masran
2021-12-21
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Gilead gained in premarket trading as European Commission approved a variation to the Conditional Marketing Authorization for Veklury.<blockquote>由于欧盟委员会批准了Veklury有条件营销授权的变更，吉利德在盘前交易中上涨。</blockquote>
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This decision follows the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), to expand the indication for Veklury on December 16.</p><p><blockquote>由于欧盟委员会批准了Veklury有条件营销授权的变更，吉利德在盘前交易中上涨。吉利德科学公司今天宣布，欧盟委员会(EC)已批准Veklury的有条件营销授权变更®（瑞德西韦）纳入不需要补充氧气且进展为严重新冠肺炎风险增加的成年人。这一决定是在欧洲药品管理局（EMA）科学委员会人用药品委员会（CHMP）于12月16日积极建议扩大Veklury的适应症之后做出的。</blockquote></p><p> \"As the rates of COVID-19 climb again and new variants like Omicron emerge, we need effective tools like Veklury to treat various stages of the disease,\" said Roger Paredes, MD, PhD, Chief Infectious Diseases Department, and IrsiCaixa AIDS Research Institute Hospital Universitari Germans Trias I Pujol Badalona, Spain. \"We can now use Veklury to help prevent high-risk patients from progressing to more severe disease, even when they do not require oxygen, as well as continue to utilize Veklury as a key tool in the treatment of severe disease. This latest approval will also help to relieve some of the pressure on healthcare systems that are already under significant strain from the burden of COVID-19.\"</p><p><blockquote>“随着COVID-19发病率再次攀升以及奥密克戎病毒等新变种的出现，我们需要像Veklury这样的有效工具来治疗该疾病的各个阶段，”传染病科主任Roger Paredes医学博士和IrsiCaixa艾滋病研究所表示。“我们现在可以使用Veklury来帮助防止高危患者进展为更严重的疾病，即使他们不需要氧气，以及继续利用Veklury作为治疗严重疾病的关键工具。这一最新批准也将有助于缓解已经因COVID-19负担而承受巨大压力的医疗保健系统的一些压力。”</blockquote></p><p> The EC’s decision is supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. In the study, no deaths were observed in either arm by Day 28. The safety profile was similar between Veklury and placebo across the variety of outpatient settings in this trial, with the most common treatment emergent adverse events (≥5%) in patients taking Veklury being nausea and headache. These data have also been shared with other regulatory agencies around the world and submitted for scientific peer-reviewed publication.</p><p><blockquote>EC的决定得到了一项3期随机、双盲、安慰剂对照试验结果的支持，该试验旨在评估静脉（IV）使用Veklury三天疗程治疗疾病进展高风险的非住院患者COVID-19的疗效和安全性。在一项对以1：1比例随机分配接受Veklury或安慰剂的562名参与者的分析中，与安慰剂（5.3%【15/283】）相比，Veklury在第28天新冠肺炎相关住院或全因死亡的复合主要终点风险降低了87%（0.7%【2/279】），具有统计学意义p=0.008。在研究中，到第28天，两组均未观察到死亡。在本试验中，Veklury和安慰剂在各种门诊环境中的安全性特征相似，服用Veklury的患者中最常见的治疗后出现的不良事件（≥5%）是恶心和头痛。这些数据还与世界各地的其他监管机构共享，并提交给科学同行评审出版物。</blockquote></p><p> This expanded indication in the EU adds to the previous Conditional Marketing Authorization of Veklury enabling the treatment of COVID-19 in adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).</p><p><blockquote>欧盟的这一扩大适应症增加了Veklury之前的有条件上市许可，使其能够治疗需要补充氧气（治疗开始时的低流量或高流量氧气或其他无创通气）的肺炎成人和青少年（12岁至18岁以下，体重至少40 kg）的COVID-19。</blockquote></p><p> \"The swift action of the European Commission is a testament to the need for effective treatments that can be used earlier in the course of disease to help people with COVID-19 across Europe,\" said Merdad Parsey, M.D., Ph.D., Chief Medical Officer, Gilead Sciences. \"As we learn more about how COVID-19 disease progresses, it is clear that an antiviral like Veklury can have a significant impact if used early in the course of disease. As the antiviral standard of care for patients hospitalized with COVID-19, we are proud of the role Veklury continues to play on the front lines of the pandemic, and we believe Veklury will now be able to help more patients decrease their time to recovery from COVID-19 in Europe.\"</p><p><blockquote>吉利德科学首席医疗官、医学博士Merdad Parsey说：“欧盟委员会的迅速行动证明了需要有效的治疗方法，这些方法可以在疾病过程的早期使用，以帮助欧洲各地的COVID-19患者。”“随着我们对COVID-19疾病如何进展的了解越来越多，很明显，如果在病程早期使用，像Veklury这样的抗病毒药物可以产生重大影响。作为COVID-19住院患者的抗病毒护理标准，我们对Veklury在大流行前线继续发挥的作用感到自豪，我们相信Veklury现在将能够帮助欧洲更多患者缩短从COVID-19中康复的时间。”</blockquote></p><p></p>","collect":0,"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>Gilead gained in premarket trading as European Commission approved a variation to the Conditional Marketing Authorization for Veklury.<blockquote>由于欧盟委员会批准了Veklury有条件营销授权的变更，吉利德在盘前交易中上涨。</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\">\nGilead gained in premarket trading as European Commission approved a variation to the Conditional Marketing Authorization for Veklury.<blockquote>由于欧盟委员会批准了Veklury有条件营销授权的变更，吉利德在盘前交易中上涨。</blockquote>\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time smaller\">2021-12-21 17:17</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>Gilead gained in premarket trading as European Commission approved a variation to the Conditional Marketing Authorization for Veklury.<img src=\"https://static.tigerbbs.com/8d011c5296c3de91e509be97faad6190\" tg-width=\"709\" tg-height=\"598\" referrerpolicy=\"no-referrer\">Gilead Sciences, Inc. today announced that the European Commission (EC) has approved a variation to the Conditional Marketing Authorization for Veklury® (remdesivir) to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19. This decision follows the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), to expand the indication for Veklury on December 16.</p><p><blockquote>由于欧盟委员会批准了Veklury有条件营销授权的变更，吉利德在盘前交易中上涨。吉利德科学公司今天宣布，欧盟委员会(EC)已批准Veklury的有条件营销授权变更®（瑞德西韦）纳入不需要补充氧气且进展为严重新冠肺炎风险增加的成年人。这一决定是在欧洲药品管理局（EMA）科学委员会人用药品委员会（CHMP）于12月16日积极建议扩大Veklury的适应症之后做出的。</blockquote></p><p> \"As the rates of COVID-19 climb again and new variants like Omicron emerge, we need effective tools like Veklury to treat various stages of the disease,\" said Roger Paredes, MD, PhD, Chief Infectious Diseases Department, and IrsiCaixa AIDS Research Institute Hospital Universitari Germans Trias I Pujol Badalona, Spain. \"We can now use Veklury to help prevent high-risk patients from progressing to more severe disease, even when they do not require oxygen, as well as continue to utilize Veklury as a key tool in the treatment of severe disease. This latest approval will also help to relieve some of the pressure on healthcare systems that are already under significant strain from the burden of COVID-19.\"</p><p><blockquote>“随着COVID-19发病率再次攀升以及奥密克戎病毒等新变种的出现，我们需要像Veklury这样的有效工具来治疗该疾病的各个阶段，”传染病科主任Roger Paredes医学博士和IrsiCaixa艾滋病研究所表示。“我们现在可以使用Veklury来帮助防止高危患者进展为更严重的疾病，即使他们不需要氧气，以及继续利用Veklury作为治疗严重疾病的关键工具。这一最新批准也将有助于缓解已经因COVID-19负担而承受巨大压力的医疗保健系统的一些压力。”</blockquote></p><p> The EC’s decision is supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. In the study, no deaths were observed in either arm by Day 28. The safety profile was similar between Veklury and placebo across the variety of outpatient settings in this trial, with the most common treatment emergent adverse events (≥5%) in patients taking Veklury being nausea and headache. These data have also been shared with other regulatory agencies around the world and submitted for scientific peer-reviewed publication.</p><p><blockquote>EC的决定得到了一项3期随机、双盲、安慰剂对照试验结果的支持，该试验旨在评估静脉（IV）使用Veklury三天疗程治疗疾病进展高风险的非住院患者COVID-19的疗效和安全性。在一项对以1：1比例随机分配接受Veklury或安慰剂的562名参与者的分析中，与安慰剂（5.3%【15/283】）相比，Veklury在第28天新冠肺炎相关住院或全因死亡的复合主要终点风险降低了87%（0.7%【2/279】），具有统计学意义p=0.008。在研究中，到第28天，两组均未观察到死亡。在本试验中，Veklury和安慰剂在各种门诊环境中的安全性特征相似，服用Veklury的患者中最常见的治疗后出现的不良事件（≥5%）是恶心和头痛。这些数据还与世界各地的其他监管机构共享，并提交给科学同行评审出版物。</blockquote></p><p> This expanded indication in the EU adds to the previous Conditional Marketing Authorization of Veklury enabling the treatment of COVID-19 in adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).</p><p><blockquote>欧盟的这一扩大适应症增加了Veklury之前的有条件上市许可，使其能够治疗需要补充氧气（治疗开始时的低流量或高流量氧气或其他无创通气）的肺炎成人和青少年（12岁至18岁以下，体重至少40 kg）的COVID-19。</blockquote></p><p> \"The swift action of the European Commission is a testament to the need for effective treatments that can be used earlier in the course of disease to help people with COVID-19 across Europe,\" said Merdad Parsey, M.D., Ph.D., Chief Medical Officer, Gilead Sciences. \"As we learn more about how COVID-19 disease progresses, it is clear that an antiviral like Veklury can have a significant impact if used early in the course of disease. As the antiviral standard of care for patients hospitalized with COVID-19, we are proud of the role Veklury continues to play on the front lines of the pandemic, and we believe Veklury will now be able to help more patients decrease their time to recovery from COVID-19 in Europe.\"</p><p><blockquote>吉利德科学首席医疗官、医学博士Merdad Parsey说：“欧盟委员会的迅速行动证明了需要有效的治疗方法，这些方法可以在疾病过程的早期使用，以帮助欧洲各地的COVID-19患者。”“随着我们对COVID-19疾病如何进展的了解越来越多，很明显，如果在病程早期使用，像Veklury这样的抗病毒药物可以产生重大影响。作为COVID-19住院患者的抗病毒护理标准，我们对Veklury在大流行前线继续发挥的作用感到自豪，我们相信Veklury现在将能够帮助欧洲更多患者缩短从COVID-19中康复的时间。”</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"GILD":"吉利德科学"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1149530831","content_text":"Gilead gained in premarket trading as European Commission approved a variation to the Conditional Marketing Authorization for Veklury.Gilead Sciences, Inc. today announced that the European Commission (EC) has approved a variation to the Conditional Marketing Authorization for Veklury® (remdesivir) to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19. This decision follows the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), to expand the indication for Veklury on December 16.\n\"As the rates of COVID-19 climb again and new variants like Omicron emerge, we need effective tools like Veklury to treat various stages of the disease,\" said Roger Paredes, MD, PhD, Chief Infectious Diseases Department, and IrsiCaixa AIDS Research Institute Hospital Universitari Germans Trias I Pujol Badalona, Spain. \"We can now use Veklury to help prevent high-risk patients from progressing to more severe disease, even when they do not require oxygen, as well as continue to utilize Veklury as a key tool in the treatment of severe disease. This latest approval will also help to relieve some of the pressure on healthcare systems that are already under significant strain from the burden of COVID-19.\"\nThe EC’s decision is supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. In the study, no deaths were observed in either arm by Day 28. The safety profile was similar between Veklury and placebo across the variety of outpatient settings in this trial, with the most common treatment emergent adverse events (≥5%) in patients taking Veklury being nausea and headache. These data have also been shared with other regulatory agencies around the world and submitted for scientific peer-reviewed publication.\nThis expanded indication in the EU adds to the previous Conditional Marketing Authorization of Veklury enabling the treatment of COVID-19 in adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).\n\"The swift action of the European Commission is a testament to the need for effective treatments that can be used earlier in the course of disease to help people with COVID-19 across Europe,\" said Merdad Parsey, M.D., Ph.D., Chief Medical Officer, Gilead Sciences. \"As we learn more about how COVID-19 disease progresses, it is clear that an antiviral like Veklury can have a significant impact if used early in the course of disease. As the antiviral standard of care for patients hospitalized with COVID-19, we are proud of the role Veklury continues to play on the front lines of the pandemic, and we believe Veklury will now be able to help more patients decrease their time to recovery from COVID-19 in Europe.\"","news_type":1,"symbols_score_info":{"GILD":0.9}},"isVote":1,"tweetType":1,"viewCount":1653,"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":3,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/693712913"}
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