Troponin

Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Date of authorisation: 18/05/2020, Revision: 14, Status: Authorised

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Tuesday, January 2, 2024
Patient, Liver, Medical Subject Headings, Marketing, Survival, INN, Risk, Fever, Caregiver, Spinal muscular atrophy, ATC, SMN2, Platelet, International, Disease, Atrophy, Language, Troponin, SMN1, Thrombocytopenia, Ventilation, European Medicines Agency, Select, Hepatotoxicity, Facial muscles, Safety, Anatomy, Vomiting, IIA, SMA, Medical device

Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Date of authorisation: 18/05/2020, Revision: 14, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Date of authorisation: 18/05/2020, Revision: 14, Status: Authorised

Global Cardiac Marker Testing Market Expected to Reach $6.9 Billion by 2028, Driven by Aging Population and Rising Cardiovascular Diseases - ResearchAndMarkets.com

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Thursday, November 9, 2023
Research, Medical Devices, Medical Supplies, Seniors, Cardiology, Biotechnology, Consumer, Health, Science, Other Science, BNP, Prevalence, Troponin I, Clinical Laboratory Improvement Amendments, ASP, Cardiovascular disease, CK-MB, USD, Point-of-care testing, Membrane protein, Compound annual growth rate, Diagnosis, Growth, Reagent, CHF, Government agency, Troponin, ELISA, Medical device, Atherosclerosis, Disease, Myoglobin, Chemiluminescence

The global cardiac marker testing market is poised for substantial growth, with projections estimating it to reach USD 6.9 billion by 2028, a significant increase from its 2022 value of USD 4.1 billion.

Key Points: 
  • The global cardiac marker testing market is poised for substantial growth, with projections estimating it to reach USD 6.9 billion by 2028, a significant increase from its 2022 value of USD 4.1 billion.
  • Aging Population: The increasing global aging population has led to a higher prevalence of cardiovascular diseases.
  • Rising Cardiovascular Diseases: Cardiovascular diseases are on the rise worldwide, making cardiac marker testing an essential tool for the diagnosis and monitoring of these conditions.
  • In 2022, laboratory testing facilities represented the largest share, accounting for 61.2% of the global cardiac marker testing market.

Attralus Announces Publication of Two Studies Evaluating Iodine (124I) Evuzamitide (AT-01) using PET/CT in the Journal of American College of Cardiology (JACC CV Imaging)

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Tuesday, November 7, 2023
MCF, Quality of life (healthcare), HIV disease progression rates, CMP, ID, Amyloid cardiomyopathy, Echocardiography, MRI, MPH, Health, Troponin, Cardiology, Cardiac amyloidosis, GLS, Journal, BWH, University, Patient, N-terminal prohormone of brain natriuretic peptide, Amyloidosis, Heart, LV, Publication, JACC, PET, Quality of life, TBR, Editorial, PET/CT, CAA, Amyloid, Harvard Medical School, ATTR, Devouring Radiant Light, Literature, Alys, Diagnosis, ECV, SAN, Medical imaging, Hospital, AL amyloidosis, Medicine, Iodine, Brigham

124I-evuzamitide may be more sensitive than standard diagnostics, with cardiac uptake shown in ATTR patients who had negative 99mTc-PYP scans.

Key Points: 
  • 124I-evuzamitide may be more sensitive than standard diagnostics, with cardiac uptake shown in ATTR patients who had negative 99mTc-PYP scans.
  • The manuscripts from Brigham and Women’s Hospital (BWH) and from the University of Tennessee Graduate School of Medicine were published in the Journal of American College of Cardiology – Cardiovascular Imaging (JACC CV Imaging).
  • The manuscripts, entitled “Cardiac Amyloid Quantification Using 124I-Evuzamitide (124I-P5+14) Versus 18F-Florbetapir” and “Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14): A Phase 1/2 Study,” have been published online.
  • These studies suggest that 124I-evuzamitide is a promising novel radiotracer to detect and quantify cardiac amyloid in multiple types of amyloidosis.

Integration of Multiple Biomarkers Fuels Robust 12.14% CAGR in Global Cardiac Biomarkers Market Through 2028 - ResearchAndMarkets.com

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Monday, November 6, 2023
Health, Cardiology, Viral Research and Diagnostic Laboratories, Heart failure, Health care, Biomarker, Acute coronary syndrome, Prevalence, Cardiovascular disease, Creatine kinase, Splenic infarction, Research, R, CVD, Growth, Hospital, Risk assessment, ACS, Troponin, Myoglobin, Diagnosis, Medical imaging, Medical device

The global cardiac biomarkers market is projected to experience robust growth, reaching $26.43 billion by 2028, with a compound annual growth rate (CAGR) of 12.14% from 2022 to 2028.

Key Points: 
  • The global cardiac biomarkers market is projected to experience robust growth, reaching $26.43 billion by 2028, with a compound annual growth rate (CAGR) of 12.14% from 2022 to 2028.
  • Key Market Trends & Drivers:
    Integration of Multiple Cardiac Biomarkers: Healthcare professionals are increasingly combining information from various cardiac biomarkers to gain a comprehensive understanding of a patient's cardiac health.
  • Increasing R&D Activities: The market is witnessing a surge in research and development (R&D) activities focused on novel cardiac biomarkers.
  • The global cardiac biomarkers market is highly competitive, with players ranging from pharmaceutical companies and diagnostic manufacturers to biotechnology firms and research institutions.

Cardiac Biomarkers Market is Set to Reach $26.43 Billion by 2028, Fueled by Widespread Multi-Biomarker Adoption - Arizton

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Tuesday, October 17, 2023
Incidence, Hospital, Benefit, Disease, Biomarker, Send, Research, Government, Prevalence, Risk, Myoglobin, Mortality, Health, Facial muscles, CVD, Troponin, Ageing, Protein, Creatine kinase, Troponin I, Blood, Prognosis, Patient, Medical device

the global market for cardiac biomarkers can be categorized based on biomarker types, which include troponin, creatine kinase (CK-MB), myoglobin, and other biomarkers.

Key Points: 
  • the global market for cardiac biomarkers can be categorized based on biomarker types, which include troponin, creatine kinase (CK-MB), myoglobin, and other biomarkers.
  • The global market for cardiac biomarkers can be divided by end-user into hospitals, diagnostic laboratories, and other healthcare facilities.
  • Europe holds a significant share of the global cardiac biomarkers market due to the rising incidence of CVDs and an aging population.
  • In addition, government initiatives to improve healthcare facilities and reduce CVD-related morbidity and mortality further boost the adoption of cardiac biomarkers in Europe.

Cardiac Biomarkers Market is Set to Reach $26.43 Billion by 2028, Fueled by Widespread Multi-Biomarker Adoption - Arizton

Retrieved on: 
Tuesday, October 17, 2023
Incidence, Hospital, Benefit, Disease, Biomarker, Send, Research, Government, Prevalence, Risk, Myoglobin, Mortality, Health, Facial muscles, CVD, Troponin, Ageing, Protein, Creatine kinase, Troponin I, Blood, Prognosis, Patient, Medical device

the global market for cardiac biomarkers can be categorized based on biomarker types, which include troponin, creatine kinase (CK-MB), myoglobin, and other biomarkers.

Key Points: 
  • the global market for cardiac biomarkers can be categorized based on biomarker types, which include troponin, creatine kinase (CK-MB), myoglobin, and other biomarkers.
  • The global market for cardiac biomarkers can be divided by end-user into hospitals, diagnostic laboratories, and other healthcare facilities.
  • Europe holds a significant share of the global cardiac biomarkers market due to the rising incidence of CVDs and an aging population.
  • In addition, government initiatives to improve healthcare facilities and reduce CVD-related morbidity and mortality further boost the adoption of cardiac biomarkers in Europe.

Rocket Pharmaceuticals Reaches FDA Alignment on Pivotal Phase 2 Trial Design for RP-A501 in Danon Disease

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Tuesday, September 12, 2023
Research, FDA, Genetics, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Science, NYHA, Male, CMS, LV, Troponin, IMPD, CMC, Center for Biologics Evaluation and Research, CTA, KCCQ, Disorder, Natriuresis, Medication, New York Heart Association Functional Classification, Food and Drug Administration Amendments Act of 2007, Clinical trial, CGMP, Patient, Heart transplantation, Immunohistochemistry, Mortality, Danon disease, Death, Food, Safety, Disease, Pharmaceutical industry, Medical device, EU, LAMP2

The disease affects an estimated 15,000 to 30,000 patients in the U.S. and Europe.

Key Points: 
  • The disease affects an estimated 15,000 to 30,000 patients in the U.S. and Europe.
  • A global natural history study will serve as an external comparator and run concurrently to the Phase 2 pivotal trial.
  • In-house manufacturing has been completed with sufficient high-quality drug product produced to fully supply the Phase 2 pivotal study.
  • Additionally, Rocket has secured an ICD-10 code from CMS for LAMP2 deficiency in Danon Disease

LumiraDx Announces Strategic Refocus and Cost Restructuring Program

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Thursday, April 6, 2023
Workforce, Troponin, Platform, Cost, Growth, Pharmaceutical industry, Management

LONDON, April 06, 2023 (GLOBE NEWSWIRE) -- LumiraDx Limited (Nasdaq: LMDX), a leading global provider of point-of-care diagnostics testing solutions, today announced its Strategic Refocus and Cost Restructuring Program aimed at reducing its scale and operations to pre-pandemic levels and to further evolve LumiraDx into an agile organization with a clear focus on the areas with the greatest potential.

Key Points: 
  • LONDON, April 06, 2023 (GLOBE NEWSWIRE) -- LumiraDx Limited (Nasdaq: LMDX), a leading global provider of point-of-care diagnostics testing solutions, today announced its Strategic Refocus and Cost Restructuring Program aimed at reducing its scale and operations to pre-pandemic levels and to further evolve LumiraDx into an agile organization with a clear focus on the areas with the greatest potential.
  • The program is part of LumiraDx’s ongoing efforts to streamline strategic focus and operations, optimize its cost structure and position itself for sustainable growth in the post-pandemic world.
  • Under the Cost Restructuring Program, LumiraDx will further reduce its global workforce by approximately 40%, including full-time, part-time and contractor positions.
  • In addition to the headcount reductions, LumiraDx will continue the implementation of operating cost reductions.

Rocket Pharmaceuticals Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for RP-A501 Gene Therapy for Danon Disease

Retrieved on: 
Tuesday, February 7, 2023
Health, FDA, Genetics, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, AAV, NYHA, Troponin, Danon disease, Natural history, Biologics license application, Disorder, Drug development, LAMP2, Breakthrough therapy, Patient, Clinical trial, News, Food, BNP, RP, New York Heart Association Functional Classification, Disease, 21st Century Cures Act, Orphan drug, Adolescence, Risk assessment, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, LV, Medication, Pharmaceutical industry, Medical device

“Today’s exciting RMAT designation demonstrates recognition from the FDA of the early meaningful benefit of RP-A501 in Danon Disease and its potential to deliver lifesaving treatment for patients,” said Gaurav Shah, M.D., Chief Executive Officer, Rocket Pharma.

Key Points: 
  • “Today’s exciting RMAT designation demonstrates recognition from the FDA of the early meaningful benefit of RP-A501 in Danon Disease and its potential to deliver lifesaving treatment for patients,” said Gaurav Shah, M.D., Chief Executive Officer, Rocket Pharma.
  • As previously disclosed, the Company anticipates pursuing a single arm, open-label trial with a biomarker-based composite endpoint and a natural history comparator.
  • Results from the Phase 1 program represent one of the most comprehensive investigational gene therapy datasets for any cardiac condition.
  • Overall, the results demonstrate improvements and/or normalization across multiple quantifiable parameters that cardiologists use in clinical practice to enable risk assessment and treatment decisions.

Global Cardiac Troponin (Troponin I and Troponin T) Diagnostics Market Forecasts and Opportunities to 2025 with Abbot, Roche, and Siemens Healthineers Dominating as New Players Enter the Market - ResearchAndMarkets.com

Retrieved on: 
Friday, December 23, 2022
Medical Devices, Health, Troponin, Myocardial infarction, Troponin I, Research, Biomarker, Laboratory, MI, Siemens Healthineers, Hospital, POCT, Patient, EDS, Physician, Point-of-care testing, Diagnosis, Medical device, CTN

The "Cardiac Troponin Diagnostics - Forecasts and Opportunities to 2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cardiac Troponin Diagnostics - Forecasts and Opportunities to 2025" report has been added to ResearchAndMarkets.com's offering.
  • Cardiac troponin (cTn) biomarkers are the gold standard in myocardial infarction (MI) diagnosis, leading healthcare professionals to use cTn diagnostics.
  • In addition, companies such as QuidelOrtho and Siemens Healthineers have developed high-sensitivity POCT cTn assays that provide accurate results within a few minutes.
  • The analyst's research shows high consolidation in the cTn diagnostics market, with players such as Abbot, Roche, and Siemens Healthineers dominating.