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Since the Food and Drug Administration blasted Novartis (NVS) earlier this month over data manipulation, one of the major questions looming over the matter has been why the agency came down so publicly on the drug maker. The answer, according to a top FDA official, is because the stakes were too high to do otherwise. Dr. Peter Marks, who wrote the memo that created a storm of controversy around Novartis and data used to support approval of the drug Zolgensma, said in an interview that any case in which data are mishandled and patients are harmed could set the whole field of gene therapy back, just as the death of a patient, Jesse Gelsinger, froze research two decades ago. (Herper, 8/21)

The Novartis (NVS) scientist who was ousted by the drug maker in connection with a scandal over data manipulation broke his silence late Monday, saying through a lawyer that he categorically denied any wrongdoing and was “prepared to assert his rights and defend his conduct accordingly.” The researcher, Brian Kaspar, was dismissed from the company, along with his brother, Allan. Both were leading scientists at AveXis, which developed the gene therapy Zolgensma and which was later acquired by Novartis. The Food and Drug Administration earlier this month accused the drug maker of falsifying preclinical data related to its application for approval of the treatment. (Herper, 8/19)