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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 clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
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?
Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. The 400 mg dose was the highest lepodisiran dose in the trial.
The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial 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.”
Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. There are several strategies that will help increase diversity in CVD trials. Increasing diversity in trial leadership is one of the most important strategies to increase diversity among RCT participants.
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 cardiology clinics across the U.S.,
The trial demonstrated a 42 percent reduction in combined cardiovascular death and recurrent hospitalizations at Month 30, with cardiovascular-related hospitalizations reduced by half. Participants were randomized to receive acoramidis or placebo over 30 months.
This includes new Phase III trial data for Kerendia (finerenone) in patients with heart failure that was presented recently at this year’s European Society of Cardiology (ESC) Congress 2024. Dr. Perkins has also led the development and implementation of innovative digital educational outreach campaigns for primary care physicians.
billion Company/developer :Bristol Myers Squibb (BMS), Pfizer Date of first FDA approval :December 28, 2012 FDA-approved indications :Stroke prevention in atrial fibrillation; venous thromboembolism (VTE) prevention; orthopedic surgery; VTE treatment Price of Eliquis :The list price for a 30-day supply of Eliquis is $594.
… 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.,
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) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.
Late-stage clinical trial 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. Heart failure affects about 6.2
Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinical trials. Vice President of the Medical Department and Cardiology therapeutic lead, and Heather Lohr, Sr. Director of Clinical Trial 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.
The context and stakeholder input have been key in developing and implementing nudges. The PRESCRIBE trial revealed the value of active choice as well as peer decision-making to prompt decision-making. There is opportunity for more evidence to be developed and to implement lessons that have been learned.
Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. Working out which are more likely to benefit from stem cell therapy is likely to be a key challenge for developers. An interim look at the results is due later this month.
The FDA’s Total Product Lifecycle Advisory Program supported the streamlined development and clearance of the EchoGo Amyloidosis device. One such study, the PREVAMIC trial conducted in Spain , found that cardiac amyloidosis was present in 20.1 Cardiac amyloidosis can significantly shorten survival times if not diagnosed early.
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.
Hope that AstraZeneca’s diabetes and heart failure drug Farxiga might treat patients hospitalised with COVID-19 have been dashed after the drug failed to make an impact in a phase 3 trial. . On the plus side, there were no safety issues in the trial.
Alexion is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS). The IDMC recommended that the trial be discontinued due to lack of efficacy. Data from the trial will be provided to inform ongoing research. CHAMPION-ALS.
The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects. The webinar will also cover: What the NPRCs’ franchise model means for research delivery.
The summit focused on Velocity’s Diabetes + Obesity, MASH, Vaccine, Cardiology, and Women’s Health CARE Councils, along with a few areas in development.
Cardiovascular clinical trials 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 clinical trials. The Diversity of the US Population.
Positive high-level results from the FoCus Phase III trial in Wilson disease showed ALXN1840 met the primary endpoint with a statistically significant improvement in daily mean copper mobilisation from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments. 1 It affects one in 30,000 live births in the US.
Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.
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 clinical trial is to evaluate the safety, tolerability, and?preliminary?efficacy?of Senior Vice President, Clinical Development, BlueRock Therapeutics. “We
Results from the Phase III EMPEROR-Preserved trial were presented today at the European Society of Cardiology Congress 2021 2 and published in The New England Journal of Medicine 1. 1 Trial participants were randomly assigned to empagliflozin 10 mg (n=2,997) or placebo (n=2,991) once daily.
UK-based RHYTHM AI is to go ahead with a larger clinical trial of its artificial intelligence (AI)-driven system, which could be used as a treatment for atrial fibrillation without the need for medication. Clinical development of the system got off the ground last year when the company announced the closure of a £2.15m financing round.
Shares in Amgen were down nearly 7% after close of trading yesterday after the company’s heart failure drug omecamtiv mecarbil disappointed in a large phase 3 trial. Amgen looks in need of fresh home-grown revenues, but investors don’t think these will come from omecamtiv mecarbil, based on the findings of the phase 3 GALACTIC-HF trial.
Heerspink, Professor of Clinical Trials 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. In July, finerenone was approved under the name Kerendia® by the us (U.S.)
“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 clinical trial research work in heart health, noting most new drugs never make it to market.
Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health. . Audentes Therapeutics’ ASPIRO Trial Free to Proceed. Billion Myovant/ Pfizer Deal. mg) in the US and Canada.
a Canadian biopharmaceutical firm specializing in cardiovascular therapies, recently reported positive results from a Phase III clinical trial of its leading candidate, etripamil nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone Pharmaceuticals Inc., How Does Etripamil Nasal Spray Work?
This early-stage trial is set to enroll ten patients across the US and Canada, with its primary aim to evaluate the safety and tolerability of DA01 cell transplantation at one year post-transplant. BlueRock Therapeutics secures FDA fast track for Parkinson’s disease cell therapy.
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, […].
New data, including two late-breaking clinical trial 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
Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial 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.
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. About Velocity Clinical Research Velocity is the leading integrated site organization for clinical trials. and Europe.
The approval is based on the results of the pivotal Phase III VICTORIA trial, published in The New England Journal of Medicine (NEJM) in March 2020. Bayer is proud of the approval of vericiguat in Japan and the contribution it has shown in clinical trials.”. Vericiguat is being jointly developed with MSD (a tradename of Merck & Co.,
Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and top investigator of the FIDELIO-DKD trial. “ The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinical development.
Not long ago, the companies inked an oncology pact to develop and commercialize MorphoSys’ anti-CD19 antibody Monjuvi jointly. Siemens Healthineers, formed as a result of spin-off in 2018, plans to increase its presence in oncology, neurology as well as cardiology domain. Billion deal in a thirst to grow in the cancer market.
Novo Nordisk has announced plans to move its ziltivekimab into phase 3 clinical development 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.
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.
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. The primary endpoint of the trial is patient survival at 180 days post-implant, or a successful cardiac transplantation.
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