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2021-11-17

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Pfizer asks US officials to OK promising COVID-19 pill<blockquote>辉瑞要求美国官员批准有前途的COVID-19药物</blockquote>

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The Food and Drug Administration is already reviewing a competing pill from Merck and several smaller drugmakers are also expected to seek authorization for their own antiviral pills in the coming months.<blockquote>辉瑞公司的药物已被证明可以显着降低冠状病毒感染者的住院率和死亡率。美国食品和药物管理局已经在审查默克公司的一种竞争药物，预计几家较小的制药商也将在未来几个月内寻求自己的抗病毒药物的授权。</blockquote> “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application,\" said Pfizer CEO Albert Bourla, in a statement.<blockquote>辉瑞首席执行官Albert Bourla在一份声明中表示：“我们正在尽快采取行动，努力将这种潜在的治疗方法送到患者手中，我们期待与美国FDA合作审查我们的申请。”</blockquote> Specifically, Pfizer wants the drug available for adults who have mild-to-moderate COVID-19 infections and are at risk of becoming seriously ill. That's similar to how other drugs are currently used to treat the disease. But all FDA-authorized COVID-19 treatments require an IV or injection given by a health professional at a hospital or clinic.<blockquote>具体来说，辉瑞希望该药物可用于患有轻度至中度COVID-19感染并有患重病风险的成年人。这与目前其他药物用于治疗该疾病的方式类似。但所有FDA授权的COVID-19治疗都需要由医院或诊所的健康专家进行静脉注射或注射。</blockquote> The FDA is holding a public meeting on the Merck pill later this month to get the opinion of outside experts before making its decision. The agency isn’t required to convene such meetings and it’s not yet known whether Pfizer’s drug will undergo a similar public review.<blockquote>FDA将于本月晚些时候就默克药丸举行公开会议，在做出决定之前征求外部专家的意见。该机构不需要召开此类会议，目前尚不清楚辉瑞的药物是否会接受类似的公开审查。</blockquote> Some experts predict COVID-19 treatments eventually will be combined to better protect against the worst effects of the virus.<blockquote>一些专家预测，新冠肺炎治疗方法最终将被结合起来，以更好地抵御病毒的最严重影响。</blockquote> Pfizer reported earlier this monththat its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19. The company studied its pill in people who were unvaccinated and faced the worst risks from the virus due to age or health problems, such as obesity. If authorized, the FDA will have to weigh making the pill available for vaccinated people dealing with breakthrough infections, since they weren't part of the initial tests.<blockquote>辉瑞公司本月早些时候报告称，其药物将有COVID-19早期症状的高危成年人的住院率和死亡率降低了89%。该公司在未接种疫苗且因年龄或肥胖等健康问题而面临最严重病毒风险的人群中研究了其药丸。如果获得授权，FDA将不得不权衡是否将该药丸提供给应对突破性感染的接种疫苗的人，因为他们不是最初测试的一部分。</blockquote> For best results, patients need to start taking the pills within three days of symptoms, underscoring the need for speedy testing and diagnosis. That could be a challenge if another COVID-19 surge leads to testing delays and shortages seen last winter.<blockquote>为了获得最佳效果，患者需要在出现症状的三天内开始服药，这强调了快速检测和诊断的必要性。如果另一次新冠肺炎激增导致去年冬天出现的测试延迟和短缺，这可能是一个挑战。</blockquote> Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body. That's different than the Merck pill, which causes tiny mutations in the coronavirus until the point that it can't reproduce itself.<blockquote>辉瑞的药物是已有数十年历史的蛋白酶抑制剂抗病毒药物家族的一部分，蛋白酶抑制剂彻底改变了艾滋病毒和丙型肝炎的治疗。这些药物阻断了病毒在人体内繁殖所需的一种关键酶。这与默克药丸不同，默克药丸会导致冠状病毒发生微小突变，直至无法自我繁殖。</blockquote> On Tuesday,Pfizer signed a deal a with U.N.-backed groupto allow generic drugmakers to produce low-cost versions of the pill for certain countries. Merck has a similar deal for its pill, which was authorized in Britain earlier this month.<blockquote>周二，辉瑞与联合国支持的组织签署了一项协议，允许仿制药制造商为某些国家生产低成本版本的避孕药。默克公司的药物也有类似的协议，该药物本月早些时候在英国获得授权。</blockquote> The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they usually have to be given via time-consuming infusions by health professionals, and limited supplies were strained by the last surge of the delta variant.<blockquote>美国已经批准了另一种针对COVID-19的抗病毒药物瑞德西韦，并授权了三种帮助免疫系统对抗病毒的抗体疗法。但它们通常必须由卫生专业人员通过耗时的输液来给药，而有限的供应因德尔塔变异毒株的最后一次激增而紧张。</blockquote> The U.S. government has already committed to purchasing Merck's pill. Federal authorities were in negotiations with Pfizer to buy millions of doses of its pill, according to an official familiar with the matter.<blockquote>美国政府已经承诺购买默克公司的药丸。据一位知情官员透露，联邦当局正在与辉瑞公司就购买数百万剂该药物进行谈判。</blockquote>","source":"lsy1603278176698","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>Pfizer asks US officials to OK promising COVID-19 pill<blockquote>辉瑞要求美国官员批准有前途的COVID-19药物</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\">\nPfizer asks US officials to OK promising COVID-19 pill<blockquote>辉瑞要求美国官员批准有前途的COVID-19药物</blockquote>\n</h2>\n<h4 class=\"meta\">\n\nAssociated Press2021-11-17 19:07\n\n</h4>\n</header>\n<article>\nPfizer asked U.S. regulators Tuesday to authorize its experimental pill for COVID-19, setting the stage for a likely launch this winter of a promising treatment that can be taken at home.<blockquote>辉瑞周二要求美国监管机构批准其针对COVID-19的实验性药物，为今年冬天可能推出一种可以在家中服用的有前途的治疗方法奠定了基础。</blockquote> The company's filing comes as new infections are rising once again in the United States, driven mainly by hot spots in states where colder weather is driving more Americans indoors.<blockquote>该公司提交文件之际，美国新增感染病例再次上升，这主要是由各州的热点地区推动的，这些州的寒冷天气迫使更多美国人呆在室内。</blockquote> Pfizer’s pill has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The Food and Drug Administration is already reviewing a competing pill from Merck and several smaller drugmakers are also expected to seek authorization for their own antiviral pills in the coming months.<blockquote>辉瑞公司的药物已被证明可以显着降低冠状病毒感染者的住院率和死亡率。美国食品和药物管理局已经在审查默克公司的一种竞争药物，预计几家较小的制药商也将在未来几个月内寻求自己的抗病毒药物的授权。</blockquote> “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application,\" said Pfizer CEO Albert Bourla, in a statement.<blockquote>辉瑞首席执行官Albert Bourla在一份声明中表示：“我们正在尽快采取行动，努力将这种潜在的治疗方法送到患者手中，我们期待与美国FDA合作审查我们的申请。”</blockquote> Specifically, Pfizer wants the drug available for adults who have mild-to-moderate COVID-19 infections and are at risk of becoming seriously ill. That's similar to how other drugs are currently used to treat the disease. But all FDA-authorized COVID-19 treatments require an IV or injection given by a health professional at a hospital or clinic.<blockquote>具体来说，辉瑞希望该药物可用于患有轻度至中度COVID-19感染并有患重病风险的成年人。这与目前其他药物用于治疗该疾病的方式类似。但所有FDA授权的COVID-19治疗都需要由医院或诊所的健康专家进行静脉注射或注射。</blockquote> The FDA is holding a public meeting on the Merck pill later this month to get the opinion of outside experts before making its decision. The agency isn’t required to convene such meetings and it’s not yet known whether Pfizer’s drug will undergo a similar public review.<blockquote>FDA将于本月晚些时候就默克药丸举行公开会议，在做出决定之前征求外部专家的意见。该机构不需要召开此类会议，目前尚不清楚辉瑞的药物是否会接受类似的公开审查。</blockquote> Some experts predict COVID-19 treatments eventually will be combined to better protect against the worst effects of the virus.<blockquote>一些专家预测，新冠肺炎治疗方法最终将被结合起来，以更好地抵御病毒的最严重影响。</blockquote> Pfizer reported earlier this monththat its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19. The company studied its pill in people who were unvaccinated and faced the worst risks from the virus due to age or health problems, such as obesity. If authorized, the FDA will have to weigh making the pill available for vaccinated people dealing with breakthrough infections, since they weren't part of the initial tests.<blockquote>辉瑞公司本月早些时候报告称，其药物将有COVID-19早期症状的高危成年人的住院率和死亡率降低了89%。该公司在未接种疫苗且因年龄或肥胖等健康问题而面临最严重病毒风险的人群中研究了其药丸。如果获得授权，FDA将不得不权衡是否将该药丸提供给应对突破性感染的接种疫苗的人，因为他们不是最初测试的一部分。</blockquote> For best results, patients need to start taking the pills within three days of symptoms, underscoring the need for speedy testing and diagnosis. That could be a challenge if another COVID-19 surge leads to testing delays and shortages seen last winter.<blockquote>为了获得最佳效果，患者需要在出现症状的三天内开始服药，这强调了快速检测和诊断的必要性。如果另一次新冠肺炎激增导致去年冬天出现的测试延迟和短缺，这可能是一个挑战。</blockquote> Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body. That's different than the Merck pill, which causes tiny mutations in the coronavirus until the point that it can't reproduce itself.<blockquote>辉瑞的药物是已有数十年历史的蛋白酶抑制剂抗病毒药物家族的一部分，蛋白酶抑制剂彻底改变了艾滋病毒和丙型肝炎的治疗。这些药物阻断了病毒在人体内繁殖所需的一种关键酶。这与默克药丸不同，默克药丸会导致冠状病毒发生微小突变，直至无法自我繁殖。</blockquote> On Tuesday,Pfizer signed a deal a with U.N.-backed groupto allow generic drugmakers to produce low-cost versions of the pill for certain countries. Merck has a similar deal for its pill, which was authorized in Britain earlier this month.<blockquote>周二，辉瑞与联合国支持的组织签署了一项协议，允许仿制药制造商为某些国家生产低成本版本的避孕药。默克公司的药物也有类似的协议，该药物本月早些时候在英国获得授权。</blockquote> The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they usually have to be given via time-consuming infusions by health professionals, and limited supplies were strained by the last surge of the delta variant.<blockquote>美国已经批准了另一种针对COVID-19的抗病毒药物瑞德西韦，并授权了三种帮助免疫系统对抗病毒的抗体疗法。但它们通常必须由卫生专业人员通过耗时的输液来给药，而有限的供应因德尔塔变异毒株的最后一次激增而紧张。</blockquote> The U.S. government has already committed to purchasing Merck's pill. Federal authorities were in negotiations with Pfizer to buy millions of doses of its pill, according to an official familiar with the matter.<blockquote>美国政府已经承诺购买默克公司的药丸。据一位知情官员透露，联邦当局正在与辉瑞公司就购买数百万剂该药物进行谈判。</blockquote>\n<div class=\"bt-text\">\n\n\n 来源：<a href=\"https://finance.yahoo.com/news/pfizer-asks-us-officials-ok-190336933.html\">Associated Press</a>\n为提升您的阅读体验，我们对本页面进行了排版优化\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"PFE":"辉瑞"},"source_url":"https://finance.yahoo.com/news/pfizer-asks-us-officials-ok-190336933.html","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1160710301","content_text":"Pfizer asked U.S. regulators Tuesday to authorize its experimental pill for COVID-19, setting the stage for a likely launch this winter of a promising treatment that can be taken at home.\nThe company's filing comes as new infections are rising once again in the United States, driven mainly by hot spots in states where colder weather is driving more Americans indoors.\nPfizer’s pill has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The Food and Drug Administration is already reviewing a competing pill from Merck and several smaller drugmakers are also expected to seek authorization for their own antiviral pills in the coming months.\n“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application,\" said Pfizer CEO Albert Bourla, in a statement.\nSpecifically, Pfizer wants the drug available for adults who have mild-to-moderate COVID-19 infections and are at risk of becoming seriously ill. That's similar to how other drugs are currently used to treat the disease. But all FDA-authorized COVID-19 treatments require an IV or injection given by a health professional at a hospital or clinic.\nThe FDA is holding a public meeting on the Merck pill later this month to get the opinion of outside experts before making its decision. The agency isn’t required to convene such meetings and it’s not yet known whether Pfizer’s drug will undergo a similar public review.\nSome experts predict COVID-19 treatments eventually will be combined to better protect against the worst effects of the virus.\nPfizer reported earlier this monththat its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19. The company studied its pill in people who were unvaccinated and faced the worst risks from the virus due to age or health problems, such as obesity. If authorized, the FDA will have to weigh making the pill available for vaccinated people dealing with breakthrough infections, since they weren't part of the initial tests.\nFor best results, patients need to start taking the pills within three days of symptoms, underscoring the need for speedy testing and diagnosis. That could be a challenge if another COVID-19 surge leads to testing delays and shortages seen last winter.\nPfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body. That's different than the Merck pill, which causes tiny mutations in the coronavirus until the point that it can't reproduce itself.\nOn Tuesday,Pfizer signed a deal a with U.N.-backed groupto allow generic drugmakers to produce low-cost versions of the pill for certain countries. Merck has a similar deal for its pill, which was authorized in Britain earlier this month.\nThe U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they usually have to be given via time-consuming infusions by health professionals, and limited supplies were strained by the last surge of the delta variant.\nThe U.S. government has already committed to purchasing Merck's pill. Federal authorities were in negotiations with Pfizer to buy millions of doses of its pill, according to an official familiar with the matter.","news_type":1,"symbols_score_info":{"PFE":0.9}},"isVote":1,"tweetType":1,"viewCount":1041,"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/878338208"}