Court Decision In Patent Battle Threatens PCSK9 Drug

—-One analyst thinks the decision might take Praluent off the market. A jury’s decision last week in a patent case might possibly lead to the removal of one of the new PCSK9 inhibitor cholesterol lowering drugs from the US market, according to a Wall Street analyst who has been closely following the case. Amgen, which…

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First Outcomes Trial Results For PCSK9 Drugs Will Come In 2016

In less than a year we may know a whole lot more about the PCSK9 inhibitors than we do now. Since the approval earlier this year of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Regeneron and Sanofi) critics and benefit managers have recommended strict limitations on use of the drugs because of the absence of evidence showing clinical benefit….

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Amgen Denies Rumors About PCSK9 Inhibitors (Updated)

(Updated) Amgen says there is no truth to the rumor that the FDA is investigating post-marketing reports of serious brain infections in patients taking PCSK9 inhibitors. The Amgen statement was in response to this anonymous post on CafePharma: “The FDA informed Amgen and Regeneron today that there have been a number of post marketing reports…

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Cholesterol Wars: The Reimbursement Battle Begins

(Updated) The next stage of the cholesterol wars has officially started. With the recent approval of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Sanofi and Regeneron) the big immediate question everybody wanted answered was how the battle to pay for these expensive drugs (the wholesale acquisition cost is more than $14,000/year for both drugs) would shape…

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FDA Approval Of Second PCSK9 Inhibitor Expected Soon

The FDA has until Thursday, August 27 to make its decision about Repatha (evolocumab), Amgen’s much anticipated cholesterol lowering PCSK9 inhibitor. The drug is widely expected to gain approval. Last month the FDA approved Praluent (alirocumab), Sanofi’s and Regeneron’s similar drug. Beyond approval the major questions that should be answered this week concern the drug’s label…

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