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LIB Therapeutics’ Cholesterol Lowering Med Lerodalcibep Receives FDA BLA Acceptance

XTalks

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. Over 2,400 patients have continued in the 72-week open-label extension trial.

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Novartis tries to rescue stalled inclisiran filing with FDA

pharmaphorum

The small interfering RNA (siRNA) therapy has already been approved in Europe as Leqvio , and the FDA’s rejection was not caused by any issues with its efficacy or safety, according to Novartis. 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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FDA rejects Novartis’ cholesterol drug after factory inspection issue

pharmaphorum

A first-in-class treatment discovered by Alnylam and then licensed to The Medicines Company, the drug is being developed for treatment for hyperlipidaemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. billion late last year.

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Novartis Leqvio®* (inclisiran) analyses show effective and sustained LDL-C reduction.

The Pharma Data

Results were presented at the ESC Congress 2021, organized by the European Society of Cardiology (ESC). As the first and only small interfering RNA to provide effective and sustained LDL-C reduction, Leqvio helps manage a critical cardiovascular risk factor for ASCVD. It is currently under review by the U.S.

RNA 52
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Novartis new analysis shows high consistency in lowering LDL-C in individual response with investigational inclisiran

The Pharma Data

Presented at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, the analysis evaluated the efficacy and tolerability of inclisiran on top of a maximally tolerated dose of statins, in two studies of more than 2,300 patients (of which 1,164 were on inclisiran) from the Phase III trials.

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Late in 2022, AbbVie partnered with HotSpot Therapeutics and announced an exclusive worldwide collaboration and option to license agreement for their interferon regulatory factor 5 (IRF5) inhibitor program for autoimmune disease treatment. This partnership will expand the company’s immunology pipeline. Veklury generated a revenue of $3.91

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