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Its becoming more expensive and time-consuming to move a drug from the clinical trial stage to approval. The ACT team has started to pilot this technology in other disease areas, including cardiology more broadly, endocrinology, oncology, and gastroenterology. They focus on team-based models and scalable applications.
Drugs from Ionis and Arrowhead Pharma that block apolipoprotein C-III (apoC-III) have shown their value in treating diseases associated with elevated triglyceride levels in two studies presented at the American College of Cardiology annual congress.
Nearly 3,000 healthcare providers will benefit, as Shields’ broad payer network and access to limited distribution drugs will offer patients more treatment options and cost-saving support. This partnership could aid consistency in specialty drug access despite such supply disruptions. Sutter Health has been enabling its own $67.8
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?
In this issue: A reality check on Express Scripts’ purported “cost-based” pharmacy network Mark Cuban explains how and why the PBM market will change Why two drug prices are better than one Pharmacists sing the retail pharmacy shakeout blues Plus, two Philly legends meet at a cardiology conference! d/b/a Drug Channels Institute.
An automated system that flags which patients could most benefit from an underused yet life-saving cardiologydrug more than doubled new prescriptions, according to a pilot program test by researchers at NYU Grossman School of Medicine.
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. He also noted that the drug will be entering a rapidly growing global PCSK9 market that is projected to reach $5 billion in 2025 and $10 billion by 2030.
The legacy product now lies outside Bayer’s core areas of cardiology, oncology, haematology, ophthalmology, women’s health and radiopharmaceuticals, and the funds raised from the sale will support the “ongoing transformation of Bayer’s pharma business to focus on key areas of future medical innovation”, said the company.
NEW ORLEANS — Aptly or paradoxically, thousands of the world’s leading cardiologists descended on the home of beignets, bouillabaisse, and beers sold to-go for a weekend-long dive into the latest developments in the science of keeping hearts beating healthily.
People who used marijuana daily were found to be about one-third more likely to develop coronary artery disease (CAD) compared with people who have never used the drug, according to a study presented at the American College of Cardiology's Annual Scientific Session Together With the World Congress of Cardiology.
Low-dose combination (LDC) antihypertensives consisting of three or four blood pressure (BP)-lowering drugs are more effective for lowering BP compared with monotherapy, usual care, or placebo, according to a review published online April 26 in JAMA Cardiology.
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. who intend to evaluate a drug, biologic, medical device, or food for medical purposes that targets a rare disease in a clinical trial. By Sarah Wicks & James E.
Safety assessments also indicated that lepodisiran was well-tolerated, with no serious adverse events related to the drug reported. The Phase II results were presented at the American College of Cardiology 2025 Scientific Sessions. Meanwhile, oral drugs for lowering Lp(a) are also in the works, including from Lilly.
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.
Yet enrollment of ethnic minorities in NIH clinical trials 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 clinical trial diversity and cardiovascular health for all.
GLP1 receptor agonists—a class of diabetes medications—are associated with fewer major adverse cardiovascular events than another type of diabetes drug (DPP4 inhibitors) in older veterans with no prior heart disease.
Madrid, Spain – 21 May 2022: A voice analysis app used by heart failure patients at home recognises fluid in the lungs three weeks before an unplanned hospitalisation or escalation in outpatient drug treatment. The late breaking research is presented at Heart Failure 2022, a scientific congress of the European Society of Cardiology (ESC).1
Sophia Antipolis, 25 September 2020: Short-term hydroxychloroquine treatment is not associated with lethal heart rhythms in patients with COVID-19 who are risk assessed prior to receiving the drug. That’s the finding of research published today in EP Europace, a journal of the European Society of Cardiology (ESC).1
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.
NEW YORK, NY (July 26, 2021)–Two types of drugs that are recommended as a first treatment for patients with high blood pressure were found equally effective in improving cardiovascular outcomes, but the more popular type causes slightly more side effects, finds a multinational observational study led by researchers at Columbia University Vagelos (..)
One type of white blood cell—neutrophils—is of particular interest to Fan and at the heart of groundbreaking research he is leading into the novel use of a leukocyte-inhibiting drug to reduce tissue damage in patients undergoing coronary catheterization.
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.
Unger has joined the firm as a Principal Drug Regulatory Expert. Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (“CDER”). He completed his cardiology training at The Johns Hopkins Hospital in 1987.
When compared to cocaine exposure alone, cocaine and ethanol exposure in emergency department (ED) patients with acute drug overdose was significantly associated with higher occurrence of cardiac arrest, higher mean lactate concentrations, and lower occurrence of myocardial injury.
Patients with pulmonary arterial hypertension (high blood pressure in the arteries that supply the lungs, also called PAH) had approximately double the reduction in pulmonary vascular resistance (PVR) if they took the PAH medications macitentan (10 mg) and tadalafil (40 mg) together in a single tablet rather than either drug alone, according to research (..)
The US Food and Drug Administration (FDA) recently cleared HeartBeams system , recognizing it as the first cable-free ECG device capable of capturing heart signals from three distinct directions. A physician reviews the data alongside the patients medical history, helping to determine the next steps in care.
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).
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.
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.
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.
Drugs prescribed to high-risk stroke patients are costing the NHS hundreds of millions each year – but they are so effective, the service is actually saving money.
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). Cardiac amyloidosis, a serious and often underdiagnosed heart condition, poses significant diagnostic challenges even for experienced clinicians.
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
Credit: Mitsuhiko Yamada MD, PhD., Department of Molecular Pharmacology, Shinshu University School of Medicine, Japan Researchers have identified a new druggable target for heart failure in neonates and infants, a condition for which there has been no specific treatment.
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.
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 drugs were administered open label and all patients were given a low dose of aspirin. The study drug was mailed directly to participants, and at the end of the trial participants were instructed to destroy the drug. The trial took place at 64 sites, and randomized 863 patients.
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.
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.
It screens for inherited genetic conditions across various medical areas, including oncology and cardiology, hearing and vision loss, infertility, endocrinology, gastroenterology, mental and behavioral health, drug responses, sleep, nutrition, exercise and diet.
15, 2020 /PRNewswire/ — Seattle Gummy Company’s breakthrough gummy drug program, which delivers Active Pharmaceutical Ingredients (APIs) in its innovative gummy matrix, recently won its first Investigational New Drug Application (IND) approval from FDA on the company’s allergy gummy medication, designated as IND 140312.
Novartis’ cholesterol drug inclisiran has hit a speed bump with the FDA, which has rejected the potential blockbuster because a manufacturing facility has yet to be inspected. The European Commission has already approved the drug under the brand name Leqvio earlier this month following backing from the CHMP regulatory committee.
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