Acute coronary syndrome

Avenacy Announces Launch of Eptifibatide for Injection in the U.S. Market

Retrieved on: 
Lundi, avril 29, 2024
Biotechnology, FDA, Health, Pharmaceutical, Cardiology, Acute coronary syndrome, Percutaneous coronary intervention, Food, Death, PCI, ACS, Patient, Myocardial infarction, Multimedia, Pharmaceutical industry

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Eptifibatide for Injection in the United States as a therapeutic equivalent generic for Integrilin® for Injection (Eptifibatide) approved by the U.S. Food and Drug Administration.

Key Points: 
  • Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Eptifibatide for Injection in the United States as a therapeutic equivalent generic for Integrilin® for Injection (Eptifibatide) approved by the U.S. Food and Drug Administration.
  • Eptifibatide for Injection is indicated for use in acute coronary syndrome (ACS) and percutaneous coronary intervention (PCI).
  • View the full release here: https://www.businesswire.com/news/home/20240429526438/en/
    Avenacy’s Eptifibatide for Injection is available as a 75 mg/100 mL single-dose vial.
  • Avenacy will begin shipping Eptifibatide for Injection to wholesale partners this week.

Johnson & Johnson to Showcase its Broad Scientific Leadership and Latest Innovations to Combat Cardiovascular Disease at ACC.24

Retrieved on: 
Jeudi, avril 4, 2024
Cardiology, Abstract, Rivaroxaban, Cardiovascular disease, Worldwide, Peripheral artery disease, Health, Atrial fibrillation, Risk, Patient, Knowledge, PAD, Stroke, Research, Death, Statistics, American College, Danger, Johnson & Johnson, Acute coronary syndrome, Pharmaceutical industry

NEW BRUNSWICK, N.J., April 4, 2024 /PRNewswire/ -- Johnson & Johnson announced today that clinical and real-world evidence from its cardiovascular portfolio will be featured at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) taking place April 6-8, 2024, in Atlanta, Georgia. Eleven abstracts, including five oral presentations, will showcase data from Company-sponsored studies demonstrating therapeutic benefit of breakthrough medicines, such as XARELTO® (rivaroxaban), and interventional technologies, such as those from Abiomed® and Biosense Webster®, to help treat cardiovascular diseases, including atrial fibrillation (AF) and peripheral artery disease (PAD).

Key Points: 
  • "At ACC.24, we look forward to sharing the latest research and innovation from our broad portfolio, including XARELTO®, to equip clinicians and researchers with knowledge and insights that can help transform cardiovascular care for all."
  • Johnson & Johnson is committed to elevating the standard of care in cardiovascular diseases and unlocking the potential of medicines and solutions of tomorrow.
  • Several data presentations at ACC.24 demonstrate how the Company is improving outcomes for people living with cardiovascular disease, including older adults and other patient populations often considered hard to treat.
  • The data we're presenting at ACC.24 demonstrate how we're continuing to deliver on our commitment," said Tim Schmid, Executive Vice President and Worldwide Chairman, Johnson & Johnson MedTech.

Polymedco announces US FDA clearance of the PATHFAST high-sensitivity cardiac troponin I (hs-cTnI-II) test as an aid in the diagnosis of myocardial infarction

Retrieved on: 
Mercredi, mars 27, 2024
Diagnosis, FACC, EDS, Myocardial infarction, Plasma, Acute coronary syndrome, Patient, Splenic infarction, Chest pain, Emergency, Length of stay, Patient satisfaction, ED, FDA, ECG, Food, Medical device

CORTLANDT MANOR, N.Y., March 27, 2024 /PRNewswire/ -- The PATHFAST hs-cTnI-II, a breakthrough high-sensitivity troponin assay developed for the PATHFAST Biomarker Analyzer, received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new test will facilitate the accurate, rapid diagnosis of myocardial infarction at the point of care. The PATHFAST point-of-care platform offers a comprehensive menu of tests that bring central lab-quality diagnostic results closer to the clinician and patient, saving valuable time when evaluating patients with potentially life-threatening conditions.

Key Points: 
  • This new test will facilitate the accurate, rapid diagnosis of myocardial infarction at the point of care.
  • PATHFAST hs-cTnI-II becomes first and only hs-cTn test cleared for point-of-care use in the United States.
  • When patients enter the ED with a suspected heart attack, doctors typically use a troponin blood test to aid in their diagnosis.
  • "Both speed and quality in high-sensitivity cardiac troponin testing are essential in the emergency department for safe and timely disposition of patients.

RWJBarnabas Health and Rutgers Health to Showcase Breakthrough Cardiology Data at the American College of Cardiology Scientific Session & Expo

Retrieved on: 
Lundi, mars 25, 2024
CMR, TME, FACC, National Health Interview Survey, Research, Obesity, Hypertension, MRI, Cooperman Barnabas Medical Center, Facial muscles, HIV, Diabetes, Risk, National Health, Patient, Stroke, RWJBarnabas Health, Community Medical Center, Mortality, Aortic stenosis, American College of Cardiology, Telehealth, Faculty, New Jersey Medical School, NHIS, Abstract, American College, Smoking, LVDD, Rutgers University, Division, TAVR, Collection, Jersey City Medical Center, ACC, YPLL, Acute coronary syndrome, Health, Meta-analysis, Dietary supplement

WEST ORANGE, N.J., March 25, 2024 /PRNewswire/ -- Physician-scientists from RWJBarnabas Health and Rutgers Health will present an extensive portfolio of innovative cardiovascular data from their clinical research program at the American College of Cardiology's (ACC) Annual Scientific Session & Expo in Atlanta, Georgia on April 6 to 8, 2024. A total of 59 abstracts have been accepted, composed of data evaluating and educating on risk factors, treatment options and ongoing research advances to improve cardiovascular care and outcomes for patients.

Key Points: 
  • A total of 59 abstracts have been accepted, composed of data evaluating and educating on risk factors, treatment options and ongoing research advances to improve cardiovascular care and outcomes for patients.
  • RWJBarnabas Health cardiac centers of excellence are nationally recognized for patient care and superior outcomes, including being named as one of Becker's top 100 Great Heart Programs in the country and recognized by American College of Cardiology as a Proven Quality Program.
  • Prior studies suggest that distinct patient subgroups with aortic stenosis may experience left ventricular systolic and diastolic dysfunction before the development of severe AS.
  • The study included patients who had received an angiogram done within 14 days of the CMR.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Mercredi, février 14, 2024
Leptin, PD, Metabolism, Toxicity, Body composition, Ciprofloxacin, Clinical Pharmacokinetics, Water, LBW, Perfusion, LBM, Canadian International Council, AUC, PLOS One, Bariatric surgery, Clopidogrel, CYP, Breast, Health, DNA-binding protein, BMC Public Health, Pharmacology, BMI, CRP, Pharmaceutical Research (journal), Organ, Draft, Guideline, Bypass surgery, WHO, Ageing, INT, Pharmacokinetics, Liver, Bioavailability, Chronic liver disease, Human, Incidence, Committee, Absorption, TBW, Cardiovascular disease, Anatomy, CYP2C19, PBPK, Cmax, Factorization of polynomials, European, Lancet, CHMP, Journal, NASH, Pharmacotherapy, Adipose tissue, Non-alcoholic fatty liver disease, Journal of Clinical Investigation, Medication package insert, Overweight, NPS MedicineWise, Permeability, Benzodiazepine, Meta-analysis, Liver disease, Half-life, Acetylcholine, Ciclosporin, AAG, Kinetics, Midazolam, Kidney, Safety, Biomarker, Clinical Pharmacology & Therapeutics, Peptide, Classification, Hypertension, Metabolic syndrome, Acute coronary syndrome, Insulin resistance, Fatty liver disease, CYP2E1, Lithium, Body mass index, Reproduction, EMA, IBW, Injection, Anker, NCA, Enzyme, Inflammation, Cancer, Weight loss, Gastrointestinal tract, Cardiac output, Public health, Adipokine, CYP2C9, E pluribus unum, Physiology, Agency, Risk, Steroid, Lymph, CYP2D6, BSA, GI, Cytokine, Systematic review, Vaccine

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

Veradigm and American College of Cardiology Launch Influenza Vaccination Education Initiative to Improve Cardiovascular Health

Retrieved on: 
Mardi, février 13, 2024
Health Technology, White House, Federal Government, Data Management, Other Education, Technology, Practice Management, Pharmaceutical, Education, Professional Services, Infectious Diseases, Public Policy, Government, Cardiology, Biotechnology, Software, Data Analytics, Health, Senior, MD, Physician, American College of Cardiology, Cardiovascular disease, ACS, Practice management, EHR, Stroke, MBA, SCM, MDRX, Risk, HHS, Heart failure, Vaccination, Unitary state, CMSS, American College, Council, Acute coronary syndrome, Patient, Practice Fusion, CDC, ACC, Inc., VAX, Medical specialty, Evidence-based practice, Workflow, Pharmaceutical industry

Veradigm Inc. (NASDAQ: MDRX), a leading provider of healthcare data and technology solutions announced today the launch of TRANSFORM VAX, an American College of Cardiology (ACC)-sponsored initiative aimed at improving cardiovascular health through increased influenza vaccination education.

Key Points: 
  • Veradigm Inc. (NASDAQ: MDRX), a leading provider of healthcare data and technology solutions announced today the launch of TRANSFORM VAX, an American College of Cardiology (ACC)-sponsored initiative aimed at improving cardiovascular health through increased influenza vaccination education.
  • Influenza vaccination is associated with a lower risk for adverse cardiovascular events, with an overall 34% lower risk of major adverse cardiovascular events and a 45% lower risk among individuals with recent acute coronary syndrome (ACS).1 As part of this quality improvement initiative, Veradigm is delivering ACC-sponsored vaccination education messaging to a subset of cardiology practices using the Practice Fusion EHR (a Veradigm Network solution).
  • The messages appear as banner advertisements in an in-frame window adjacent to the EHR workflow that is separate and distinguishable from the clinical and practice management workflow within the EHR.
  • “Veradigm is proud to be working with the ACC to apply our real-world data in combination with our messaging capabilities to improve rates of recommended vaccinations for adults with cardiovascular disease,” said Stuart Green, Senior Vice President and General Manager at Veradigm.

Imperial College London TELE-ACS Clinical Trial Results, Using SHL Telemedicine’s SmartHeart® Technology, to Be Presented at ACC 24

Retrieved on: 
Jeudi, février 1, 2024
Cardiology, Biotechnology, Technology, Managed Care, Other Health, Health, Health Technology, Medical Devices, Internet, Telemedicine, Virtual Medicine, Clinical Trials, Telehealth, American College, Clinical trial, Patient, Imperial College London, SHL, ECG, Acute coronary syndrome, ACC, Pharmaceutical industry

The TELE-ACS trial is a pivotal study that marks a significant milestone in telemedicine and cardiovascular care.

Key Points: 
  • The TELE-ACS trial is a pivotal study that marks a significant milestone in telemedicine and cardiovascular care.
  • Erez Nachtomy, CEO of SHL Telemedicine, commented: “We would like to congratulate the team at Imperial College London on the acceptance of the TELE-ACS trial results for presentation at ACC 24.
  • This achievement is a testament to the researchers and their rigorous effort to conduct this groundbreaking work.
  • We very much look forward to seeing the presentation at ACC 24 which will share the embargoed full trial results with the global cardiology community.”
    ACC 24 Participants are invited to add the session to their itinerary using the following link: https://www.abstractsonline.com/pp8/#!/10973/presentation/22832

Global Atherectomy Devices Market Report 2023-2030: Industry Trends, Growth, Share, Outlook, Impact of Inflation, Opportunities, Company Analysis - ResearchAndMarkets.com

Retrieved on: 
Lundi, janvier 8, 2024
Health, Medical Devices, Cardiology, Artery, Heart, Statistics, Neurovascular bundle, Cardinal Health, Circulatory system, Atherectomy, World Health Organization, Stroke, Prevalence, Atherosclerosis, Abbott Laboratories, Physician, CAD, Blood, Myocardial infarction, Patient, Australian Bureau of Statistics, Acute coronary syndrome, Incidence, Element, Plaque, World Games, Application, PAD, Pharmaceutical industry

The "Atherectomy Devices Market, Size, Global Forecast 2023-2030, Industry Trends, Growth, Share, Outlook, Impact of Inflation, Opportunity Company Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Atherectomy Devices Market, Size, Global Forecast 2023-2030, Industry Trends, Growth, Share, Outlook, Impact of Inflation, Opportunity Company Analysis" report has been added to ResearchAndMarkets.com's offering.
  • Atherectomy devices are minimally invasive medical devices that are used to eliminate plaque build-up from the partitions of arteries.
  • By Product Type, Global Atherectomy Devices Market is divided into Directional Atherectomy, Rotational Atherectomy, Orbital Atherectomy and Laser Atherectomy.
  • Hospitals are poised to maintain their stronghold with the very best market proportion in the Atherectomy Devices Market.

Jiangsu Vcare Files NDA for Vicagrel Capsules with US FDA

Retrieved on: 
Jeudi, janvier 4, 2024
Clopidogrel, Coagulation, FDA, Acute coronary syndrome, Stroke, Moyamoya disease, Patient, Food, NDA, Pharmaceutical industry

This filing marks a significant milestone as Jiangsu Vcare's first NDA submission from its innovative drug pipeline.

Key Points: 
  • This filing marks a significant milestone as Jiangsu Vcare's first NDA submission from its innovative drug pipeline.
  • This NDA filing builds on continuous dialogues with the FDA and is supported by robust nonclinical data and clinical studies conducted in both China and US.
  • Vicagrel, a novel oral P2Y12 receptor antagonist, represents Jiangsu Vcare's commitment to addressing unmet clinical needs with innovative approaches.
  • This NDA filing reflects more than ten years of persistent innovation and dedication by Jiangsu Vcare.

Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel, Date of authorisation: 23/09/2009, Revision: 19, Status: Authorised

Retrieved on: 
Mardi, janvier 2, 2024
Patient, Medical Subject Headings, Marketing, Acute coronary syndrome, Artery, European Commission, Agency, Moyamoya disease, INN, Risk, Platelet, ATC, Myocardial infarction, Bleeding, International, European, Blood, Language, Brain, Heart, Splenic infarction, Vascular disease, European Medicines Agency, Tablet, ADP, Select, Chest pain, Aspirin, Anatomy, Medicine, IIA, Atrial fibrillation, Medical device

Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel, Date of authorisation: 23/09/2009, Revision: 19, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel, Date of authorisation: 23/09/2009, Revision: 19, Status: Authorised