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Its becoming more expensive and time-consuming to move a drug from the clinicaltrial stage to approval. Patient recruitment is the leading driver of costs in clinicaltrials, and 55% of trials that fail to complete cite low accrual rate as the reason for study termination.
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?
Yet enrollment of ethnic minorities in NIH clinicaltrials and for trials studying approved devices and drugs remains low. Increasing diversity in trial leadership is one of the most important strategies to increase diversity among RCT participants. We have to change how we are practicing.
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.
XTALKS WEBINAR: Keys to Success in ClinicalTrials: A Strategic Guide for Biotechs and Startups Live and On-Demand: Thursday, May 22, 2025 , at 11am EDT (5pm CEST / EU-Central) Register for this free webinar to learn how biotechs can navigate endpoint challenges in clinicaltrials.
The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The drugs were administered open label and all patients were given a low dose of aspirin.
The FDA has set a prescription drug user fee act (PDUFA) target action date of December 12, 2025, and currently does not plan to hold an advisory committee meeting regarding the application. Over 2,400 patients have continued in the 72-week open-label extension trial.
Minority ethnicities and regions derive at least as much cardiovascular benefit from lipid-lowering therapies as majority groups despite being underrepresented in clinicaltrials, according to a study published today in the European Journal of Preventive Cardiology.
Abbott Laboratories announced on Monday that the US Food and Drug Administration (FDA) approved its Aveir™ single-chamber (VR) leadless pacemaker system. XTALKS WEBINAR: Cardiac Safety Solutions in Decentralized ClinicalTrials (DCT). Live and On-Demand: Tuesday, May 24, 2022, at 1pm EDT (10am PDT).
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.
Ionis Pharmaceuticals recently announced that its drug, Tryngolza (olezarsen), has been approved as an adjunct to diet for the reduction of triglyceride levels in FCS patients, who have long faced a condition with no existing pharmacological solutions. In the Balance study, patients who received the drug showed a 42.5
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). One such drug is Adenosine, which was initially approved by the FDA in 1989.
Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinicaltrials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe.
Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial when administered to COVID-19patients. 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).
“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. The site has 2 full-time investigators and cooperates closely with specialists for internal medicine, orthopedics, neurology, and cardiology.
The licensing deal took place as AZ was trimming down its pipeline to focus its R&D activities on the core areas of cardiology, diabetes and neurology, and recovering from a series of patent expiries that hit its revenues. Since then it has bounced back dramatically, thanks to fast-growing drugs for cancer and heart disease.
Randomized clinicaltrial finds no mortality risk or benefit associated with drug-coated devices in the treatment of peripheral artery disease NEW YORK – October 18, 2020 – A large subgroup analysis of a randomized clinicaltrial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) (..)
Treatments are limited for this form of atherosclerosis, with options including cholesterol-lowering drugs and extra medications for fluid retention or heart failure. Data were announced at the virtual American College of Cardiology annual conference and published simultaneously in The Lancet.
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.
Researchers have found that a class of commonly-used heart drugs may also improve patients’ responses to anti-cancer immunotherapies called PD(L)1 inhibitors, according to preliminary findings to be presented at the 32th EORTC-NCI-AACR [1] Symposium on Molecular Targets and Cancer Therapeutics, which is taking place online.
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
ET, Monday, November 16, 2020, Cleveland: Cleveland Clinic researchers leading a global clinicaltrial have found that rilonacept, an FDA approved drug for other inflammatory diseases, resolved acute pericarditis episodes and reduced risk of […].
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. months follow up. months follow up.
The decision gave Bayer complete control of BlueRock’s cell therapy pipeline, headed by DA01 and spanning various diseases in the neurology , cardiology , and immunology categories. It looks to carry on with a new class of oral, once-daily, small molecule drugs called Controlled Metabolic Accelerators (CMAs).
Bayer is proud of the approval of vericiguat in Japan and the contribution it has shown in clinicaltrials.”. Food and Drug Administration (FDA) in January 2021 and was recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) in the EU in May 2021.
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.
We are taking bold steps into the future of drug development, investing strongly in areas at the forefront of the biomedical and technological revolution. Strong pipeline with robust late-stage development program and broad potential across indications.
Upon entering the treatment phase, there will be a 16-week ramp-up period during which the amount of study drug is gradually increased to aid the body in acclimating to the treatment. CORE Research Group CORE Research Group is owned and run by a consultant cardiologist and has successfully run clinicaltrials for almost 30 years.
Michael Felker, MD, MHS, FACC, FAHA, FHFSA is Professor of Medicine with tenure in the Division of Cardiology at Duke University School of Medicine. He is Director of Cardiovascular Research at the Duke Clinical Research Institute and Vice-Chief for Clinical Research in the Division of Cardiology.
Scientific Articles & Whitepapers HCPs rely on credible, research-backed content to stay informed about new treatments, drug efficacy, and emerging medical trends. Pharma brands can develop: Whitepapers on clinicaltrials showcasing drug effectiveness. Chatbots answering FAQs on drug safety and usage.
SCORED trial of patients with diabetes and chronic kidney disease is first trial of an SGLT2 inhibitor to show benefit across the full range of albuminuria; SOLOIST shows an SGLT2 inhibitor is safe to start in patients hospitalized with heart failure Boston, MA — Less than a decade ago, the Food and Drug Administration approved […].
The Late-Breaking Trial Data at TVT Prove Sustained Safety and Performance of WATCHMAN FLX Left Atrial Appendage Closure Device. According to analyst views, interventional cardiology sales grew at around 7% in the first quarter of 2021 versus 2020 with structural heart franchise WATCHMAN, ACURATE neo2, and SENTINEL.
FoCus is a pivotal, Phase III, randomised, rater-blinded, multi-centre clinicaltrial designed to evaluate the efficacy and safety of ALXN1840 versus SoC in patients with Wilson disease aged 12 years and older. ALXN1840 has been granted Orphan Drug Designation in the US and EU for Wilson disease. Source link: [link].
Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. market and congratulate all Chiesi team members and partners who supported the clinical process.”. You are encouraged to report negative side effects of prescription drugs to the FDA. 02, 2020 (GLOBE NEWSWIRE) — Chiesi USA, Inc.,
Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) will participate in this “collaborative community” A medical “collaboratory” is a forum in which multidisciplinary private and public sector members work together on medical […].
The investigational drug evinacumab reduced triglycerides in patients with severe hypertriglyceridemia (sHTG) and a history of hospitalizations for acute pancreatitis in a phase 2 global study led by Mount Sinai.
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.
The investigational drug evinacumab reduced low-density lipoprotein (LDL) cholesterol–the so-called “bad” cholesterol–by 50 percent in patients with severe hypercholesterolemia whose condition is resistant to standard treatments, a phase 2 study from the Icahn School of Medicine of Mount Sinai and other global academic sites (..)
The company’s commercial priorities are three-fold: (1) Initially focusing its commercial efforts on rare diseases within its prolific neurology and cardiology franchises (2) pioneer new markets where there are no available treatments (3) create new standards of care where there has been a lack of innovation to optimize patient care.
We did not get a Class II certification for diabetes only, or orthopedics or cardiology; we got a disease-agnostic certification. Now, as we develop new predictive algorithms, whether that is in diabetes, cardiology, respiratory or oncology, we can bring those algorithms to our platform because it is disease-agnostic.
We remain focused on continuing to serve patients, protecting the health and safety of our employees and the communities in which we live and work, and supporting patients in clinicaltrials. The COVID-19 impact has varied by study and program, but there has been little timing impact on fully-enrolled trials.
Dosing is underway in Phase 3 trials of ULTOMIRIS in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), ALXN2060 (AG10) in ATTR cardiomyopathy in Japan , CAEL -101 in AL amyloidosis and ALXN2040 in paroxysmal nocturnal hemoglobinuria (PNH) patients with extravascular hemolysis (EVH).
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.
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.
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