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2021-07-06
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U.S. FDA declines to approve Provention Bio's diabetes drug<blockquote>美国FDA拒绝批准Provention Bio的糖尿病药物</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\">\nU.S. FDA declines to approve Provention Bio's diabetes drug<blockquote>美国FDA拒绝批准Provention Bio的糖尿病药物</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">Reuters</strong><span class=\"h-time small\">2021-07-06 19:28</span>\n</p>\n</h4>\n</header>\n<article>\n<p>(Reuters) -The U.S. Food and Drug Administration on Tuesday declined to approve Provention Bio Inc’s experimental diabetes drug teplizumab, citing insufficient data, the company said on Tuesday.</p><p><blockquote>（路透社）-美国。Provention Bio Inc.周二表示，美国食品和药物管理局周二拒绝批准该公司的实验性糖尿病药物teplizumab，理由是数据不足。</blockquote></p><p> The health regulator said a study in healthy volunteers to compare planned commercial product with the drug product used in the company’s clinical trials had failed to show comparability.</p><p><blockquote>卫生监管机构表示，一项在健康志愿者中进行的将计划的商业产品与该公司临床试验中使用的药品进行比较的研究未能显示出可比性。</blockquote></p><p> The agency asked the company to establish comparability between the two products or provide other data that adequately justifies why it would not be necessary, Provention Bio said.</p><p><blockquote>Provention Bio表示，该机构要求该公司建立这两种产品之间的可比性，或提供其他数据，充分证明为什么没有必要这样做。</blockquote></p><p> It also cited deficiencies related to a recent inspection at a manufacturing plant used by the company.</p><p><blockquote>它还列举了与该公司使用的一家制造工厂最近的检查相关的缺陷。</blockquote></p><p> The company expects to collect the additional comparability data from a sub-study of the drug, intended for the delay of clinical type 1 diabetes, later this quarter.</p><p><blockquote>该公司预计将在本季度晚些时候从该药物的子研究中收集额外的可比性数据，该药物旨在延缓临床1型糖尿病。</blockquote></p><p> Trading in shares of Provention Bio were halted.</p><p><blockquote>Provention Bio的股票交易暂停。</blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"https://www.reuters.com/article/provention-fda/update-1-u-s-fda-declines-to-approve-provention-bios-diabetes-drug-idUSL3N2OI2NC\">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":{"PRVB":"Provention Bio, Inc"},"source_url":"https://www.reuters.com/article/provention-fda/update-1-u-s-fda-declines-to-approve-provention-bios-diabetes-drug-idUSL3N2OI2NC","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1164032536","content_text":"(Reuters) -The U.S. Food and Drug Administration on Tuesday declined to approve Provention Bio Inc’s experimental diabetes drug teplizumab, citing insufficient data, the company said on Tuesday.\nThe health regulator said a study in healthy volunteers to compare planned commercial product with the drug product used in the company’s clinical trials had failed to show comparability.\nThe agency asked the company to establish comparability between the two products or provide other data that adequately justifies why it would not be necessary, Provention Bio said.\nIt also cited deficiencies related to a recent inspection at a manufacturing plant used by the company.\nThe company expects to collect the additional comparability data from a sub-study of the drug, intended for the delay of clinical type 1 diabetes, later this quarter.\nTrading in shares of Provention Bio were halted.","news_type":1,"symbols_score_info":{"PRVB":0.9}},"isVote":1,"tweetType":1,"viewCount":697,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"EN","currentLanguage":"EN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":6,"xxTargetLangEnum":"ORIG"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/157182587"}
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