Reuters: U.S. FDA says some data testing Novartis’ $2 million gene therapy was manipulated
U.S. regulators want to know why Novartis waited until after the Swiss drugmaker’s $2.1 million gene therapy was approved to disclose a problem with testing data. The Food and Drug Administration said earlier this week that the manipulated data that involved testing was done with animals, not patients. The agency said they remain confident that the drug, called Zolgensma, should stay on the market despite this revelation. They are investigating the matter and may consider criminal or civil penalties if appropriate. Approved in May for children under two, Zolgensma is the most expensive drug treatment ever. It’s a one-time...
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