A Busy Year-End, In Brief: December Brings Slate Of Approvals, And Setbacks

 
• By Sue Sutter, Sarah Karlin-Smith, and Emily Hayes

In addition to a spate of FDA approvals closing out the year, Roche contended with trial failures and Actavis received a “complete response” letter for its nebivolol/valsartan combination.

FDA gave Novo Nordisk AS an early Christmas gift with the Dec. 23 approval of Saxenda (liraglutide) for chronic weight management, with no requirement for a new cardiovascular outcomes trial of the GLP-1 receptor agonist. The approval came two months after the original Oct. 20 user fee date passed without action.

Saxenda is indicated for chronic weight management, in addition to a reduced-calorie diet and physical activity, in adults with a...

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