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Glycemic Control Not Enough For New Diabetes Drugs, Roche Exec Says

Executive Summary

Sponsors must move beyond glycemic control if they want any new therapy for type 2 diabetes to be commercially viable, according to a Roche executive.

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Development of dual PPAR agonist aleglitazar terminated due to fractures, renal impairment and heart failure reported in the AleCardio study, leaving another hole in Roche’s cardiovascular/metabolic pipeline.

Roche Drops Aleglitazar In Another Cardiology/Metabolics Setback

Development of dual PPAR agonist aleglitazar terminated due to fractures, renal impairment and heart failure reported in the AleCardio study, leaving another hole in Roche’s cardiovascular/metabolic pipeline.

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While industry mega-mergers occupied readers in 2009, the focus in 2010 shifted toward several evolving policy concerns and their impact on company strategy. Among these, more companies are looking at the opportunity for biosimilars created by the health care reform law's provision of a legal framework for product approval. But early analyses suggest that there is still a lot of work to do as FDA develops a guideline for industry on an abbreviated approval pathway.

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