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New VOYAGER PAD Analysis Confirms Consistent Benefit of XARELTO ® (rivaroxaban) Plus Aspirin Following Lower Extremity Revascularization (LER)
TITUSVILLE, NJ, March 5, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from a new prespecified analysis from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefits of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following LER in patients with PAD. Lower extremity revascularization, also called peripheral revascularization, is a procedure that restores blood flow in blocked arteries or veins. This analysis of ...
Source: Johnson and Johnson - March 5, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Data from New VOYAGER PAD Analyses at ACC.22 Reinforce Benefit of XARELTO ® (rivaroxaban) Plus Aspirin in Patients with Peripheral Artery Disease (PAD) and Various Co-Morbid Conditions
RARITAN, N.J., April 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with PAD after lower-extremity revascularization (LER), a procedure that restores blood flow to the legs. Data from the two analyses demonstrate the role that the XARELTO® vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and ...
Source: Johnson and Johnson - April 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

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

Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 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

FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

O-005 Comparison of on-label versus off-label treatment of intracranial aneurysms with the pipeline embolization devices
ConclusionIn real-world practice, off-label uses of PED can achieve similar safety and efficacy to on-label uses, though there may be a slightly higher rate of ischemic complications in off-label uses. Expert judgment is a useful supplement to official guidelines when assessing reasonable PED use beyond its approved indications.Disclosures S. Cler: None. D. Lauzier: None. A. Kansagra: 2; C; Penumbra, Microvention, iSchemaView.
Source: Journal of NeuroInterventional Surgery - July 26, 2021 Category: Neurosurgery Authors: Cler, S., Lauzier, D., Kansagra, A. Tags: Oral abstracts Source Type: research

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

The PARTNER 3 Trial at Two Years: What We Have Learned and What Time Will Tell
Based on data from large, industry-sponsored randomized prospective studies, the US Food and Drug Administration (FDA) has approved both balloon-expandable and self-expanding transcatheter aortic valve replacement (TAVR) devices for use in aortic stenosis patients at low, intermediate, and high risk for surgical aortic valve replacement (SAVR).1-6 High-risk device approval was based on one-year data, which was reasonable due to the actuarial life expectancies of the cohort.1,2 Intermediate-risk approval for the balloon-expandable SAPIEN XT (Edwards Lifesciences, Irvine, CA) system was based largely on data from the Placeme...
Source: Journal of Cardiothoracic and Vascular Anesthesia - May 28, 2021 Category: Anesthesiology Authors: Peter J. Neuburger, Kinjal M. Patel, Prakash A. Patel Tags: Editorial Source Type: research

The PARTNER 3 Trial at 2 Years: What We've Learned and What Time Will Tell
Based on data from large, industry-sponsored randomized prospective studies, the United States Food and Drug Administration (FDA) has approved both balloon-expandable and self-expanding transcatheter aortic valve replacement (TAVR) devices for use in aortic stenosis patients at low, intermediate and high-risk for surgical aortic valve replacement (SAVR).1-6 High-risk device approval was based on 1-year data, which was reasonable due to the actuarial life expectancies of the cohort.1, 2 Intermediate-risk approval for the balloon-expandable Sapien XT (Edwards Lifesciences, Irvine, California) system was largely based on data...
Source: Journal of Cardiothoracic and Vascular Anesthesia - May 28, 2021 Category: Anesthesiology Authors: Peter J. Neuburger, Kinjal M. Patel, Prakash A. Patel Source Type: research

Late-Breaking Data at ACC.21 Show XARELTO ® (rivaroxaban) Plus Aspirin Significantly Reduced Total Ischemic Events in Peripheral Artery Disease (PAD) Patients After Lower-Extremity Revascularization
RARITAN, N.J., May 16, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today presented new data from the Phase 3 VOYAGER PAD study which showed XARELTO® (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone regardless of whether it was the first, second, third, or subsequent event. The primary results of VOYAGER PAD showed that XARELTO® plus aspirin reduced first events by 15 percent among patients with PAD ...
Source: Johnson and Johnson - May 16, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Nerve stimulation could provide new treatment option for most common type of stroke
Research led by a UCLA scientist found that a new nerve stimulation therapy to increase blood flow could help patients with the most common type of stroke up to 24 hours after onset.A study of 1,000 patients found evidence that the technique, called active nerve cell cluster stimulation, reduced the patients ’ degree of disability three months after they suffered an acute cortical ischemic stroke, which affects the surface of the brain.Dr. Jeffrey Saver, director of theUCLA Comprehensive Stroke Center, was the co-principal investigator of the study, which was conducted at 73 medical centers in 18 countries.“We believe ...
Source: UCLA Newsroom: Health Sciences - May 24, 2019 Category: Universities & Medical Training Source Type: news

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