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Total 31 results found since Jan 2013.
Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation
RARITAN, NJ, May 25, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia program is unrivaled as the most comprehensive FXIa clinical...
Source: Johnson and Johnson - May 25, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
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
Inactivated whole-virion SARS-CoV-2 vaccines and long-term clinical outcomes in patients with coronary atherosclerosis disease in China: a prospective cohort study
CONCLUSIONS: Our results indicated no evidence of an increased ischemic or bleeding risk after vaccination with inactivated SARS-CoV-2 vaccine among Chinese patients with CAD, with limited statistical power.PMID:36756815 | DOI:10.1093/cvr/cvad031
Source: Atherosclerosis - February 9, 2023 Category: Cardiology Authors: Huajie Xu Jiaojiao Zheng Xin Zhao Qi Zhou Bing Fan Hongyi Wu Si Zhang Junbo Ge Source Type: research
Real-World Study Confirms Benefit of XARELTO ® (rivaroxaban) for Secondary Prevention of Venous Thromboembolism in Cancer Patients
TITUSVILLE, NJ, December 9, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced observational data from eight years of clinical practice showing that the oral Factor Xa inhibitor XARELTO® (rivaroxaban) is associated with comparable effectiveness and safety to the Factor Xa inhibitor apixaban for the treatment of cancer-associated thromboembolism (CAT) in a broad cohort of patients with various cancer types. Patients with CAT are at a higher risk of venous thromboembolism (VTE), which is the second-leading cause of death in people with cancer.1Data from the Observational Study in Cancer-A...
Source: Johnson and Johnson - December 9, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Colchicine and the combination of rivaroxaban and aspirin in patients hospitalised with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial
Lancet Respir Med. 2022 Oct 10:S2213-2600(22)00298-3. doi: 10.1016/S2213-2600(22)00298-3. Online ahead of print.ABSTRACTBACKGROUND: COVID-19 disease is accompanied by a dysregulated immune response and hypercoagulability. The Anti-Coronavirus Therapies (ACT) inpatient trial aimed to evaluate anti-inflammatory therapy with colchicine and antithrombotic therapy with the combination of rivaroxaban and aspirin for prevention of disease progression in patients hospitalised with COVID-19.METHODS: The ACT inpatient, open-label, 2 × 2 factorial, randomised, controlled trial was done at 62 clinical centres in 11 countries. Patient...
Source: Respiratory Care - October 13, 2022 Category: Respiratory Medicine Authors: John W Eikelboom Sanjit S Jolly Emilie P Belley-Cote Richard P Whitlock Sumathy Rangarajan Lizhen Xu Laura Heenan Shrikant I Bangdiwala Maria Luz Diaz Rafael Diaz Afzalhussein Yusufali Sanjib Kumar Sharma Wadea M Tarhuni Mohamed Hassany Alvaro Avezum Will Source Type: research
New Data From Two Large Studies Reinforce Effectiveness of Dual Pathway Inhibition (DPI) with XARELTO ® (rivaroxaban) Plus Aspirin in Patients with Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD)
RARITAN, N.J., May 23, 2022 – Findings from the XARELTO® (rivaroxaban) Phase 3 COMPASS Long-Term Open Label Extension (LTOLE) study and the XARELTO® in Combination with Acetylsalicylic Acid (XATOA) registry have been published in the European Society of Cardiology’s (ESC) European Heart Journal, Cardiovascular Pharmacotherapy. Additionally, the XATOA registry was presented at the American Congress of Cardiology’s 71st Annual Scientific Session (ACC.22). These studies provide further evidence supporting the role of dual pathway inhibition (DPI) with the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 100 mg...
Source: Johnson and Johnson - May 23, 2022 Category: Pharmaceuticals 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
Progress of thrombus formation and research on the structure-activity relationship for antithrombotic drugs
Eur J Med Chem. 2021 Dec 7;228:114035. doi: 10.1016/j.ejmech.2021.114035. Online ahead of print.ABSTRACTMany populations suffer from thrombotic disorders such as stroke, myocardial infarction, unstable angina and thromboembolic disease. Thrombus is one of the major threatening factors to human health and the prevalence of cardio-cerebrovascular diseases induced by thrombus is growing worldwide, even some persons got rare and severe blood clots after receiving the AstraZeneca COVID vaccine unexpectedly. In terms of mechanism of thrombosis, antithrombotic drugs have been divided into three categories including anticoagulants...
Source: European Journal of Medicinal Chemistry - December 13, 2021 Category: Chemistry Authors: Xiaoan Li Tiantian Guo Qian Feng Tiantian Bai Lei Wu Yubo Liu Xu Zheng Jianzhong Jia Jin Pei Shaoping Wu Yiming Song Yongmin Zhang Source Type: research
Unexplained arterial thrombosis: approach to diagnosis and treatment
We present a structured approach to diagnosis with consideration of common causes, including atherosclerosis and embolism, as well as uncommon causes, including medications and substances, vascular and anatomic abnormalities, systemic disorders, and thrombophilias. We highlight areas of management that have evolved within the past 5 years, including the use of dual-pathway inhibition in atherosclerotic disease, antithrombotic therapy selection in embolic stroke of undetermined source and left ventricular thrombus, the role of closure of patent foramen ovale for secondary stroke prevention, and the thrombotic potential of c...
Source: Atherosclerosis - December 10, 2021 Category: Cardiology Authors: Jori E May Stephan Moll Source Type: research
Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses
This study establishes proof-of-principle for milvexian as a differentiated antithrombotic agent,” said Jeffrey Weitz, M.D., Professor of Medicine & Biochemistry and Biomedical Sciences at McMaster University and Executive Director of the Thrombosis and Atherosclerosis Research Institute.[i] “Furthermore, the consistently low rates of bleeding across a 16-fold range of milvexian doses suggest that it has a wide therapeutic window, which opens the opportunity to explore milvexian across a broad range of patients including those for whom factor Xa inhibitors are underutilized or not indicated.” The trial met both o...
Source: Johnson and Johnson - November 15, 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
