cardiovascular event News
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Study reveals elevated risk of cardiovascular disease in young women who had gestational diabetes during pregnancy
New research published in Diabetologia (the journal of the European Association for Study of Diabetes [EASD]) shows that, in women who develop gestational diabetes (GDM) during pregnancy, the risk of cardiovascular disease (CVD) in the years following childbirth is doubled compared to women who do not develop GDM. This increased risk remains even if women who had GDM do not go on to develop full ...
By Siemens AG
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oxLDL as a predictive marker
The study by Sommariva E et al. (2021) demonstrates that oxLDL can be used as a predictive marker for the progression of arrhythmogenic cardiomyopathy (ACM). Based on the cut-off of 86 ng/mL, patients with ACM were divided into 2 groups and further studied. Levels < 86 ng/mL included among other things a lower risk of cardiovascular events (such as ventricular tachycardia, ventricular ...
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Circassia Announces FDA Approval of Tudorza Supplemental New Drug Application
Data showing reduction in COPD exacerbations and no increase in major cardiovascular events vs placebo added to label – – Tudorza® is the only product in its class with these data in the label Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US ...
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Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes
CHMP opinion is based on the results from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), which included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D The positive data from FIGARO-DKD demonstrated that finerenone significantly reduced the ...
By Bayer AG
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Circassia Announces Publication of Tudorza Phase IV ASCENT Study in the Journal of the American Medical Association
Oxford, UK – 8 May 2019: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the full publication of the Tudorza® phase IV ASCENT study in the prestigious Journal of the American Medical Association*. The ASCENT study was conducted in patients with ...
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Soundbite Medical Solutions Receives FDA 510(k) Clearance for the SoundBite® Crossing System – Peripheral (14P)
Soundbite announces the company has received Food and Drug Administration (FDA) 510(k) clearance for the SoundBite® Crossing System - Peripheral (SCS-P) with the 0.014” Active Wire (14P). The SoundBite Crossing System – Peripheral (14P) is a recanalization tool, designed to help physician’s placement of conventional guidewires or treatment devices in the intraluminal space ...
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Circassia Announces Positive Data Presented at 2018 American Thoracic Society Conference from Tudorza Phase IV and Duaklir Phase III Studies
Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the presentation of positive clinical data from the Tudorza® Pressair® phase IV ASCENT study and Duaklir® Pressair® phase III AMPLIFY study at the American Thoracic Society (ATS) 2018 International ...
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Circassia Announces Publication of Tudorza Phase IV ASCENT Study in the Journal of the American Medical Association
Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the full publication of the Tudorza® phase IV ASCENT study in the prestigious Journal of the American Medical Association*. The ASCENT study was conducted in patients with moderate-to-very severe chronic obstructive ...
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Circassia Announces FDA Approval of Tudorza Supplemental New Drug Application
Oxford, UK – 29 March 2019: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US Food and Drug Administration (FDA) has approved Tudorza®’s supplemental New Drug Application (sNDA) for the inclusion of unique new clinical data in the product’s ...
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Kerendia (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes
European Commission granted approval for a label update to extend the indication of Kerendia™ to early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study FIGARO-DKD included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD ...
By Bayer AG
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Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes
Kerendia is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) The approval is based on the results of the Phase III FIDELIO-DKD study investigating the efficacy and safety of Kerendia on kidney and CV outcomes in ...
By Bayer AG
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Galapagos to present encouraging initial data from FILOSOPHY real-world arthritis study at ACR Convergence 2022
Galapagos NV (Euronext & NASDAQ: GLPG) will present new data on filgotinib at the American College of Rheumatology (ACR) Convergence 2022 meeting taking place in Philadelphia, Pennsylvania from 10-14 November 2022. Dr. Walid Abi-Saab, Chief Medical officer, at Galapagos said, “We are excited to present data at ACR which highlights our continued commitment to patients and the healthcare ...
By Galapagos NV
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CVRx Receives MR-Conditional Labeling Approval for its Barostim Heart Failure System
MINNEAPOLIS, MAY 9,2022 - CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure, has received U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR) conditional labeling for its Barostim System. The Barostim System now includes instructions to allow for safe MRI scans of the head and ...
By CVRx
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Shifa Launches with Seed Financing to Address Cardiovascular Disease by Developing Orally Bioavailable Drugs for the Treatment of Dyslipidemia - PharmiWeb.com
MALVERN, Pa.--(BUSINESS WIRE)--#Cardiovascular--Shifa Biomedical Corporation (Shifa), a drug discovery company developing an oral small molecule PCSK9/low density lipoprotein-cholesterol receptor (LDLR) antagonist, P-21, to treat dyslipidemia, today announced their launch with a seed investment from Xontogeny, LLC to advance their lead program through IND-enabling research. “We are excited ...
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Circassia Announces Submission of Duaklir New Drug Application and Tudorza Supplemental New Drug Application in the United States
Duaklir® NDA for treatment of chronic obstructive pulmonary disease (COPD) Tudorza® sNDA for inclusion of COPD exacerbation reduction and cardiovascular safety data in label Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the submission of a New Drug ...
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Kerendia (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study
U.S. Food and Drug Administration (FDA) granted label update for Kerendia (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV ...
By Bayer AG
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Circassia Announces Duaklir New Drug Application (NDA) and Tudorza Supplemental NDA Accepted for Review by FDA
Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces that the United States Food and Drug Administration (FDA) has confirmed it has completed its validation for completeness, and accepted for filing and review, the previously submitted Duaklir® New Drug Application ...
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Study Published in JAMA Finds Hospital Availability of TCAR Associated with an Improvement in Overall Outcomes for Carotid Revascularization
Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced positive results from a comparative-effectiveness study have been published in JAMA Network Open. The study found the availability of TCAR at a hospital was associated with a significant decrease in the likelihood of major adverse cardiovascular events (MACE), a ...
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Elucid Presents Results of the EVAPORATE Study at ESC Preventive Cardiology 2021 Late Breakers
BOSTON–(BUSINESS WIRE)–Elucid, a medical technology company developing AI software for physicians to optimize the treatment of patients with known or suspected vascular disease, announced that first author and Elucid founder Andrew Buckler presented findings today from the EVAPORATE (Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking ...
By Elucid
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MagicTouch SCB Granted ‘Breakthrough Device Designation’ for the treatment of Small Coronary Artery Lesions.
Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed indication for use includes “The ...
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