FDA Approves Amgen Heart Failure Drug

The FDA on Wednesday approved ivabradine (Corlanor), Amgen’s new heart failure drug. The drug has been available for several years in Europe, where it is sold by Servier under the brand names of Corlentor and Procoralan. Ivabradine was approved for the reduction of hospitalization from worsening heart failure. … Click here to read the full post on Forbes.    …

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Cardiology Drugs Of The Year: New, Old, And Not-So-Funny

New Drug Of The Year: LCZ696 from Novartis Old Drug of the Year: Ezetimibe Not-So-Funny Drug of the Year: Ivabradine … Click here to read the full post on Forbes.  …

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European Review Confirms Increased Risk with Ivabradine

Following a review provoked by troubling findings that emerged from a large clinical trial, the European Medicines Agency (EMA) is making several recommendations intended to lower the risk of heart problems linked to the heart-rate-lowering drug ivabradine. The drug is marketed by Servier in Europe under the brand names of Corlentor and Procoralan and is indicated for…

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SIGNIFY Trial Provokes Sound And Fury Over Controversial Servier and Amgen Drug

The controversial drug ivabradine just got a little more controversial. The drug, which is marketed by Servier under the brand names of Corlentor and Procoralan, is available in Europe and elsewhere and is used for the treatment of heart failure and stable angina. The drug is not available in the US, but it is under development by Amgen for a heart…

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Silencio! Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference

Investigators of the much-anticipated and controversial SIGNIFY trial have told the European Society of Cardiology leadership that they will not participate in a previously scheduled press conference on Sunday at the society’s main meeting in Barcelona. But they say they will present the main results of their trial at a Hot Line session later in the afternoon….

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Sharp Scrutiny From European Medicines Agency Of Amgen And Servier Heart Drug

There may be trouble on the horizon for ivabradine, a heart drug marketed by Servier under the brand names of Corlentor and Procoralan. The drug is widely available in Europe and elsewhere, though it is not available in the US, where it is under development by Amgen. Although it hasn’t been widely noticed– I can find no other…

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FDA Grants Fast Track Status To Amgen Heart Failure Drug

Amgen announced yesterday that its new chronic heart failure drug ivabradine had been granted fast track status by the FDA. The company said the fast track designation, which is for drugs that treat serious conditions and fill an umet medical need, will aid the development and speed the review of the drug. … Click here to read the…

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