由於諾和諾德的生產問題，FDA對再生元Eylea HD的決定被推遲FDA Decision on Regeneron’s Eylea HD Delayed Due to Novo Nordisk Manufacturing Issues

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08/21

by Mark Chiang

馬克·江

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The U.S. Food and Drug Administration (FDA) has postponed its decision on Eylea HD, a high-dose formulation of the eye treatment developed by Regeneron Pharmaceuticals. The delay stems from manufacturing issues at a facility operated by Novo Nordisk, which is involved in the production process for the drug.

美國食品和藥物管理局（FDA）推遲了對再生元製藥公司開發的眼科治療藥物高劑量配方Eylea HD的決定。此次延遲源於諾和諾德運營的一家工廠在該藥物生產過程中出現的製造問題。

Regeneron had anticipated this setback, according to statements from the company..

根據該公司的聲明，再生元公司已經預料到這一挫折。

The FDA’s revised timeline for action on Eylea HD remains unclear as it works to address concerns related to Novo Nordisk’s facility. The manufacturing site in question plays a critical role in producing components for the high-dose version of Eylea, which is designed to treat retinal diseases such as age-related macular degeneration and diabetic retinopathy.

FDA針對Eylea HD採取行動的修訂時間表仍不明確，因其正努力解決與諾和諾德設施相關的問題。備受關注的生產場地在爲高劑量版Eylea生產組件方面發揮着關鍵作用，該藥物旨在治療視網膜疾病，例如年齡相關性黃斑變性和糖尿病視網膜病變。

Regeneron has not disclosed further details about the specific issues at Novo Nordisk’s facility but stated that it continues to work closely with both Novo and the FDA to resolve the matter..

再生元並未透露諾和諾德工廠具體問題的更多細節，但表示將繼續與諾和以及FDA密切合作以解決此事。

Newsflash | Powered by GeneOnline AI

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Source: GO-AI-ne1

來源：GO-AI-ne1

Date: August 21, 2025

日期：2025年8月21日

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Catalent to Cut 350 Jobs at Baltimore Gene Therapy Facility Amid Operational Streamlining Efforts

Catalent將在巴爾的摩基因治療設施裁員350人，作爲運營精簡努力的一部分。

2025-08-21

2025年8月21日

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The delay stems from manufacturing issues at a facility operated by <a href=\"https://laohu8.com/S/NVO\">Novo Nordisk</a>, which is involved in the production process for the drug.</p><p><a href=\"https://laohu8.com/S/USFD\">美國食品</a>和藥物管理局（FDA）推遲了對<a href=\"https://laohu8.com/S/REGN\">再生元製藥公司</a>開發的眼科治療藥物高劑量配方Eylea HD的決定。此次延遲源於諾和諾德運營的一家工廠在該藥物生產過程中出現的製造問題。</p><p>Regeneron had anticipated this setback, according to statements from the company..</p><p>根據該公司的聲明，再生元公司已經預料到這一挫折。</p><p>The FDA’s revised timeline for action on Eylea HD remains unclear as it works to address concerns related to Novo Nordisk’s facility. 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Collaborate with us:</p><p>©www.geneonline.com 版權所有。與我們合作：</p><p>[email protected]</p><p>電子郵件地址</p><p>Author</p><p>作者</p><p>Mark Chiang</p><p>馬克·蔣</p><p>Related Post</p><p>相關文章</p><p>News Flash</p><p>新聞快訊</p><p><a href=\"https://laohu8.com/S/CTLT\">Catalent</a> to Cut 350 Jobs at Baltimore Gene Therapy Facility Amid Operational Streamlining Efforts</p><p>Catalent將在巴爾的摩基因治療設施裁員350人，作爲運營精簡努力的一部分。</p><p>2025-08-21</p><p>2025年8月21日</p></article></body></html>","source":"tencent","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>由於諾和諾德的生產問題，FDA對再生元Eylea HD的決定被推遲FDA Decision on Regeneron’s Eylea HD Delayed Due to Novo Nordisk Manufacturing Issues</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\">\n由於諾和諾德的生產問題，FDA對再生元Eylea HD的決定被推遲FDA Decision on Regeneron’s Eylea HD Delayed Due to Novo Nordisk Manufacturing Issues\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">動脈網</strong><span class=\"h-time small\">2025-08-21 20:04</span>\n</p>\n</h4>\n</header>\n<article>\n<html><body><article><p>by Mark Chiang</p><p>馬克·江</p><p>Share To</p><p>分享到</p><p>The U.S. Food and Drug Administration (FDA) has postponed its decision on Eylea HD, a high-dose formulation of the eye treatment developed by Regeneron Pharmaceuticals. The delay stems from manufacturing issues at a facility operated by <a href=\"https://laohu8.com/S/NVO\">Novo Nordisk</a>, which is involved in the production process for the drug.</p><p><a href=\"https://laohu8.com/S/USFD\">美國食品</a>和藥物管理局（FDA）推遲了對<a href=\"https://laohu8.com/S/REGN\">再生元製藥公司</a>開發的眼科治療藥物高劑量配方Eylea HD的決定。此次延遲源於諾和諾德運營的一家工廠在該藥物生產過程中出現的製造問題。</p><p>Regeneron had anticipated this setback, according to statements from the company..</p><p>根據該公司的聲明，再生元公司已經預料到這一挫折。</p><p>The FDA’s revised timeline for action on Eylea HD remains unclear as it works to address concerns related to Novo Nordisk’s facility. The manufacturing site in question plays a critical role in producing components for the high-dose version of Eylea, which is designed to treat retinal diseases such as age-related macular degeneration and diabetic retinopathy.</p><p>FDA針對Eylea HD採取行動的修訂時間表仍不明確，因其正努力解決與諾和諾德設施相關的問題。備受關注的生產場地在爲高劑量版Eylea生產組件方面發揮着關鍵作用，該藥物旨在治療視網膜疾病，例如年齡相關性黃斑變性和糖尿病視網膜病變。</p><p>Regeneron has not disclosed further details about the specific issues at Novo Nordisk’s facility but stated that it continues to work closely with both Novo and the FDA to resolve the matter..</p><p>再生元並未透露諾和諾德工廠具體問題的更多細節，但表示將繼續與諾和以及FDA密切合作以解決此事。</p><p>Newsflash | Powered by GeneOnline AI</p><p>新聞快訊 | 由GeneOnline AI提供支持</p><p>Source: GO-AI-ne1</p><p>來源：GO-AI-ne1</p><p>Date: August 21, 2025</p><p>日期：2025年8月21日</p><p>Related posts:</p><p>相關內容：</p><p>Generic Drug Production Focuses on Quality Amidst Rise in Manufacturers</p><p>仿製藥生產在製造商增多的情況下注重質量</p><p>Bristol Myers Squibb Schizophrenia Drug Fails to Show Added Benefit in Trial as Adjunct Therapy</p><p>百時美<a href=\"https://laohu8.com/S/BMY\">施貴寶</a>精神分裂症藥物在輔助治療試驗中未能顯示額外益處</p><p>Gut Metabolic Disruptions Linked to Chronic Inflammatory Bowel Diseases</p><p>腸道代謝紊亂與慢性炎症性腸病有關</p><p>Study Links Smartphone Ownership Before Age 13 to Poorer Mental <a href=\"https://laohu8.com/S/HIT\">Health in</a> Adulthood</p><p>研究發現：13歲前擁有智能手機與成年後心理健康狀況較差有關</p><p>©www.geneonline.com All rights reserved. Collaborate with us:</p><p>©www.geneonline.com 版權所有。與我們合作：</p><p>[email protected]</p><p>電子郵件地址</p><p>Author</p><p>作者</p><p>Mark Chiang</p><p>馬克·蔣</p><p>Related Post</p><p>相關文章</p><p>News Flash</p><p>新聞快訊</p><p><a href=\"https://laohu8.com/S/CTLT\">Catalent</a> to Cut 350 Jobs at Baltimore Gene Therapy Facility Amid Operational Streamlining Efforts</p><p>Catalent將在巴爾的摩基因治療設施裁員350人，作爲運營精簡努力的一部分。</p><p>2025-08-21</p><p>2025年8月21日</p></article></body></html>\n<div class=\"bt-text\">\n\n\n<p> 來源：<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250821200614975672cd&s=b\">動脈網</a></p>\n<p>為提升您的閱讀體驗，我們對本頁面進行了排版優化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0820561818.USD","symbol_name":"安聯收益及增長平衡基金Cl AM DIS","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250821200614975672cd&s=b","article_id":"2561677624","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250821200614975672cd&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2561677624","pubTimestamp":1755777840,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"by Mark Chiang馬克·江Share To分享到The U.S. Food and Drug Administration  has postponed its decision on Eylea HD, a high-dose formulation of the eye treatment developed by Regeneron Pharmaceuticals. The delay stems from manufacturing issues at a facility operated by Novo Nordisk, which is involved in the production process for the drug.美國食品和藥物管理局推遲了對再生元製藥公司開發的眼科治療藥物高劑量配方Eylea HD的決定。The FDA’s revised timeline for action on Eylea HD remains unclear as it works to address concerns related to Novo Nordisk’s facility. The manufacturing site in question plays a critical role in producing components for the high-dose version of Eylea, which is designed to treat retinal diseases such as age-related macular degeneration and diabetic retinopathy.FDA針對Eylea HD採取行動的修訂時間表仍不明確，因其正努力解決與諾和諾德設施相關的問題。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU0820561818.USD":"安联收益及增长平衡基金Cl AM DIS","LU0942090050.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD)  INC","LU2756315664.SGD":"ALLIANZ INCOME AND GROWTH \"AMI\" (SGDHDG) INC","LU0823411888.USD":"法巴消费创新基金 Cap","LU0079474960.USD":"联博美国增长基金A","BK4581":"高盛持仓","NVO":"诺和诺德","BK4532":"文艺复兴科技持仓","LU1551013342.USD":"Allianz Income and Growth Cl AMg2 DIS USD","BK4599":"减肥药","LU1162221912.USD":"FRANKLIN INCOME \"A\" (USD) ACC","IE00B1XK9C88.USD":"PINEBRIDGE US LARGE CAP RESEARCH ENHANCED \"A\" (USD) ACC","LU0689472784.USD":"安联收益及增长基金Cl AM AT Acc","LU0868494708.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) INC","BK4585":"ETF&股票定投概念","BK4534":"瑞士信贷持仓","BK4567":"ESG概念","LU1929549753.HKD":"FRANKLIN INCOME \"A\" (HKD) INC","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","LU0234572021.USD":"高盛美国核心股票组合Acc","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","LU0820562030.AUD":"ALLIANZ INCOME AND GROWTH \"AMH2\" (AUDHDG) H2 INC","BK4083":"家庭装潢零售","BK4566":"资本集团","LU1069344957.HKD":"AB SICAV I - AMERICAN GROWTH PORTFOLIO \"AD\" (HKD) INC","LU0354030511.USD":"ALLSPRING  U.S. LARGE CAP GROWTH \"I\" (USD) ACC","LU0823434740.USD":"BNP PARIBAS US GROWTH \"C\" (USD) INC","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","LU0354030438.USD":"富国美国大盘成长基金Cl A Acc","LU1551013425.SGD":"Allianz Income and Growth Cl AMg2 DIS H2-SGD","LU1989772840.SGD":"CPR Invest - Climate Action A2 Acc SGD-H","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","BK4504":"桥水持仓","LU1496350171.SGD":"FRANKLIN DIVERSIFIED BALANCED \"A\" (SGDHDG) ACC","LU1035775433.USD":"AB SICAV I - AMERICAN GROWTH PORTFOLIO \"AD\" (USD) INC","LU1989772923.USD":"CPR Invest - Climate Action A2 Acc USD-H","LU2756315318.SGD":"ALLIANZ INCOME AND GROWTH \"AMG\" (SGDHDG) INC A","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","LU1496350502.SGD":"FRANKLIN DIVERSIFIED DYNAMIC \"A\" (SGDHDG) ACC","BK4588":"碎股","BK4550":"红杉资本持仓","LU1674673691.USD":"HSBC GIF GLOBAL LOWER CARBON EQUITY \"AD\" (USD) INC","HD":"家得宝","LU1914381329.SGD":"Allianz Best Styles Global Equity Cl ET Acc H2-SGD","LU0820561909.HKD":"ALLIANZ INCOME AND GROWTH \"AM\" (HKD) INC","LU0238689110.USD":"贝莱德环球动力股票基金","LU1674673428.USD":"HSBC GIF GLOBAL LOWER CARBON EQUITY \"AC\" (USD) ACC","BK4007":"制药"},"translate_title":"FDA decision on Regeneron Eylea HD delayed due to production issues at Novo Nordisk FDA Decision on Regeneron's Eylea HD Delayed Due to Novo Nordisk Manufacturing Issues","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"HD":1,"NVO":1},"content_text":"by Mark Chiang馬克·江Share To分享到The U.S. Food and Drug Administration (FDA) has postponed its decision on Eylea HD, a high-dose formulation of the eye treatment developed by Regeneron Pharmaceuticals. The delay stems from manufacturing issues at a facility operated by Novo Nordisk, which is involved in the production process for the drug.美國食品和藥物管理局（FDA）推遲了對再生元製藥公司開發的眼科治療藥物高劑量配方Eylea HD的決定。此次延遲源於諾和諾德運營的一家工廠在該藥物生產過程中出現的製造問題。Regeneron had anticipated this setback, according to statements from the company..根據該公司的聲明，再生元公司已經預料到這一挫折。The FDA’s revised timeline for action on Eylea HD remains unclear as it works to address concerns related to Novo Nordisk’s facility. The manufacturing site in question plays a critical role in producing components for the high-dose version of Eylea, which is designed to treat retinal diseases such as age-related macular degeneration and diabetic retinopathy.FDA針對Eylea HD採取行動的修訂時間表仍不明確，因其正努力解決與諾和諾德設施相關的問題。備受關注的生產場地在為高劑量版Eylea生產組件方面發揮着關鍵作用，該藥物旨在治療視網膜疾病，例如年齡相關性黃斑變性和糖尿病視網膜病變。Regeneron has not disclosed further details about the specific issues at Novo Nordisk’s facility but stated that it continues to work closely with both Novo and the FDA to resolve the matter..再生元並未透露諾和諾德工廠具體問題的更多細節，但表示將繼續與諾和以及FDA密切合作以解決此事。Newsflash | Powered by GeneOnline AI新聞快訊 | 由GeneOnline AI提供支持Source: GO-AI-ne1來源：GO-AI-ne1Date: August 21, 2025日期：2025年8月21日Related posts:相關內容：Generic Drug Production Focuses on Quality Amidst Rise in Manufacturers仿製藥生產在製造商增多的情況下注重質量Bristol Myers Squibb Schizophrenia Drug Fails to Show Added Benefit in Trial as Adjunct Therapy百時美施貴寶精神分裂症藥物在輔助治療試驗中未能顯示額外益處Gut Metabolic Disruptions Linked to Chronic Inflammatory Bowel Diseases腸道代謝紊亂與慢性炎症性腸病有關Study Links Smartphone Ownership Before Age 13 to Poorer Mental Health in Adulthood研究發現：13歲前擁有智能手機與成年後心理健康狀況較差有關©www.geneonline.com All rights reserved. Collaborate with us:©www.geneonline.com 版權所有。與我們合作：[email protected]電子郵件地址Author作者Mark Chiang馬克·蔣Related Post相關文章News Flash新聞快訊Catalent to Cut 350 Jobs at Baltimore Gene Therapy Facility Amid Operational Streamlining EffortsCatalent將在巴爾的摩基因治療設施裁員350人，作為運營精簡努力的一部分。2025-08-212025年8月21日","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}