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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.
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.
Amit Goyal of the Cleveland Clinic will present “The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment With Trainee Development.” Goyal is a fellow in interventional/structural cardiology at the Cleveland Clinic and a cofounder of CardioNerds, an initiative to democratize cardiovascular education.
Clinical Trial, Medical Education. The goal of the CardioNerds Clinical Trials Network is to pair equitable enrollment with trainee development. Like many trials during the COVID-19 pandemic, there were significant challenges and recruitment delays. What did this activity displace in a busy cardiology fellow’s day?
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.,
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.
… 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 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.
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.
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.
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
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.
“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.
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
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.,
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.
Bringing our visions for clinical research to life in local communities with little knowledge of the role and benefits of clinical trials initially proved more difficult than we expected,” says Kristen Gurnea, MPH, CCRC, ACRP-PM, Manager of Clinical Research, Renown Health. “We
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.
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.
Researchers from Belgium, the Netherlands, Russia, and Italy have developed a breakthrough method for quickly, accurately, and reliably diagnosing cardiac arrhythmias. This is a unique method to diagnose pathogenic areas in the heart in a minute Credit: Front. They called it Directed graph mapping (DGM).
As a consequence, people with the condition can develop cardiovascular disease very early, even in childhood in some cases, despite aggressive treatment with cholesterol-lowering drugs like statins and PCSK9 inhibitors.
The five new NHS 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.
Last year, BMS and J&J reported the first proof-of-concept data for milvexian in the AXIOMATIC-TKR trial, showing that the drug was able to prevent venous thromboembolism (VTE) in people undergoing total knee replacement surgery without raising the risk of bleeding events.
The Toronto-based company has recently announced positive results from an independent clinical trial which showed that their fluorescence imaging device MolecuLight i :X improved 12-week wound healing of diabetic foot ulcers by 204 percent. Orthopaedics have X-ray, cardiology has echocardiography, cancer has ultrasound, PET, CT and MRI.
Three ongoing influenza vaccine cardiovascular outcomes trials could hold insights into testing novel interventions against COVID-19 Seasonal influenza vaccine development and mass production, as well as three international influenza vaccine cardiovascular outcomes trials currently underway, may inform future efforts targeted at developing and evaluating (..)
XTALKS WEBINAR: Environmental Sustainability and the Supply of Medicines for Clinical Trials 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.
In the trial, the safety profile of Ultomiris was comparable to placebo and consistent with that observed in Phase III trials of Ultomiris in paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). The trial enrolled 175 patients across North America, Europe, Asia-Pacific and Japan.
The acquisition of KO-MED is Velocity’s first foray into Oncology research, which accounts for roughly 40-50% of clinical trials globally. In most cases, the participant of a clinical trial benefits from taking part, which is of great importance, especially in oncological trials. and Europe.
Felker and Dr. Udelson join current advisors to support the development ofalfapump ® DSR for the management of fluid overload in patients with heart failure. The Sequana Medical management team is working closely with its advisors on the development of alfa pump DSR (Direct Sodium Removal). GHENT, Belgium, Oct.
. – 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 […].
This development could significantly impact CAD management, particularly for patients suffering from ISR, a condition characterized by the re-narrowing of arteries previously treated with stents. Many companies have already developed their own DCBs, each with unique features supported by varying levels of clinical evidence.
Introduction to Electronic Case Report Forms (eCRF) In the ever-evolving landscape of clinical trials, 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.
Pharma brands can develop: Whitepapers on clinical trials showcasing drug effectiveness. Scientific blogs discussing new advancements in oncology, cardiology, or rare diseases. Behind-the-scenes research lab videos showcasing drug development. Case studies on patient outcomes using specific treatments.
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