This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Its becoming more expensive and time-consuming to move a drug from the clinical trial stage to approval. Patient recruitment is the leading driver of costs in clinical trials, 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?
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. Many high school and college students are moving away from the sciences. 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 clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinical trials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe. Meanwhile, the TANDEM trial evaluated a fixed-dose combination of obicetrapib with 10 mg ezetimibe in a similar patient population.
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. In key registration-enabling, placebo-controlled trials, patients received once-monthly doses of lerodalcibep for up to 52 weeks.
Minority ethnicities and regions derive at least as much cardiovascular benefit from lipid-lowering therapies as majority groups despite being underrepresented in clinical trials, according to a study published today in the European Journal of Preventive Cardiology.
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 US Food and Drug Administration (FDA) has approved AOP Health’s landiolol injection, marketed as Rapiblyk, for the treatment of atrial fibrillation (Afib) and atrial flutter in critical care settings. The approval is grounded in data from five randomized, double-blind, placebo-controlled trials involving 317 adults.
Novartis’ attempt to treat cancer with the anti-inflammatory drug canakinumab was always a long shot, but it’s nevertheless a disappointing feeling when things don’t work out. The post Novartis’ canakinumab falls short in phase 3 lung cancer trial appeared first on.
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 US Food and Drug Administration (FDA) has granted Breakthrough Device clearance to Ultromics’ EchoGo Amyloidosis device through its Total Product Lifecycle Advisory Program (TAP). One such study, the PREVAMIC trial conducted in Spain , found that cardiac amyloidosis was present in 20.1
Lifestyle changes and blood pressure-reducing drugs are the mainstays of therapy for hypertension, but despite widespread availability of these approaches, many patients with hypertension are not adequately treated. Hypertension remains poorly controlled worldwide and is becoming more common.
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 Clinical Trials (DCT). Live and On-Demand: Tuesday, May 24, 2022, at 1pm EDT (10am PDT).
Randomized clinical trial 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 clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) (..)
The HAVEN 7 trial showed that emicizumab is both safe and effective in protecting infants from brain bleeds, although concerns were raised about the affordability of this drug. Emicizumab (Hemlibra) was approved by the FDA in 2018 to prevent and reduce bleeding for patients who suffer from hemophilia A.
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
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 UK-based but US-listed biotech licensed rights to AZ’s orally-active neutrophil elastase inhibitor alvelestat for the rare disease alpha-1 antitrypsin deficiency (AATD) five years ago, and has since advanced the project into a phase 2 trial which is due to read out in the second half of this year.
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).
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.
The cholesterol-lowering drug has been classed as a breakthrough therapy for homozygous familial hypercholesterolaemia (HoFH) by the FDA, which is due to deliver a decision on the marketing application by 11 February after a truncated six-month review. Analysts put peak US sales in the region of $200 million to $400 million.
Schenkenberger is especially proud of her clinical trial research work in heart health, noting most new drugs never make it to market. She’s been involved in several trials that have made a difference for patients, including Entresto, a drug that’s been “a big step forward for heart failure patients,” she says.
ET, Monday, November 16, 2020, Cleveland: Cleveland Clinic researchers leading a global clinical trial have found that rilonacept, an FDA approved drug for other inflammatory diseases, resolved acute pericarditis episodes and reduced risk of […].
The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS trial in Japan later this year. An interim look at the results is due later this month.
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., It is then efficiently metabolized by the body.
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. The post RHYTHM AI cleared for large trial of atrial fibrillation mapping tool appeared first on. months follow up.
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.
The US Food and Drug Administration (FDA) recently approved Boston Scientific’s Agent drug-coated balloon (DCB) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease (CAD). Key Features of the Agent Drug-Coated Balloon One of the standout features of the Agent DCB is its TransPax Coating Technology.
Some immunomodulators—drugs that decrease inflammation—have been shown to reduce CV risk in the general population. People with rheumatoid arthritis are at increased risk of cardiovascular (CV) disease, with studies indicating an approximate 50 percent increase in risk of CV events such as heart attack and stroke.
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.
The FDA has granted fast-track status to Bayer’s oral Factor Xia inhibitor asundexian, which is in phase 2 testing as an anticoagulant that could offer safety advantages over current drugs. All three studies are looking at the drug on its own and in combination with anti-platelet therapies like aspirin and clopidogrel.
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. and Europe.
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
MorphoSys in-licensed Monjuvi, which is a humanized Fc-engineered monoclonal antibody against CD19 – the same protein which CAR-T cell therapies target and is in abundance in cancerous B cells, from Xencor in 2010 and is under evaluation in B-cell malignancies in several ongoing combination trials.
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. It looks to carry on with a new class of oral, once-daily, small molecule drugs called Controlled Metabolic Accelerators (CMAs).
Bristol-Myers Squibb is going after a second indication for its first-to-market cardiac myosin inhibitor Camzyos, a drug tipped to be a future blockbuster and the top prospect in the company’s growing cardiovascular pipeline. In the trial, Camzyos or placebo was added to the highest tolerated dose of standard therapy.
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.”. Verquvo (vericiguat) 2.5 Verquvo (vericiguat) was approved by the U.S.
But after giving the patients an unmarked eight-month supply of statins and dummy pills (four bottles of each), the investigators found that 90% of the symptoms reported when taking the real drug endured, even when patients were taking a dummy (placebo) pill. The study received no drug industry funding.
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.
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.
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 clinical trials for almost 30 years.
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.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content