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【drug-news】GSK有得有失, 乳癌药欧洲批准, 美国
Glaxo scores win in Europe after loss in U.S.
Friday December 14, 10:42 am ET
GlaxoSmithKline won a victory in Europe on a breast cancer drug Friday, a day after U.S. drug regulators hurt the company's bid to sell a cholesterol treatment over the counter.
On Friday, the European Medicines Agency gave Tyverb, a GSK breast cancer drug, a favorable opinion. The decision by the scientific body means the drug, used to treat severe cases of the disease, has a good chance of final approval when it's taken up by a European Union regulatory panel.
Tyverb already has been approved for specific uses by the U.S. Food and Drug Administration.
The bad news for Glaxo came Thursday, when an FDA advisory panel recommended against Merck's bid to sell its cholesterol drug Mevacor without a prescription. The panel said it was worried that patients wouldn't understand how to properly use the drug.
The decision was a blow to Glaxo (NYSE: GSK - News), which in November had licensed the rights to sell Mevacor over the counter. It was the third time regulators have turned down Merck's request to have Mevacor sold without a prescription but the first since GSK licensed the selling rights.
Headquartered in London, GlaxoSmithKline employs 6,000 in the Triangle. Shares were down 1.5 percent to $53.09 in morning trading Friday. 粗译稿
bizjournals.com
Glaxo【医】葛兰素scores win in Europe after loss in U.S.
葛兰素在美国遭拒后，获欧洲批准
Friday December 14, 10:42 am ET
GlaxoSmithKline葛兰素史克 公司总部所在地：英国 主要业务：制药 won a victory in Europe on a breast cancer drug Friday, a day after U.S. drug regulators[英]【史】选举调查[监视]委员 hurt the company's bid to sell a cholesterol【生化】胆固醇, 胆甾醇, 异辛甾烯醇treatment over the counter非处方药.
葛兰素史克的一种乳癌治疗药物周五在欧洲获批准，一日前美国药品监管署拒绝了这家公司将胆甾醇作为治疗乳癌的非处方药的上市投标。
On Friday, the European Medicines Agency gave Tyverb, a GSK breast cancer drug, a favorable opinion. The decision by the scientific body means the drug, used to treat severe cases of the disease, has a good chance of final approval when it's taken up by a European Union regulatory panel.
周五，欧洲药品监管署对Tyverb（葛兰素史克公司生产的一种乳癌治疗药物）作出了满意评价。这项由科学团体作出的决定意味着这种可用于乳癌患者的严格治疗的药物，很有希望获得欧盟医生规章的最后批准。
Tyverb already has been approved for specific uses by the U.S. Food and Drug Administration.
Tyverb已经被美国FDA批准用于特殊的治疗。
The bad news for Glaxo came Thursday, when an FDA advisory panel recommended against Merck's bid to sell its cholesterol drug Mevacor【医】是一种降血脂药(含lovastatin)without a prescription. The panel said it was worried that patients wouldn't understand how to properly use the drug.
葛兰素史克的坏消息来自于周四，FDA的一名医生顾问建议否决默克公司的关于将它生产的胆甾醇药物Mevacor（【医】是一种降血脂药(含lovastatin)）作为非处方药销售的提案。这名医生称担心患者不能够很好的理解如何恰当的服用药物。
The decision was a blow to Glaxo (NYSE: GSK - News), which in November had licensed the rights to sell Mevacor over the counter. It was the third time regulators have turned down Merck's request to have Mevacor sold without a prescription but the first since GSK licensed the selling rights.
这项决定是对葛兰素公司的一项打击，因为在11月份就已经取得Mevacor作为非处方药销售的许可。这是监管署第三次拒绝默克公司将Mevacor作为非处方药销售的申请，但是葛兰素史克公司取得销售许可后的第一次拒绝。
Headquartered in London, GlaxoSmithKline employs 6,000 in the Triangle. Shares were down 1.5 percent to $53.09 in morning trading Friday.
公司总部设在伦敦的葛兰素史克公司雇用了6000名雇员。在周五的交易市场上，葛兰素史克的股份下降了1.5个百分点，为53.09美元。 编译。467个字符。
葛兰素史克的一种乳癌治疗药物周五在欧洲获批准，一日前美国药品监管署拒绝了这家公司将胆甾醇作为治疗乳癌的非处方药的上市投标。
周五，欧洲药品监管署对Tyverb（葛兰素史克公司生产的一种乳癌治疗药物）作出了满意评价。这项由科学团体作出的决定意味着这种可用于乳癌患者的严格治疗的药物，很有希望获得欧盟医生规章的最后批准。
Tyverb已经被美国FDA批准用于特殊的治疗。
葛兰素史克的坏消息来自于周四，FDA的一名医生顾问建议否决默克公司的关于将它生产的胆甾醇药物Mevacor（【医】是一种降血脂药(含lovastatin)）作为非处方药销售的提案。这名医生称担心患者不能够很好的理解如何恰当的服用药物。
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作者:admin@医学,生命科学 2011-02-13 05:11
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