News | 10.21.19
FDA Approves AstraZeneca's Farxiga for Patients With Type 2 Diabetes
October 21, 2019—AstraZeneca announced that the FDA has approved Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
News | 10.17.19
NICE Publishes Guidance on Rivaroxaban for Preventing Atherothrombotic Events in Patients With CAD or PAD
October 17, 2019—The United Kingdom’s National Institute for Health and Care Excellence (NICE) has published its technology appraisal guidance (TA607) on evidence-based recommendations on rivaroxaban (Xarelto; Bayer AG, marketed in the United States by the Janssen Pharmaceutical Companies of Johnson & Johnson) for preventing atherothrombotic events in adults with coronary artery disease (CAD) or peripheral artery disease (PAD).
News | 10.14.19
FDA Approves Xarelto for VTE Prevention in Acutely Ill Medical Patients
October 14, 2019—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Xarelto (rivaroxaban) for the prevention of venous thromboembolism (VTE) in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.
News | 09.09.19
Recardio Begins Phase 2 Trial of Dutogliptin in Early Recovery Postmyocardial Infarction
September 9, 2019—Recardio Inc., a life science company developing regenerative therapies for cardiovascular diseases, announced that its phase 2 study of dutogliptin in combination with filgrastim in early recovery postmyocardial infarction is now enrolling and recruiting in multiple European and United States centers.
News | 08.27.19
Study Published on Anticoagulation After Surgical or Transcatheter Aortic Valve Replacement
August 27, 2019—Findings from a study aimed to assess the impact of anticoagulation after bioprosthetic aortic valve replacement (AVR)—either surgical (SAVR) or transcatheter (TAVR)—on valve hemodynamics and clinical outcomes were published by Tarun Chakravarty, MD, et al in Journal of the American College of Cardiology (JACC) (2019;74:1190–1200).
News | 08.20.19
AstraZeneca's Farxiga Meets Primary Endpoint in DAPA-HF Trial
August 20, 2019—AstraZeneca announced the results from its landmark phase 3 DAPA-HF trial, showing that the company's Farxiga (dapagliflozin, a sodium-glucose cotransporter 2 [SGLT2] inhibitor) met the primary composite endpoint with a statistically significant and clinically meaningful reduction of cardiovascular death or worsening heart failure (defined as hospitalization or urgent heart failure visit) compared with placebo.
News | 07.22.19
Meta-Analysis Shows Midterm Mortality Benefit of Statin Therapy After TAVR
July 22, 2019—A meta-analysis of available studies was performed to determine whether statin (hydroxymethylglutaryl-CoA reductase inhibitor) therapy is associated with better midterm survival after transcatheter aortic valve replacement (TAVR).
News | 05.29.19
FDA Grants Priority Review for Supplemental NDA for a Cardiovascular Risk Reduction Indication for Amarin's Vascepa
May 29, 2019—Amarin Corporation plc announced that its supplemental new drug application (sNDA) for Vascepav (icosapent ethyl) capsules has been accepted for filing and granted Priority Review designation by the FDA.
News | 03.26.19
TREAT Trial Evaluates Safety and Efficacy of Ticagrelor After STEMI
March 26, 2019—The TREAT trial demonstrated that ticagrelor's efficacy and safety was equivalent to clopidogrel in data presented at the American College of Cardiology (ACC) 68th Annual Scientific Session, held March 16–18 in New Orleans, Louisiana.
News | 03.19.19
Full Results Presented From Phase 1 Trial of PhaseBio's PB2452 Ticagrelor Reversal Agent
March 19, 2019—PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced that results from the phase 1 clinical trial of PB2452, a novel reversal agent for the antiplatelet drug ticagrelor, were presented at the American College of Cardiology's 68th annual scientific session being held March 16–18 in New Orleans, Louisiana.
News | 11.10.18
REDUCE-IT Trial Evaluates Amarin's Vascepa for Reduction in MACE
November 10, 2018—Amarin Corporation plc announced that the results from the REDUCE-IT trial of cardiovascular outcomes of the company's Vascepa (icosapent ethyl) were presented as a late-breaking clinical trial at the American Heart Association (AHA) 2018 Scientific Sessions of held November 10–12 in Chicago, Illinois.
News | 11.10.18
AHA and ACC Publish 2018 Cholesterol Guidelines
November 10, 2018—The American Heart Association (AHA) and American College of Cardiology (ACC) announced the publication of 2018 cholesterol guidelines recommending more personalized risk assessments and new cholesterol-lowering drug options for those at highest risk for cardiovascular disease.
News | 10.11.18
FDA Approves Indication for Xarelto to Reduce Risk of Major CV Events in Patients With Chronic CAD or PAD
October 11, 2018—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction, and stroke, in those with chronic coronary or peripheral artery disease (CAD/PAD).
News | 05.15.18
Medicure Launches Zypitamag Statin in the United States
May 15, 2018—Medicure Inc. recently announced that its Zypitamag (pitavastatin magnesium) tablets are now available in the United States, where they are sold through the company's subsidiary, Medicure Pharma, Inc. Zypitamag was approved as a statin (HMG-CoA reductase inhibitor) medication by the US Food and Drug Administration in July 2017.
News | 05.14.18
FDA Approves Portola Pharmaceuticals' Andexxa for the Reversal of Factor Xa
May 14, 2018—Portola Pharmaceuticals, Inc. recently announced that the US Food and Drug Administration (FDA) has approved the company's Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo), an antidote indicated for patients treated with rivaroxaban and apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
News | 03.13.18
Analysis From ACCELERATE Trial Evaluates ADCY9 Genetic Variants and Cardiovascular Outcomes With Evacetrapib in Patients With High-Risk Vascular Disease
March 12, 2018—Steven E. Nissen, MD, presented findings from an analysis of the ACCELERATE trial of ADCY9 genetic variants and cardiovascular outcome with evacetrapib in a featured clinical research session at the American College of Cardiology's (ACC) 67th annual scientific session held March 10-12 in Orlando, Florida. The study was simultaneously published online in Journal of the American Medical Association (JAMA): Cardiology.
News | 03.11.18
Dabigatran Shown to Reduce Major Cardiovascular Complications in Patients With Myocardial Injury After Noncardiac Surgery
March 11, 2018—Treatment with the anticoagulant drug dabigatran significantly reduced the risk of death, heart attack, stroke, and other heart or blood vessel complications among patients who were at elevated risk for these events due to heart damage that occurred after major noncardiac surgery.