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Genzyme/Isis’ Long-Awaited Kynamro NDA May Allay Liver Toxicity Fears

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Sanofi’s Genzyme business unit and Isis submitted an NDA for mipomersen, a first-in-class cholesterol-lowering antisense drug, in an orphan population of high-risk patients with a rare genetic cardiovascular disease – with an assist from three Phase III clinical trials from other, larger, high-risk populations, to help inform regulators.

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Kynamro Liver Safety Data Faces FDA Advisory Committee Gauntlet

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Genzyme/Isis On Track To Submit Cholesterol Drug Mipomersen In 1H 2011

Mipomersen, Genzyme/Isis Pharmaceuticals' second-generation antisense drug for severe high cholesterol, is four for four in terms of collecting positive outcomes in Phase III trials. But in addition to lowered cholesterol, patients in all of those studies had elevated liver enzymes, leaving open the question whether regulators will consider the side effect a manageable trade off for filling an unmet medical need

Making The Most Of ACOs: How Biopharma Is Adapting To New Customer Segment

ACOs have been one of the most hyped innovations in the US health care sector this decade. The buzz may be overdone, but ACOs are now established as a different—and confusing—new customer segment for pharma. How is industry adjusting?


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