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Condition: Heart Disease
Management: Food and Drug Administration (FDA)
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Total 49 results found since Jan 2013.
FDA Approves Two New Indications for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, Dec. 20, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have...
Source: Johnson and Johnson - December 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO ® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events
RARITAN, NJ, September 27, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data from the Phase 3 UNIVERSE study showing treatment with XARELTO® (rivaroxaban) in an oral suspension formulation, compared to treatment with aspirin, was associated with numerically fewer blood clots and clinical events strongly associated with blood clots in pediatric patients (aged 2-8 years) who have undergone the Fontan procedure. [1] These findings, which were published this month in the Journal of the American Heart Association and included in a recent New Drug Application submitted to the U.S. F...
Source: Johnson and Johnson - September 27, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
ERLEADA ® (apalutamide) Oral Presentations Demonstrate Importance of Prostate Specific Antigen (PSA) as Key Efficacy Indicator and Show Strong Patient Adherence Rates
September 11, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data demonstrating robust prostate-specific antigen (PSA) response and strong adherence rates in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with ERLEADA® (apalutamide) in the real-world clinical setting. The strong PSA response was also seen in a separate post-hoc analysis that showed a correlation between rapid and deep PSA response and prolonged survival in both metastatic castration-sensitive prostate cancer (mCSPC) and nmCRPC. The post-hoc analysis also suppor...
Source: Johnson and Johnson - September 12, 2021 Category: Pharmaceuticals Source Type: news
Janssen Demonstrates Commitment to Advancing Science and Innovation in the Treatment of Solid Tumors at ESMO Annual Congress
September 8, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than ten data presentations from its lung cancer, bladder cancer and prostate cancer portfolio and pipeline will be featured during the European Society for Medical Oncology (ESMO) Annual Congress 2021 virtual meeting, September 16–21. Further details about these data and the science Janssen is advancing will be made available throughout ESMO via the Janssen Oncology Virtual Newsroom.“With a diverse oncology portfolio and pipeline spanning bladder cancer, lung cancer and prostate cancer, Janssen...
Source: Johnson and Johnson - September 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenita...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Study: Fish Oil Doesn ’ t Seem To Prevent Heart Problems
This study is consistent with earlier trials.
The US Food and Drug Administration approved the fish oil-based drug Vascepa for heart attack and stroke prevention in 2019.
Nissen hopes the FDA will take a look at these studies and reconsider that decision.
“But it’s hard to get something undone once the genie gets out of the bottle,” he said.
An editorial in the journal that accompanies the study written by Dr. Gregory Curfman, assistant professor of medicine at Harvard Medical School, also suggested the FDA should require a postmarketing clinical trial of a high-dose of fish oil, such as Vascepa, vs. corn...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - November 16, 2020 Category: Consumer Health News Authors: CBS Boston Tags: Boston News Health Syndicated CBSN Boston CNN fish oil Source Type: news
Cinnamon May Slow Progression To Type 2 Diabetes, Boston Study Finds
(CNN) — Cinnamon may improve blood sugar control in people with a condition known as prediabetes and may slow the progression to type 2 diabetes, according to a new pilot study of 51 people with elevated blood sugars.
“We are looking for safe, durable and cost-effective approaches to reduce the progression from prediabetes to type 2 diabetes,” said study author Dr. Giulio Romeo, a staff physician at Boston’s Joslin Diabetes Center and the division of endocrinology at Beth Israel Deaconess Medical Center. The study published Tuesday in the Journal of the Endocrine Society.
“Our 12-week study sh...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - July 21, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Health Syndicated CBSN Boston Cinnamon CNN Diabetes Source Type: news
Omega-3 fatty acid therapy for cardiovascular disease: justified or not?
Purpose of review
To discuss the current evidence regarding the relationship between omega-3 fatty acid intake and atherosclerotic cardiovascular disease (ASCVD) risk.
Recent findings
Combined results from randomized controlled trials using low-dosage (≤1.8 g/day of ethyl esters) eicosapentaenoic acid (EPA) or EPA + docosahexaenoic acid (DHA) suggest a small benefit for reducing coronary heart disease risk. The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglyceri...
Source: Current Opinion in Cardiology - June 6, 2020 Category: Cardiology Tags: LIPIDS AND EMERGING RISK FACTORS: Edited by Dimitri P. Mikhailidis and Anthony S. Wierzbicki Source Type: research
Arsenic exposure: A public health problem leading to several cancers
Publication date: Available online 23 November 2019Source: Regulatory Toxicology and PharmacologyAuthor(s): I. Palma-Lara, M. Martínez-Castillo, J.C. Quintana-Pérez, M.G. Arellano-Mendoza, F. Tamay-Cach, O.L. Valenzuela-Limón, E.A. García-Montalvo, A. Hernández-ZavalaAbstractArsenic, a metalloid and naturally occurring element, is one of the most abundant elements in the earth's crust. Water is contaminated by arsenic through natural sources (underground water, minerals and geothermal processes) and anthropogenic sources such as mining, industrial processes, and the production and use of pesticides. Humans are exposed...
Source: Regulatory Toxicology and Pharmacology - November 23, 2019 Category: Toxicology Source Type: research
Arsenic exposure: A public health problem leading to several cancers.
Abstract
Arsenic, a metalloid and naturally occurring element, is one of the most abundant elements in the earth's crust. Water is contaminated by arsenic through natural sources (underground water, minerals and geothermal processes) and anthropogenic sources such as mining, industrial processes, and the production and use of pesticides. Humans are exposed to arsenic mainly by drinking contaminated water, and secondarily through inhalation and skin contact. Arsenic exposure is associated with the development of vascular disease, including stroke, ischemic heart disease and peripheral vascular disease. Also, arseni...
Source: Regulatory Toxicology and Pharmacology : RTP - November 21, 2019 Category: Toxicology Authors: Palma-Lara I, Martínez-Castillo M, Quintana-Pérez JC, Arellano-Mendoza MG, Tamay-Cach F, Valenzuela-Limón OL, García-Montalvo EA, Hernández-Zavala A Tags: Regul Toxicol Pharmacol Source Type: research
1H NMR-Based Metabolomics Reveals Refined-Huang-Lian-Jie-Du-Decoction (BBG) as a Potential Ischemic Stroke Treatment Drug With Efficacy and a Favorable Therapeutic Window
This study was carried out in accordance with the recommendations of Animal Ethics Committee of China Pharmaceutical University. The protocol was approved by Animal Ethics Committee of China Pharmaceutical University.
Author Contributions
JW, MY, and LK conceived the experiments and helped to coordinate support and funding. XF performed the research and drafted the manuscript. SL, YL, and DX participated in the experiments. JW analyzed the data and edited the paper. All authors read and approved the final manuscript.
Conflict of Interest Statement
The authors declare that the research was conducted in the absence of an...
Source: Frontiers in Pharmacology - April 11, 2019 Category: Drugs & Pharmacology Source Type: research
Aspirin Lowers Your Chances of a Heart Attack. But It ’s Not Safe for Everyone, a New Study Says
As medications go, aspirin is often considered a wonder drug. Its pain-relieving, inflammation-taming powers can treat headaches, minor aches and pains and even lower the risk of heart disease, stroke and possibly even dementia.
But all of those benefits may come at a price, according to the latest study to analyze aspirin’s risks and benefits, especially for people who take the drug as a way to prevent having a first heart event. In a study published in JAMA, researchers led by Dr. Sean Zheng at King’s College London found that the risks of aspirin — primarily of bleeding in the stomach and intestinal tr...
Source: TIME: Health - January 23, 2019 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthytime Heart Disease Source Type: news
Aspirin Lowers Your Chances of a Heart Attack. But It ’s Not Safe for Everyone
As medications go, aspirin is often considered a wonder drug. Its pain-reliving, inflammation-taming powers can treat headaches, minor aches and pains and even lower the risk of heart disease, stroke and possibly even dementia.
But all of those benefits may come at a price, according to the latest study to analyze aspirin’s risks and benefits, especially for people who take the drug as a way to prevent having a first heart event. In a study published in JAMA, researchers led by Dr. Sean Zheng at King’s College London found that the risks of aspirin — primarily of bleeding in the stomach and intestinal tra...
Source: TIME: Health - January 23, 2019 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthytime Heart Disease Source Type: news
Prescription Doses of Fish Oil May Lower Heart Attack and Stroke Risk
Omega-3 fatty acids, abundant in fish oil, are known to be good for the heart. Studies have shown that people who eat more fish rich in these fats have lower rates of heart problems and less risk of dying from heart disease compared to those who eat less. Those data have fueled a booming business in over-the-counter fish oil supplements.
In a new study published in the New England Journal of Medicine, and presented at the American Heart Association annual meeting, researchers report that a highly purified version of omega-3 fats, called icosapent ethyl, can lower the risk of a number of heart-related events, including hear...
Source: TIME: Health - November 10, 2018 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthytime Heart Disease omega-3 Source Type: news
Tobacco Product Use Among Adults - United States, 2017.
Abstract
Cigarette smoking harms nearly every organ of the body and causes adverse health consequences, including heart disease, stroke, and multiple types of cancer (1). Although cigarette smoking among U.S. adults has declined considerably, tobacco products have evolved in recent years to include various combustible, noncombustible, and electronic products (1,2). To assess recent national estimates of tobacco product use among U.S. adults aged ≥18 years, CDC, the Food and Drug Administration (FDA), and the National Institutes of Health's National Cancer Institute analyzed data from the 2017 National Health Int...
Source: MMWR Morb Mortal Wkl... - November 9, 2018 Category: Epidemiology Authors: Wang TW, Asman K, Gentzke AS, Cullen KA, Holder-Hayes E, Reyes-Guzman C, Jamal A, Neff L, King BA Tags: MMWR Morb Mortal Wkly Rep Source Type: research
