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互聯網 2021-04-09 00:45:26

吹??梢?,不要上天了,欺負俺們都不懂英文?看看國外最新評價,2010年11月15日的[淘股吧]

Johnson & Johnsons Heart-failure Drug Safe But Has No Additional Efficacy 11/15/2010 3:06 AM ET Tweet

RELATED NEWSJohnson & Johnson Inducts Alex Gorsky, Sheri McCoy To Executive Committee Johnson & Johnson Reveals Executive Appointments - Quick Facts Johnson & Johnson Voluntarily Recalls Rolaids Chewable Products Johnson & Johnson Launching €24.75/shr Offer To Buy Crucell JNJ, Merck Recall 12 Mylanta Liquid Products Over Labelling - Update Trade JNJ now withTOP MARKET NEWSSwiss Franc Soars To 2-day High Against Most Majors US Dollar Drops To 2-day Low Against Majors Obama: Afghanistan StrategyOn TrackRIM Q3 Profit Rises 45%, Tops Estimate; Sees Q4 Earnings Above Consensus Accenture Q1 Profit Rises, Tops View; Lifts FY11 View - Update (RTTNews) - After years of controversy, Johnson & Johnsons (JNJ: News ) subsidiary Scios Inc. has finally provided answers to nagging questions about safety risks and less-than-convincing efficacy of its heart-failure drug Natrecor.

Natrecor was approved by the FDA in 2001 to treat a severe form of heart disease called acutely decompensated heart failure, or ADHF, who have dyspnea or shortness of breath at rest or with minimal activity.

ADHF is the leading cause of hospitalization in Americans aged over 65. The symptoms and signs of ADHF include extreme fatigue and shortness of breath, worsening kidney function, severe swelling, sudden weight gain and a distended jugular vein along the side of the neck. Intravenous vasodilators such as nitroglycerin, nitroprusside are commonly used in ADHF.

Natrecor that was intended to be used primarily in the hospital setting, became a brisk seller after its launch, generating sales of $14.1 million in 2001 and $107.3 million in 2002. The increasing sales of Natrecor led to Scios being acquired by Johnson & Johnson for $2.4 billion in early 2003. In the following year, sales of Natrecor peaked at $400 million, according to reports.

All was going well for Natrecor until studies linking the drug to kidney problems and higher death rates among patients were published in the April 2005 issue of the Journal of the American Medical Association.

As if Natrecor didnt have enough controversy swirling around it, the drug also became the subject of an inquiry by the Justice Department in 2005, following allegations about its off-label uses. And the reason - though Natrecor was intended to treat hospitalized patients under close medical supervision, it was alleged that Johnson & Johnsons aggressive marketing allowed the drug to be used in outpatient clinics as regular infusions at a much greater dose and for longer than the recommended time period.

Following reports of safety concerns and allegations of off-label uses , sales of Natrecor, which was once believed to have blockbuster potential, took a slump in 2005 and have never recovered since then. Johnson & Johnson doesnt provide the sales break-up for Natrecor.

In the wake of negative publicity, an FDA panel of cardiology and heart failure clinicians was convened in 2005, which recommended that Natrecor should be strictly limited to use in patients with only acutely decompensated congestive heart failure who have dyspnea at rest. The panel also suggested that Scios undertake clinical trials to further assess the risks and benefits of Natrecor. One of the studies to assess the long-term clinical outcomes and benefit/risk profile of Natrecor in patients with acutely decompensated heart failure dubbed ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure trial) was started in 2007.

------------------------------感謝google翻譯。

今天的焦點Johnson & Johnsons Heart-failure Drug Safe But Has No Additional Efficacy強生公司性心力衰竭藥物安全的,但沒有額外的功效 11/15/2010 3:06 AM ET 2010年11月15日上午03時06分東部 Tweet 鳴叫

RELATED NEWS相關新聞 Johnson & Johnson Inducts Alex Gorsky, Sheri McCoy To Executive Committee 強生公司導入亞歷Gorsky,執行委員會和Sheri麥科伊 Johnson & Johnson Reveals Executive Appointments - Quick Facts 強生公司揭示長官委任-快覽 Johnson & Johnson Voluntarily Recalls Rolaids Chewable Products 強生公司咀嚼片產品自愿召回羅來滋 Johnson & Johnson Launching €24.75/shr Offer To Buy Crucell 強生公司發射€24.75/shr求購Crucell JNJ, Merck Recall 12 Mylanta Liquid Products Over Labelling - Update 強生,默克公司召回超過12 Mylanta液體產品標簽-更新 Trade JNJ now with 現在貿易強生 TOP MARKET NEWS 最大的市場新聞 Swiss Franc Soars To 2-day High Against Most Majors 瑞士法郎飆升至2日對大多數專業高 US Dollar Drops To 2-day Low Against Majors 美元下降到2天的新低,專業 Obama: Afghanistan StrategyOn Track奧巴馬:阿富汗戰略“跟蹤” RIM Q3 Profit Rises 45%, Tops Estimate; Sees Q4 Earnings Above Consensus RIM公司第三季度盈利回升45%,上衣估計;預計第四季度企業盈利以上 Accenture Q1 Profit Rises, Tops View; Lifts FY11 View - Update 埃森哲公司第一季度利潤回升,上衣查看;升降機2011查看-更新 (RTTNews) - After years of controversy, Johnson & Johnsons (JNJ: News ) subsidiary Scios Inc. has finally provided answers to nagging questions about safety risks and less-than-convincing efficacy of its heart-failure drug Natrecor. (綜合訊) -經過多年的爭論,強生公司(強生: 新聞 )的子公司Scios公司終于提供Natrecor解答有關安全問題困擾的風險和低于其療效的藥物有說服力的心臟衰竭。

Natrecor was approved by the FDA in 2001 to treat a severe form of heart disease called acutely decompensated heart failure, or ADHF, who have dyspnea or shortness of breath at rest or with minimal activity. Natrecor在2001年被批準用于治療嚴重的心臟病稱為急性失代償性心力衰竭,或ADHF,誰在休息或以最小的活動性呼吸困難或呼吸短促由FDA。

ADHF is the leading cause of hospitalization in Americans aged over 65. ADHF是住院的65歲以上的美國人中的首要原因。 The symptoms and signs of ADHF include extreme fatigue and shortness of breath, worsening kidney function, severe swelling, sudden weight gain and a distended jugular vein along the side of the neck.癥狀和體征包括ADHF極度疲勞,呼吸急促,腎功能惡化,嚴重腫脹,體重突然增益和擴張沿頸部一側頸內靜脈。 Intravenous vasodilators such as nitroglycerin, nitroprusside are commonly used in ADHF.靜脈血管擴張劑,如硝酸甘油,硝普鈉是常用的ADHF。

Natrecor that was intended to be used primarily in the hospital setting, became a brisk seller after its launch, generating sales of $14.1 million in 2001 and $107.3 million in 2002. Natrecor原打算用在醫院環境為主,推出后成為活躍賣家,2002年發電1410萬美元的銷售額在2001年和一億零七百三十零萬美元。 The increasing sales of Natrecor led to Scios being acquired by Johnson & Johnson for $2.4 billion in early 2003.對Natrecor的銷售增加導致Scios被收購24億美元在2003年初由強生公司。 In the following year, sales of Natrecor peaked at $400 million, according to reports.在接下來的一年里,Natrecor銷售高峰4億美元,據報道。

All was going well for Natrecor until studies linking the drug to kidney problems and higher death rates among patients were published in the April 2005 issue of the Journal of the American Medical Association.一切都很順利,直到前往Natrecor連接藥物的研究問題和腎臟的患者死亡率較高,在2005年4月的美國醫學協會雜志上發表。

As if Natrecor didnt have enough controversy swirling around it, the drug also became the subject of an inquiry by the Justice Department in 2005, following allegations about its off-label uses.仿佛Natrecor沒有足夠的爭議圍繞它旋轉,這種藥物也成為了一個由司法部調查對象在2005年之后,有關其標示外用途的指控。 And the reason - though Natrecor was intended to treat hospitalized patients under close medical supervision, it was alleged that Johnson & Johnsons aggressive marketing allowed the drug to be used in outpatient clinics as regular infusions at a much greater dose and for longer than the recommended time period.其原因 - 盡管Natrecor是為了處理由醫護人員指導下住院的患者,據稱,強生公司的積極的營銷使藥物被用來作為常規輸注在門診診所在更大的劑量,比建議的時間較長時期。

Following reports of safety concerns and allegations of off-label uses , sales of Natrecor, which was once believed to have blockbuster potential, took a slump in 2005 and have never recovered since then.以下的安全關切和標簽外用途的指控報告,Natrecor,這是一度被認為有潛在的重磅炸彈,銷售于2005年蕭條以來,從未再收回。 Johnson & Johnson doesnt provide the sales break-up for Natrecor.強生公司不提供銷售突破,注冊Natrecor。

In the wake of negative publicity, an FDA panel of cardiology and heart failure clinicians was convened in 2005, which recommended that Natrecor should be strictly limited to use in patients with only acutely decompensated congestive heart failure who have dyspnea at rest.在負面的宣傳,對心血管病和心力衰竭的臨床FDA專家小組召開了2005年之后,其中建議Natrecor應嚴格限制使用,只有在急性失代償性充血性心力衰竭病人誰在休息呼吸困難。 The panel also suggested that Scios undertake clinical trials to further assess the risks and benefits of Natrecor.該小組還建議,Scios進行臨床試驗,以進一步評估風險和Natrecor好處。 One of the studies to assess the long-term clinical outcomes and benefit/risk profile of Natrecor in patients with acutely decompensated heart failure dubbed ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure trial) was started in 2007.其中一項研究,評估與急性失代償性稱為升序高頻(臨床Nesiritide急性失代償性心力衰竭有效性試驗研究)失敗的長期臨床療效和患者的利益/風險Natrecor于2007年開始。

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