BIO 2019 Notebook: Sharpless On Pricing, Marks On Gene Therapy, Takeda On M&A
News and views from day two of the BIO International Convention: US FDA's Sharpless decries the focus on the price of "medical miracle" Zolgensma; CBER Director Marks talks about how his division will staff up to review cell and gene therapy candidates; and Takeda explains why its business development philosophy leads to the valuation seen in the Ariad buyout.
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Data Manipulation Not Common, But Happens "More Than I Would Have Expected," US FDA's Sharpless Says
As fallout from the Novartis Zolgensma data manipulation incident continues, US FDA acting commissioner Norman Sharpless notes that "at some level we have to trust the sponsors."