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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. This gives lerodalcibep an edge to approved PCSK9 inhibitors.

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Rumour mill says AstraZeneca may be eyeing a takeover of Mereo

pharmaphorum

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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Novartis tries to rescue stalled inclisiran filing with FDA

pharmaphorum

Novartis added inclisiran to its pipeline after buying The Medicines Company, which had licensed the drug from Alnylam, for $9.7 billion in 2019, and will be hoping for a swift response from the FDA to get the programme back on track and recoup its investment.

RNA 105
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MorphoSys, Incyte receive FDA Ok for Monjuvi; Siemens Healthineers set to buy Varian; Immunic’s IMU-838 promising results

Delveinsight

Not long ago, the companies inked an oncology pact to develop and commercialize MorphoSys’ anti-CD19 antibody Monjuvi jointly. Siemens Healthineers, formed as a result of spin-off in 2018, plans to increase its presence in oncology, neurology as well as cardiology domain. Billion deal in a thirst to grow in the cancer market.

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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.

Drugs 52
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AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

The Pharma Data

Alexion ‘s franchise includes Soliris (eculizumab), a first-in-class anti-complement component 5 (C5) monoclonal antibody. More recently, Alexion launched Ultomiris (ravulizumab), a second-generation C5 monoclonal antibody with a more convenient dosing regimen. The complement cascade is pivotal to the innate immune system.

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Alexion Reports Third Quarter 2020 Results

The Pharma Data

ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Enrollment is underway in two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S.

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