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"The FDA has published a briefing document ahead of the May 24 meeting of its Endocrinologic and Metabolic Drugs Advisory Committee to discuss the new drug application (NDA) for IDegLira (Novo Nordisk), a fixed-dose combination of insulin degludec (Tresiba) and liraglutide (Victoza).", www.managedcaremag.com
"The briefing documents posted on FDA’s website include results from the two Phase III trials with the lixisenatide/Lantus® combination, not previously published US regulatory decisions on lixisenatide and the lixisenatide/Lantus® combination", www.pharmiweb.com
"U.S. Food and Drug Administration staff raised concerns about the usefulness of Sanofi’s diabetes treatment that combines two medications and questioned the results of clinical trials designed to show the therapy is superior to insulin alone.", www.bloomberg.com
"Amid slumping diabetes sales and impending biosimilar competition for its star drug Lantus, Sanofi is shaking up its top management team for the second time since CEO Olivier Brandicourt took the helm last year. Top diabetes and cardiovascular exec Pascale Witz is making an exit, and the beefed-up consumer unit will get a dedicated chief.", www.fiercepharma.com
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