.com/news/biogen-plans-submit-final-design-120750376.html\">网页链接</a>\n\n</div>\n","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; 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</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: 11px; color: #7E829C; margin: 0;line-height: 11px;}\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\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-12-16 20:17 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/biogen-plans-submit-final-design-120750376.html><strong>Reuters</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\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 ...</p>\n\n<a href=\"https://finance.yahoo.com/news/biogen-plans-submit-final-design-120750376.html\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BIIB","symbol_name":"渤健公司","start_time":0,"source_url":"https://finance.yahoo.com/news/biogen-plans-submit-final-design-120750376.html","article_id":"1131517493","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1131517493","pubTimestamp":1639657077,"sourceInfo":null,"weMediaInfo":null,"summary":"Biogen Inc said on Thursday it was expecting to submit a final design for a post-marketing confirmat","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BIIB":"渤健公司"},"translate_title":"Biogen计划在3月份向FDA提交Aduhelm验证试验的最终设计","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BIIB":0.9},"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.","kind":null,"is_publish_news":true,"is_publish_highlight":true,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[{"id":690240807,"gmtCreate":1639672421614,"gmtModify":1639672480606,"author":{"id":"4100175353005890","authorId":"4100175353005890","name":"Ruby Kes","avatar":"https://static.tigerbbs.com/648b48c5edc2e1a041df890be5c682f8","vip":1,"crmLevel":2,"crmLevelSwitch":0,"idStr":"4100175353005890","authorIdStr":"4100175353005890"},"htmlText":"Bring in the FDA and bomb everything goes up.","listText":"Bring in the FDA and bomb everything goes up.","text":"Bring in the FDA and bomb everything goes up.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/690240807","repostId":1131517493,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":690282517,"gmtCreate":1639669855947,"gmtModify":1639669856170,"author":{"id":"4097720712211120","authorId":"4097720712211120","name":"TradeMore","avatar":"https://static.tigerbbs.com/976c10f5e71e9a3b002205015f764d44","vip":1,"crmLevel":2,"crmLevelSwitch":0,"idStr":"4097720712211120","authorIdStr":"4097720712211120"},"htmlText":"Ok","listText":"Ok","text":"Ok","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/690282517","repostId":1131517493,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":690683387,"gmtCreate":1639663710173,"gmtModify":1639663710386,"author":{"id":"3559194206832147","authorId":"3559194206832147","name":"JoshuaLiew","avatar":"https://static.tigerbbs.com/b503d223679dec0ab7416f6186269f11","vip":1,"crmLevel":5,"crmLevelSwitch":0,"idStr":"3559194206832147","authorIdStr":"3559194206832147"},"htmlText":"Ok can can","listText":"Ok can can","text":"Ok can can","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/690683387","repostId":1131517493,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":690845464,"gmtCreate":1639658621353,"gmtModify":1639658796714,"author":{"id":"4087711536073680","authorId":"4087711536073680","name":"ShieYing","avatar":"https://static.tigerbbs.com/77886d00fd169f3ac02d1ba4a9606206","vip":1,"crmLevel":1,"crmLevelSwitch":0,"idStr":"4087711536073680","authorIdStr":"4087711536073680"},"htmlText":"Pls like","listText":"Pls like","text":"Pls like","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/690845464","repostId":1131517493,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":690851389,"gmtCreate":1639657339084,"gmtModify":1639657339247,"author":{"id":"3571099496073631","authorId":"3571099496073631","name":"Lzoakz","avatar":"https://static.tigerbbs.com/1b25fe5f61dfcb3947c3347cb6e1bd6f","vip":1,"crmLevel":2,"crmLevelSwitch":0,"idStr":"3571099496073631","authorIdStr":"3571099496073631"},"htmlText":"Ok","listText":"Ok","text":"Ok","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":3,"commentSize":3,"repostSize":0,"link":"https://laohu8.com/post/690851389","repostId":1131517493,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"comments":[{"id":7006723,"gmtCreate":1639658995009,"gmtModify":1639658995045,"authorId":3584100767586786,"author":{"id":3584100767586786,"idStr":"3584100767586786","authorId":3584100767586786,"name":"Lgdnic","avatar":"https://static.tigerbbs.com/493d41d71270a52770b856ed4e663073","vip":1,"crmLevel":2,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":690851389,"type":1,"supId":7006632,"prevId":0,"content":"Ok","text":"Ok","html":"Ok"},{"id":7006632,"gmtCreate":1639658615882,"gmtModify":1639658615919,"authorId":4087711536073680,"author":{"id":4087711536073680,"idStr":"4087711536073680","authorId":4087711536073680,"name":"ShieYing","avatar":"https://static.tigerbbs.com/77886d00fd169f3ac02d1ba4a9606206","vip":1,"crmLevel":1,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":690851389,"type":1,"supId":0,"prevId":0,"content":"ok","text":"ok","html":"ok"},{"id":7006605,"gmtCreate":1639658526661,"gmtModify":1639658526760,"authorId":3575326435298567,"author":{"id":3575326435298567,"idStr":"3575326435298567","authorId":3575326435298567,"name":"Angsana","avatar":"https://static.tigerbbs.com/3c8492153d7059ec1aa704a1bd541c14","vip":1,"crmLevel":4,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":690851389,"type":1,"supId":0,"prevId":0,"content":"<u>ok</u>","text":"<u>ok</u>","html":"<u>ok</u>"}],"langContent":"CN"},{"id":690853029,"gmtCreate":1639657217465,"gmtModify":1639657217965,"author":{"id":"3555119187338975","authorId":"3555119187338975","name":"frusty","avatar":"https://static.tigerbbs.com/46c85297aaa1b07647be4b2ca33ea8e8","vip":1,"crmLevel":4,"crmLevelSwitch":0,"idStr":"3555119187338975","authorIdStr":"3555119187338975"},"htmlText":"Like","listText":"Like","text":"Like","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":3,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/690853029","repostId":1131517493,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"comments":[{"id":7006293,"gmtCreate":1639657248778,"gmtModify":1639657248869,"authorId":3571099496073631,"author":{"id":3571099496073631,"idStr":"3571099496073631","authorId":3571099496073631,"name":"Lzoakz","avatar":"https://static.tigerbbs.com/1b25fe5f61dfcb3947c3347cb6e1bd6f","vip":1,"crmLevel":2,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":690853029,"type":1,"supId":0,"prevId":0,"content":"Ok","text":"Ok","html":"Ok"}],"langContent":"CN"}],"isCommentEnd":false,"newsSizeData":{"likeSize":41,"commentSize":6,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/1131517493"}