Top Novartis scientists exited company ahead of data scandal

数据丑闻爆发前,诺华( Novartis )的顶级科学家纷纷离职

2019-08-15 04:36:13 pharmamanufacturing


More details are emerging about the months leading up to Novartis’s admission that data results for its gene therapy Zolgensma were manipulated. News of the data issues broke last week when the FDA announced that it plans to take action against Novartis, which admitted that data from an animal study was tampered with before the drug was approved. The FDA said that the findings would not impact its safety assessment of the drug, but if it would have known about the data falsification, it would have delayed approval of Zolgensma. Novartis had previously stated that was in the process of letting go executives involved in the data manipulation. But in a recent statement, Novartis said that two of the top scientists at AveXis, its gene therapy unit, have not been involved in its operations since May. This latest revelation provides further evidence that Novartis knew about the data problems a full month before it informed the FDA on June 28. Novartis has also said that it is standard procedure to fully investigate internal issues before informing the FDA. The company has since combined the two jobs of the ousted scientists and hired a new person to fill the role.  The FDA has threatened Novartis with “civil or criminal penalties.” /* Create two equal columns that floats next to each other */ .column1 { float: left; width: 35%; padding: 10px; } .column2 { float: right; width: 65%; padding: 10px 20px; } /* Clear floats after the columns */ .row:after { content: ""; display: table; clear: both; } /* Responsive layout - makes the two columns stack on top of each other instead of next to each other */ @media screen and (max-width: 600px) { .column1 { width: 100%; } .column2 { width: 100%; } } label { color: #000000; font-size: 14px; } input[type=text] { width: 100%; padding: 5px 20px; margin: 10px 0; box-sizing: border-box; border: 1px solid #cccccc; color: #868383; } input[type=email] { width: 100%; padding: 5px 20px; margin: 10px 0; box-sizing: border-box; border: 1px solid #cccccc; color: #868383; } select{ width: 100%; padding: 3px 20px; margin: 10px 0; border: 1px solid #cccccc; color: #868383; } input[type=submit] { padding: 10px 20px; margin: 10px 0; box-sizing: border-box; border: 1px solid #cccccc; font-size: 18px; background-color: #f40c00; color: #ffffff; font-weight: bold; display: block; margin: auto; width: 50%; }
在诺华( Novartis )承认其基因疗法 Zolgensma 的数据结果受到操纵之前的几个月,更多细节正在浮出水面。 上周,当 FDA 宣布计划对诺华采取行动时,有关数据问题的消息就被打破了。诺华(Novartis)承认,一项动物研究的数据在药品获得批准之前就被篡改了。FDA 表示,这一发现不会影响其对该药的安全性评估,但如果它知道数据造假,就会延迟批准佐尔格森玛。 诺华(Novartis)此前曾表示,该公司正在让高管参与数据操纵。但在最近的一份声明中,诺华表示,自5月份以来,其基因治疗部门 AveXis 的两位顶级科学家并未参与其业务。这一最新的发现进一步证明,诺华(Novartis)在6月28日通知 FDA 之前整整一个月就了解了数据问题。诺华(Novartis)还表示,在通知 FDA 之前,全面调查内部问题是标准程序。 此后,该公司合并了被赶下台的科学家的两个职位,并聘请了一个新的人来担任这个角色。 FDA 已经威胁诺华(Novartis)公司将受到“民事或刑事处罚”。 /*创建两个相互浮动的相等列*/。collen1{ float : left ;宽度:35%;填充:10px ;}coln2{} float : right ;宽度:65%;填充:10px20px ;}/*列后的 clear */。行:在{ content :"" display : table ; clear : two ;}/* Responsive 布局之后,将两列堆栈放在一起,而不是隔壁*/@ media 屏幕和(最大宽度:600px ){。专栏1{宽度:100%;}专栏2{宽度:100%;}标签{颜色:#000000;字体大小:14px ;}输入[类型=文本]{宽度:100%;填充:5px 20px ;边距:10px 0;框大小:边框;边框:1px 固体# cccccc ;颜色:#868383;}输入[类型=电子邮件]{宽度:100%;填充:5px 20px ;边框: px 大小:1个框;边框:1 px 固体# cccc ;颜色:#8683;}