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UK regulator backs Amarin’s cardiology drug Vazkepa

pharmaphorum

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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Integrating Bioanalytical Automation, Biomarkers, Pharmacogenomics, & Cost-Effective Strategies

Worldwide Clinical Trials

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential?

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AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

It can be used as a monotherapy or along with cholesterol-lowering medicines. Participants treated with LODOCO had a 31% reduction in the overall risk of cardiovascular death, spontaneous myocardial infarction or ischaemic stroke when added to statins and other cardiology prevention therapies, compared to those treated with placebo.

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Developing a digital marker for coronary artery disease

Medical Xpress

Using machine learning and clinical data from electronic health records, researchers at the Icahn School of Medicine at Mount Sinai in New York constructed an in silico, or computer-derived, marker for coronary artery disease (CAD) to better measure clinically important characterizations of the disease.

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LUCA Science Announces Joint Research With Division of Cardiology, Field of Internal Medicine, Nagoya University Graduate School of Medicine on the Development of Mitochondrial Therapy for Myocardial Infarction (Cardiac Ischemic-reperfusion Injury)

BioTech 365

LUCA Science Announces Joint Research With Division of Cardiology, Field of Internal Medicine, Nagoya University Graduate School of Medicine on the Development of Mitochondrial Therapy for Myocardial Infarction (Cardiac Ischemic-reperfusion Injury) LUCA Science Announces Joint Research With Division of Cardiology, … Continue reading →

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BridgeBio’s Attruby (Acoramidis): A New, More Potent TTR Stabilizer for ATTR-CM

XTalks

A Marketing Authorization Application has been submitted to the European Medicines Agency (EMA), with a decision anticipated in 2025. BridgeBio is also working to address gaps in ATTR-CM diagnosis through its TRACE-AI Network Study , a collaboration with the Cardiovascular Data Science Lab (CarDS Lab) at the Yale School of Medicine.