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0 0 -0.00281954887218039 -0.00281954887218039 -0.00187969924812026 -0.012218045112782 -0.0112781954887217 0.00093984962406013
Stock impact report

FDA goes on offense amid surge of criticism for recent drug decisions [CNN]

uniQure N.V. - Ordinary Shares (QURE) 
Last uniqure n.v. - ordinary shares earnings: 4/29 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: uniqure.com/investors-newsroom/overview.php
Company Research Source: CNN
reporters Thursday to defend the agency's recent decision on an experimental medicine, calling it a “failed therapy” and railing against outside critics. The call focused on the FDA's decision to ask for an additional clinical trial from the biotechnology company UniQure before greenlighting it to apply for approval of its gene therapy for Huntington's disease, a fatal neurodegenerative disorder. Patients and the company had hoped the therapy could move into an FDA review based on existing evidence, a hope that was dashed Monday. But the regulator, who spoke on the condition of anonymity, also attacked outside scientists who serve on advisory committees for the agency, saying they “do not do their homework” and may be motivated by financial conflicts of interest. The official additionally singled out Dr. Janet Woodcock, a retired FDA veteran who called the UniQure decision “truly evil” in an interview with the New York Times this week. “Dr. Woodcock is an esteemed regulator,” th Show less Read more
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