Aegerion Warns About Negative Impact Of DOJ Investigation

Earlier this week in its annual report Aegerion Pharmaceuticals provided an update on its ongoing problems with the FDA and the Department of Justice. As previously reported here and on The Street and on CNBC, the company landed in hot water with the FDA last year after its CEO made a series of off-label statements on the CNBC Fast Money show. (The company’s only product, Juxtapid…

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Justice Department Investigating Aegerion Over Marketing Of New Cholesterol Drug

Aegerion Pharmaceuticals disclosed today that it is being investigated by the US Department of Justice over its marketing of Juxtapid (lomitapide). The drug was approved in December 2012 to help further lower cholesterol in patients with homozygous familial hypercholesterolemia. The drug costs $250,000 a year. The approval came with a box warning about the risk of hepatotoxicity and a strict Risk Evaluation…

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Study Casts Doubt On Value Of Genetic Testing For Familial Hypercholesterolemia

A new study published online in the Lancet suggests that one of the main screening plans that relies on genetic tests will fail to identify a substantial portion of people with familial hypercholesterolemia. Investigators from the UK and Belgium analyzed DNA from several cohorts of FH and non-FH patients. Their chief finding was that a large percentage…

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Promising Phase 1 Results For New Monoclonal Antibody to PCSK9

Promising results from very early studies with an experimental new cholesterol-lowering drug, a monoclonal antibody to PCSK9, have been published in the New England Journal of Medicine. Evan Stein and colleagues report the results of two single-dose studies in which the drug, REGN727, was administered intravenously and subcutaneously to healthy subjects. In a third, randomized, placebo-controlled, dose-ranging…

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