Novartis exec sold shares before drug data manipulation made public

诺华重磅药物涉嫌数据操纵续:有公司高管提前抛售巨额股票

2019-08-19 18:03:00 YAHOO!FINANCE

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An unnamed Novartis executive sold 925,400 Swiss francs worth of shares less than three weeks before the U.S. Food and Drug Administration announced data from tests of its gene therapy Zolgensma had been manipulated. Novartis announced the stock sale by an executive member of the board of directors or a member of the executive committee in a Swiss stock exchange filing dated July 19. The sale was first reported by Swiss newspaper SonntagsZeitung on Sunday. A Novartis spokesman told Reuters, "As is usual in such cases, the transaction was thoroughly checked beforehand and then approved accordingly. The person in question was not in possession of relevant material information." The sale was made after the company had informed the FDA about the data manipulation but before the FDA announced it publically on Aug 6. Shares in Novartis fell almost 3 percent the day after the FDA announcement. The FDA said this month that Novartis notified regulators in June - more than a month after Zolgensma had been approved - that some of the early testing data had been manipulated. The company had been aware of the problems for as long as two months before the drug's U.S. approval, the FDA said, and Novartis could face criminal or civil penalties. Novartis said this month that it learned of allegations of data manipulation in mid-March and finished a preliminary investigation into the allegations in early May, confirming data discrepancies and raising data integrity concerns. The data was used to illustrate comparability between an early version of Zolgensma and the later version of the treatment, which was manufactured using a different process. The FDA said it does not believe that the manipulation impacts the safety or testing surrounding the version of the drug, which treats spinal muscular atrophy (SMA), the leading genetic cause of death in infants.
一位未透露姓名的诺华(Novartis)高管在美国食品药品监督管理局(Food and Drug Administration)( FDA )宣布基因治疗实验数据被操纵之前不到三周就出售了价值925400瑞士法郎的股票。 诺华公司( Novartis )在7月19日提交的一份瑞士证券交易所( Swiss Stock Exchange )文件中宣布,董事会一名执行成员或执行委员会一名成员出售了该公司的股票。这次拍卖是瑞士报纸 SonntagsZeitung 周日首次报道的。 诺华(Novartis)公司的一位发言人对路透社说,“在这种情况下,通常情况下,交易事先经过彻底检查,然后得到相应的批准。有关人士并无拥有有关的资料。 这次出售是在该公司告知 FDA 数据操作后进行的,但在 FDA 于8月6日公开宣布之前。 在 FDA 宣布之后,诺华(Novartis)的股价当天下跌了近3%。 FDA 本月表示,诺华(Novartis)在6月份(佐尔甘斯曼获得批准一个多月后)通知监管机构,一些早期检测数据被篡改。 FDA 表示,早在药品获得美国批准前两个月,诺华就已经意识到了这些问题,诺华(Novartis)可能面临刑事或民事处罚。 诺华(Novartis)本月表示,该公司在3月中旬获悉了有关数据操纵的指控,并在5月初完成了对这些指控的初步调查,证实了数据差异,并引发了数据完整性方面的担忧。 这些数据被用来说明早期的 Zolgensma 和后期的治疗之间的可比性,后者是用不同的方法制造的。 美国食品和药物管理局表示,它不认为这些操作会影响药物的安全性,也不会影响药物的测试。这种药物治疗脊髓肌肉萎缩症( SMA )是婴儿死亡的主要基因原因。

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