European Society of Cardiology

Pharmaceutical-Grade Cannabidiol Shows Promising Cardiac Safety Profile in High-Risk Patients

5 days ago

• A pharmaceutically manufactured cannabidiol formulation demonstrated a favorable cardiac safety profile in patients with cardiovascular risk factors, according to research presented at Heart Failure 2025. • The placebo-controlled trial involving 89 patients showed comparable adverse event rates between GMP-cannabidiol (24.4%) and placebo (22.7%), with no significant differences in cardiac disorders reported in both groups (9%). • These safety findings support ongoing investigations of cannabidiol for inflammatory heart conditions, with results from the ARCHER trial in acute myocarditis expected later in 2025 and the MAVERIC trial in recurrent pericarditis in 2026.

Shingles Vaccine Reduces Cardiovascular Risk by 23% for Up to Eight Years, Study Finds

15 days ago

• A large-scale study of over 1.2 million people found that receiving a shingles vaccine is associated with a 23% lower risk of cardiovascular events, with protection lasting up to eight years. • The protective effect was strongest in men, individuals under 60, and those with unhealthy lifestyles, with a 26% reduction in major cardiovascular events including stroke, heart attack, and death from heart disease. • Researchers suggest the vaccine may prevent cardiovascular complications by reducing shingles-related blood vessel damage, inflammation, and clot formation that can contribute to heart disease.

FDA Clears Roche's Novel Lipoprotein(a) Blood Test with Molar Unit Measurement

4 months ago

• The FDA has granted 510(k) clearance to Roche's Tina-quant® Lipoprotein (a) Gen.2 Molarity assay, marking the first US-approved blood test measuring Lp(a) in molar units. • Approximately 20% of individuals have elevated Lp(a) levels determined by genetics at birth, with the test enabling more accurate cardiovascular risk assessment through particle concentration measurement. • The test will be widely available on Roche's cobas® chemistry systems, supporting the National Lipid Association's recommendation for universal Lp(a) testing to improve cardiovascular risk stratification.

Pulsed Field Ablation and Innovative Therapies Dominate 2024 in Atrial Fibrillation Treatment

4 months ago

• Pulsed-field ablation (PFA) gained prominence with multiple FDA approvals, offering shorter and safer ablation procedures for atrial fibrillation (AF). • The OPTION trial demonstrated that left atrial appendage occlusion (LAAO) with Watchman FLX, when added to catheter ablation, reduces bleeding compared to oral anticoagulants. • The EPIC-CAD trial showed that edoxaban alone is superior to edoxaban plus antiplatelet therapy in AF patients with stable coronary artery disease, reducing adverse events. • New European AF guidelines introduced the AF-CARE pathway, emphasizing comorbidity management, stroke prevention, symptom reduction, and dynamic assessment.

Medtronic Showcases Heart Rhythm Technologies at AF Symposium 2025

4 months ago

At the AF Symposium 2025, Medtronic highlighted its advancements in heart rhythm management, including AI-guided insertable cardiac monitors and pulsed field ablation systems. The DEFINE AFib trial demonstrated the effectiveness of Medtronic's Linq ICMs in predicting AFib-related healthcare needs, while new data on PFA systems offered insights into their clinical utility.

2024 Advances in Lipid Management: A Year of Progress and Setbacks

4 months ago

2024 marked significant progress in lipid management, with notable advancements in the treatment of familial chylomicronemia syndrome (FCS) and lipoprotein(a) (Lp(a)) management. However, the year also saw challenges to the 'HDL hypothesis', highlighting the complexity of lipid-related cardiovascular disease prevention. Key developments included FDA approvals of novel therapies and promising results from clinical trials targeting triglycerides and Lp(a).

AskBio's AB-1005 Gene Therapy for Parkinson's Disease Gains FDA RMAT Designation and Enrolls First Phase II Participants

4 months ago

• AskBio's AB-1005, a gene therapy for Parkinson's disease, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, potentially expediting its development. • The RMAT designation was supported by positive 36-month Phase Ib data, demonstrating a favorable safety profile and encouraging trends in clinical outcome measures. • The Phase II REGENERATE-PD trial, evaluating AB-1005 in moderate-stage Parkinson's, has randomized its first participants across sites in the US, with plans to expand to Europe. • AB-1005 delivers glial cell line-derived neurotrophic factor (GDNF) to promote the survival of dopaminergic neurons, addressing a critical unmet need in Parkinson's treatment.

Bayer Advances Asundexian to Phase 3 Despite Phase 2 Efficacy Misses

5 months ago

• Bayer is proceeding with Phase 3 trials for asundexian, an oral Factor XIa inhibitor, despite it failing to meet primary efficacy endpoints in Phase 2 studies for ischemic stroke and acute myocardial infarction. • The OCEANIC trial program will assess asundexian in up to 30,000 patients with atrial fibrillation, non-cardioembolic ischemic stroke, or high-risk transient ischemic attack. • Phase 2 PACIFIC studies showed asundexian's safety profile was comparable to placebo, without increased bleeding, supporting its continued development despite the lack of efficacy. • Bristol-Myers Squibb and Johnson & Johnson are also developing a Factor XIa inhibitor, milvexian, which showed promising results in secondary stroke prevention, intensifying competition in this drug class.

Coronary Sinus Reducer: An Overlooked Treatment for Stable Angina

5 months ago

A recent review on stable angina treatments has notably omitted the coronary sinus reducer (CSR), a therapy deemed safe and effective for patients with no other treatment options. Despite evidence from randomized trials and real-life registries supporting its efficacy, CSR was not included in the review, sparking discussions among cardiologists about the importance of considering all available therapies for refractory angina.

Ionis' Tryngolza Approved for FCS as Arrowhead's Plozasiran Awaits FDA Review

5 months ago

• The FDA has approved Ionis Pharmaceuticals' Tryngolza (olezarsen) as the first treatment for adults with familial chylomicronemia syndrome (FCS). • Tryngolza, an RNA-targeted therapy, significantly reduces triglyceride levels and the risk of acute pancreatitis in FCS patients when used with a low-fat diet. • Arrowhead Pharmaceuticals' plozasiran, another RNA interference therapeutic for FCS, has been accepted for FDA review, with a decision expected by November 2025. • Clinical trials showed Tryngolza achieved a 57% placebo-adjusted mean reduction in triglycerides at 12 months, while plozasiran demonstrated an 80% median reduction.

CureGene's Novel Antiplatelet Therapy CG-0255 Receives Clinical Trial Approval in China

5 months ago

• CureGene's CG-0255, a novel antiplatelet drug, has received clinical trial approval in China for its injectable formulation, marking a significant step in its global development. • CG-0255 is designed for acute coronary syndrome patients undergoing percutaneous coronary intervention, offering a faster onset and enhanced efficacy compared to oral therapies. • The drug's unique metabolic pathway bypasses challenges related to genetic variations in the CYP2C19 enzyme system, potentially benefiting patients resistant to current treatments. • Phase I clinical trials in the US have shown positive outcomes for both intravenous and oral formulations of CG-0255, presented at major cardiology conferences.

Acoramidis Gains Global Momentum: FDA Approval, EU Recommendation, and Promising Clinical Data

6 months ago

• Acoramidis (Attruby), developed by Stanford Medicine and BridgeBio, receives FDA approval for transthyretin amyloid cardiomyopathy (ATTR-CM) treatment, marking a significant milestone. • The European Medicines Agency's CHMP recommends acoramidis for EU marketing authorization based on positive Phase 3 ATTRibute-CM trial results. • Clinical trials demonstrate acoramidis' efficacy in reducing cardiovascular-related hospitalizations and improving survival rates for ATTR-CM patients. • Bayer and BridgeBio collaborate to commercialize acoramidis, with Bayer holding EU rights and plans for a launch in Europe in early 2025.

Personalized Medicine Biomarkers Market Set to Reach $79.26 Billion by 2034, Driven by Precision Oncology and AI

6 months ago

• The global personalized medicine biomarkers market is projected to grow from $21.95 billion in 2024 to $79.26 billion by 2034, representing a CAGR of 13.7% as demand for precision healthcare solutions increases. • Treatment selection dominates the market with 50.2% share, while oncology leads indication segments at 36.0%, reflecting the critical role of biomarkers in matching patients to targeted cancer therapies. • North America currently holds 52.0% of market share, with the U.S. market alone expected to grow at 15.5% CAGR to reach $40.90 billion by 2034, driven by technological advancements and regulatory support.

Arrowhead Submits Plozasiran NDA to FDA for Familial Chylomicronemia Syndrome

6 months ago

• Arrowhead Pharmaceuticals has submitted an NDA to the FDA for plozasiran, targeting familial chylomicronemia syndrome (FCS), a rare genetic disease with no approved treatments. • The NDA is based on positive Phase 3 PALISADE study results, which showed significant reductions in triglycerides, apolipoprotein C-III, and acute pancreatitis incidence. • Plozasiran demonstrated an 80% median reduction in triglycerides and an 83% reduction in acute pancreatitis risk compared to placebo in the PALISADE trial. • Arrowhead plans to submit applications for plozasiran approval to additional regulatory authorities in 2025, expanding its reach to patients beyond the U.S.

Arrowhead Submits FDA Application for Plozasiran in Familial Chylomicronemia Syndrome

6 months ago

• Arrowhead Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for plozasiran, targeting familial chylomicronemia syndrome (FCS). • The NDA is based on Phase 3 PALISADE study results, which demonstrated significant triglyceride reductions and decreased acute pancreatitis risk. • Plozasiran aims to address the unmet need in FCS, a severe genetic disease with currently no FDA-approved treatments. • The company plans to submit further applications to other regulatory authorities in 2025, expanding plozasiran's potential availability.

Abelacimab Shows Promise in Reducing Bleeding Risk for Atrial Fibrillation Patients

6 months ago

• The AZALEA-TIMI 71 trial demonstrated that abelacimab significantly reduces bleeding events compared to rivaroxaban in atrial fibrillation patients. • Abelacimab, a Factor XI inhibitor, showed a 62% to 69% reduction in major or clinically relevant non-major bleeding compared to rivaroxaban. • Gastrointestinal bleeding, a common issue with current anticoagulants, was almost eliminated with abelacimab treatment. • A Phase III trial (LILAC-TIMI 76) is underway to assess abelacimab's efficacy in preventing stroke in high-risk patients ineligible for current anticoagulants.

Finerenone sNDA Submitted to FDA for Heart Failure with Preserved Ejection Fraction

6 months ago

• Bayer has submitted a supplemental New Drug Application (sNDA) to the FDA for finerenone to treat heart failure patients with LVEF ≥40%. • The sNDA is based on the Phase III FINEARTS-HF trial, which demonstrated a 16% reduction in cardiovascular death and heart failure events. • Finerenone is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) already approved for chronic kidney disease in type 2 diabetes. • If approved, finerenone could address a significant unmet need in heart failure patients with mildly reduced or preserved ejection fraction.

Milestone Pharmaceuticals Gains New Patent for Etripamil, Prepares for Potential Launch

6 months ago

• Milestone Pharmaceuticals received a Notice of Allowance from the USPTO for a new patent covering the repeat dose regimen of etripamil nasal spray, extending potential IP protection to July 2042. • The patent supports the New Drug Application (NDA) for CARDAMYST™ (etripamil) currently under FDA review, with a PDUFA target date of March 27, 2025. • Milestone is actively preparing for a mid-2025 commercial launch of CARDAMYST for Paroxysmal Supraventricular Tachycardia (PSVT), pending FDA approval. • A Phase 3 trial of etripamil nasal spray for Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) is planned to commence in the first half of 2025.

BridgeBio Reports Positive Pipeline Progress and Q3 2024 Financial Results

6 months ago

• BridgeBio's acoramidis shows positive Phase 3 results for ATTR-CM, with an FDA PDUFA date set for November 29, 2024, and potential $500M milestone payment upon approval. • The company anticipates three Phase 3 readouts in 2025 and has completed screening for the CALIBRATE trial of encaleret and enrollment for the FORTIFY trial. • Infigratinib receives Breakthrough Therapy Designation for achondroplasia, highlighting advancements in BridgeBio's pipeline for genetic diseases. • BridgeBio's Q3 2024 financial results include $2.7M in revenue and a net loss of $162.0M, with a cash position of $405.7M.

GMRx2 Triple Combination Pill Shows Promising Phase III Results for Hypertension Treatment

7 months ago

• A Phase III trial published in The Lancet reveals GMRx2, a novel triple combination pill, significantly reduces blood pressure compared to dual therapies. • GMRx2 half-dose achieved a 63% clinic BP control rate, while the standard dose reached 74%, surpassing dual combinations (53-61%) in hypertension management. • The triple combination therapy aligns with the latest European Society of Cardiology guidelines, advocating for increased use of combination therapies for hypertension. • George Medicines has submitted a New Drug Application to the FDA, potentially making GMRx2 the first approved triple combination for initial hypertension treatment.