Last week, the Food and Drug Administration (FDA) alleged that, “following the FDA’s approval of the product, the agency was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue that impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application (BLA) and reviewed by the FDA.”
While the agency didn’t say Zolgensma should be taken off the market because of the issues – a fact that Novartis has emphasized in its response to the allegations – it did bring up the specter of potential civil or criminal action against the firm over the alleged data manipulation. Hello and happy hump day, readers. In a statement, Novartis said that Brian Kaspar and Allan Kaspar – the previous chief scientific officer and R&D VP at AveXis, respectively – “have not been involved in any operations at AveXis since early May 2019 and are no longer with the company.” It’s unclear exactly why the pair were let go, but the timing of the departures syncs with the approval of Zolgensma in May. Read on for the day’s news. The fallout from allegations of data manipulation continues at drug giant Novartis, with the company reportedly axing brother scientists who held high-level posts at its subsidiary AveXis, which is at the heart of the controversy. Zolgensma is a gene therapy for the deadly rare disease spinal muscular atrophy (SMA) and comes with a $2.1 million list price, making it the most expensive drug in the world (at least on paper). The timeline of how this entire episode went down, however, remains murky – and Congressional lawmakers of both parties have already expressed their displeasure. Sy Mukherjee, @the_sy_guy, firstname.lastname@example.org Novartis CEO Vas Narasimhan said in a conference call last week that the company began investigating the issues immediately after hearing about them, and that the relevant employees would be “exiting” the firm.