Thursday, October 30, 2014

Novo Nordisk more cautious on timing of U.S. Tresiba launch

COPENHAGEN (Reuters) - Novo Nordisk is more cautious in its assessment of when it would launch its Tresiba diabetes drug in the United States, a critical growth driver for the future, according to statements it made in its quarterly report. The U.S. Food and Drug Administration (FDA) refused in February 2013 to approve Tresiba, a long-acting insulin drug, until Novo provided additional tests for potential heart risks. In August, the company said it expected to be able to submit an interim analysis to the FDA during the first half of 2015, leading to a potential launch at the start of 2016. ...



via Health News Headlines - Yahoo News http://ift.tt/1wIcsTP

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