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Yet enrollment of ethnic minorities in NIH clinicaltrials and for trials studying approved devices and drugs remains low. Further efforts are urgently needed to increase diversity in the cardiology workforce, which will improve clinicaltrial diversity and cardiovascular health for all.
The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinicaltrial conducted in 5,522 chronic coronary disease patients. We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.”
Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential?
Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinicaltrials. In CV clinicaltrials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinicaltrials. Vice President of the Medical Department and Cardiology therapeutic lead, and Heather Lohr, Sr. Director of ClinicalTrial Management.
DCP developed an EHR-based workflows and integrated workflows within the local VA primary care setting. DCP developed 3 electronic workflows with 6 major configurations including applications needed outside of the EHR system. DCP developed a patient tracking tool that nurses could use to make sure patients got through each step.
Cardiovascular clinicaltrials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinicaltrials. The Diversity of the US Population.
Late-stage clinicaltrial failures are largely to blame for the lack of effective treatment options for patients with HFpEF, and poor five-year survival rates make this an area of great unmet need. The reverse could also be true whereby the development of coronary artery disease may impact heart rate. HFrEF vs. HFpEF.
… Pfizer told employees it plans to pull back on early-stage research into treatments for rare diseases, including the development of new viral-based gene therapies , Barron’s reports. Among the assets on the chopping block is a gene therapy manufacturing facility in Durham, N.C.,
The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies. This was a cluster-randomized trial of 42 cardiologyclinics across the U.S.,
Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinicaltrial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.
The summit focused on Velocity’s Diabetes + Obesity, MASH, Vaccine, Cardiology, and Women’s Health CARE Councils, along with a few areas in development.
The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinicaltrials in the UK by offering new ways to conduct late-phase, large-scale research projects.
The context and stakeholder input have been key in developing and implementing nudges. Discussion Themes – In the last few years, there has been great reception to the value of behavioral science and implementation science in the field of cardiology.
But Dr Craig Granowitz, chief scientific officer of cardiology drug developer Amarin, says that this is only the tip of the iceberg when it comes to the devastating impact of CVD on global populations. “In Granowitz says that the most sobering statistic from the REDUCE-IT study actually comes from the control group. Think about that.
Heerspink, Professor of ClinicalTrials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee.
Empagliflozin, a recently developed diabetes drug, can effectively treat and reverse heart failure in both diabetic and non-diabetic patients, according to researchers at the Icahn School of Medicine at Mount Sinai.
The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinicaldevelopment. Bayer is committed to drive sustainable development and induce a positive impact with its businesses.
a Canadian biopharmaceutical firm specializing in cardiovascular therapies, recently reported positive results from a Phase III clinicaltrial of its leading candidate, etripamil nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone Pharmaceuticals Inc., How Does Etripamil Nasal Spray Work?
New data, including two late-breaking clinicaltrial presentations on mavacamten and a new analysis of the GUARD-AF study, reinforce the company’s continued commitment to those living with cardiovascular disease. senior vice president, head of cardiovascular development and global drug development at Bristol Myers Squibb. “We
“Without clinical research, there would be little if any development of new medicines,” says Isabelle Schenkenberger, MD. I’m proud and excited to be a part of it.” Dr. Schenkenberger is especially proud of her clinicaltrial research work in heart health, noting most new drugs never make it to market.
In addition to being one of Poland’s top recruiting sites in cardiologytrials, ClinMedica also recruits patients across a broad range of therapeutic areas involving ambulatory medicine. As a result, Sponsors and CROs can benefit from simplified access to international clinical research capabilities. and Europe.
This expanded clinical research opportunities for patients as a core pillar of the affiliation’s mission, with the goal of providing access to novel treatments for diagnoses in addition to standard of care. An important step was a review of the state of clinicaltrial awareness at the time of the affiliation agreement.
Tools for clinicians in point-of-care use UTICA, NY — More than 2 million coronary artery stents are implanted each year to help protect or restore normal blood flow to the heart, to treat patients suffering from angina or a heart attack due to coronary artery disease (CAD). While stents are highly effective and safe devices, […].
COVID-19 pneumonia spreads like multiple wildfires, leaving destroyed lung tissue in its wake ‘This effort truly represents a “moonshot” in COVID-19 research’ Scientists identify target to treat COVID pneumonia and reduce severity Clinicaltrials with new experimental drug to begin early in 2021 Goal is to develop treatments (..)
XTALKS WEBINAR: Environmental Sustainability and the Supply of Medicines for ClinicalTrials Live and On-Demand: Thursday, January 16, 2025, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn how major pharma companies are working towards environmental sustainability and reducing their environmental impact.
At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients.
The five new NHS Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinicaltrials in the UK by offering new ways to conduct late-phase, large-scale research projects.
This is the finding of a study by investigators at the Centro Nacional de Investigaciones Cardiovasculares (CNIC), published today in the Journal of the American College of Cardiology (JACC). The most severe form of COVID-19 is severe respiratory failure, which requires intubation and is associated with a high mortality rate.
The acquisition of KO-MED is Velocity’s first foray into Oncology research, which accounts for roughly 40-50% of clinicaltrials globally. KO-MED has been the leading multi-site network in Poland since 2020, having enrolled over 9,000 patients into clinical research. and Europe.
Researchers from Belgium, the Netherlands, Russia, and Italy have developed a breakthrough method for quickly, accurately, and reliably diagnosing cardiac arrhythmias. The technology principles are published in JACC: Clinical […]. This is a unique method to diagnose pathogenic areas in the heart in a minute Credit: Front.
A unique commission that today issued major new recommendations aimed at fully understanding and reducing the global burden of heart disease in women was led by Roxana Mehran, MD, Professor of Medicine, and Population Health Science and Policy, and Director of Interventional Cardiovascular Research and ClinicalTrials at the Icahn School of Medicine (..)
UK-based RHYTHM AI is to go ahead with a larger clinicaltrial of its artificial intelligence (AI)-driven system, which could be used as a treatment for atrial fibrillation without the need for medication. Clinicaldevelopment of the system got off the ground last year when the company announced the closure of a £2.15m financing round.
An experimental artificial heart developed by French medical device specialist CARMAT has been implanted into the first of 10 subjects due to be enrolled in a US trial. It is also rolling out the artificial heart in France within the framework of a 52-patient clinicaltrial.
Novo Nordisk has announced plans to move its ziltivekimab into phase 3 clinicaldevelopment in atherosclerosis with chronic kidney disease after a mid-stage trial met its main goal. Data were announced at the virtual American College of Cardiology annual conference and published simultaneously in The Lancet.
In order to do so, the DSMC may review unblinded study information (on a patient level or treatment group level) during the conduct of the trial.
The CEC comprises clinical experts in cardiology and Intensive Care and has been established to ensure accurate and consistent assessment of the trial endpoints and/or serious adverse events.
Alexion is discontinuing CHAMPION-ALS, the global Phase III clinicaltrial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS). The IDMC recommended that the trial be discontinued due to lack of efficacy.
the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD). Ph1 clinicaltrial is to evaluate the safety, tolerability, and?preliminary?efficacy?of Senior Vice President, ClinicalDevelopment, BlueRock Therapeutics.
It represents a major milestone in our efforts to develop next-generation products to help millions of people affected by peripheral artery disease and the physicians that treat them.” SurVeil’s FDA approval was based on 24 months of data from the pivotal, head-to-head TRANSCEND clinicaltrial that compared it against Medtronic’s IN.PACT.
. – A medical-device startup that aims to improve the health of pregnant women is the top winner in an annual pitch contest presented by the Massachusetts Medical Device Development Center (M2D2). Now in its ninth year, the M2D2 $200K Challenge showcases the inventions […].
Introduction to Electronic Case Report Forms (eCRF) In the ever-evolving landscape of clinicaltrials, the transition from traditional paper-based case report forms to electronic Case Report Forms (eCRFs) has marked a significant advancement in how clinical data is collected, managed, and analyzed.
Caelum”) is a clinical-stage biotechnology company developing treatments for rare and life-threatening diseases. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines.
And you won’t be spared simply by keeping high blood pressure at bay until you hit your golden years, because the study found that even those who hadn’t developed high blood pressure until becoming seniors still experienced a faster decline in thinking skills than those who continued to remain heart-healthy in their golden years.
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