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UK regulator backs Amarin’s cardiology drug Vazkepa

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Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients.

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LIB Therapeutics’ Cholesterol Lowering Med Lerodalcibep Receives FDA BLA Acceptance

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LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population. This gives lerodalcibep an edge to approved PCSK9 inhibitors.

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Rumour mill says AstraZeneca may be eyeing a takeover of Mereo

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The UK-based but US-listed biotech licensed rights to AZ’s orally-active neutrophil elastase inhibitor alvelestat for the rare disease alpha-1 antitrypsin deficiency (AATD) five years ago, and has since advanced the project into a phase 2 trial which is due to read out in the second half of this year.

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Bayer sells testosterone drug rights to Grünenthal for €500m

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The legacy product now lies outside Bayer’s core areas of cardiology, oncology, haematology, ophthalmology, women’s health and radiopharmaceuticals, and the funds raised from the sale will support the “ongoing transformation of Bayer’s pharma business to focus on key areas of future medical innovation”, said the company.

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Is cardiovascular disease a ‘pandemic hiding in plain sight’?

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But Dr Craig Granowitz, chief scientific officer of cardiology drug developer Amarin, says that this is only the tip of the iceberg when it comes to the devastating impact of CVD on global populations. “In But one of the biggest issues in changing people’s expectations and improving outcomes is “apathy”, he says.

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Novartis tries to rescue stalled inclisiran filing with FDA

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Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. Novartis added inclisiran to its pipeline after buying The Medicines Company, which had licensed the drug from Alnylam, for $9.7

RNA 105
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Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal

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Novo Nordisk – which is already active in stem cell therapies with a candidate in early development for type 1 diabetes – is on the hook for up to $598 million in total licensing and milestone payments plus royalties on sales if HS-001 reaches the market.

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