Senator Grassley seeks info on Novartis's Zolgensma data issues

Grassley 参议员希望了解诺华(Novartis)公司的 Zolgensma 数据问题

2019-08-13 05:27:05 Reuters

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Aug 12 - U.S. Senate Finance Committee Chairman Chuck Grassley has sought more information from Swiss drugmaker Novartis AG on the reasons for "intentional withholding" of data related to its $2 million gene therapy, Zolgensma, by Aug. 23. In a letter dated Aug.9 to the drugmaker's Chief Executive Officer Vasant Narasimhan, Republican Grassley asked the company to provide all records on its internal inquiry into Zolgensma data manipulation https://www.grassley.senate.gov/sites/default/files/constituents/2019-08-09%20CEG%20to%20Novartis%20(Misconduct).pdf. The drugmaker had last week said it knew about the discrepancies in data it submitted to regulators while it sought approval of its gene therapy, but delayed notifying authorities until it has completed an internal investigation.
8月12日-美国参议院财政委员会主席 Chuck Grassley 向瑞士制药公司诺华(Novartis) AG 寻求更多信息,说明其在8月23日之前故意隐瞒200万美元基因治疗相关数据的原因。 在8月9日给制药商首席执行官 Vasant Narasimhan 的一封信中,共和党人 Grassley 要求该公司提供其对 Zolgensma 数据操纵 https 的内部调查的所有记录: http://www.grassley.senate.gov/sites/default/files/components/2019-08-09%20CEG %20%20 Novartis %20( Misact )。pdf 。 这家制药商上周曾表示,在寻求获得基因治疗批准的同时,它知道向监管机构提交的数据存在差异,但在完成一项内部调查之前,它推迟了通知当局。

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