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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 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

Neuroimmunology of Human T-Lymphotropic Virus Type 1-Associated Myelopathy/Tropical Spastic Paraparesis
Conclusion Recent advances in research on HTLV-1 provide better understanding of the molecular pathogenesis and mechanisms of HAM/TSP, and several clinical trials of novel therapies for patients with HAM/TSP have been initiated. However, long-term improvement of motor disability and quality of life still have not been achieved in HAM/TSP patients, and the clinical management remains challenging. Given that HAM/TSP is characterized by activated T-cells in both the periphery and CNS, studies in HAM/TSP will be highly informative for clarifying the pathogenesis of other neuroinflammatory disorders such as multiple sclerosis....
Source: Frontiers in Microbiology - April 23, 2019 Category: Microbiology Source Type: research

Lower-extremity Dynamometry as a Novel Outcome Measure in a Double-blind, Placebo-controlled, Feasibility Trial of Intravenous Immunoglobulin (IVIG) for HIV-associated Myelopathy
Conclusion: We conclude that an adequately powered clinical trial of IVIG for HIVM would likely require a prolonged recruitment period and multiple participating sites. Lower limb dynamometry is a useful outcome measure for HIVM, which might also be useful in other HIV-related gait disorders. KEYWORDS: Dynamometry, intravenous immunoglobulin (IVIG), human immunodeficiency virus (HIV), myelopathy INTRODUCTION Human immunodeficiency virus (HIV)-associated myelopathy (HIVM) is a rare but well-described neurologic complication of HIV; it was first described early in the acquired immunodeficiency syndrome (AIDS) epidemic, and i...
Source: Innovations in Clinical Neuroscience - February 1, 2018 Category: Neuroscience Authors: ICN Online Editor Tags: Assessment Tools Current Issue Demyelinating Disease Movement Disorders Neurodegenerative Disease Neurology Original Research Primary Care Technology Trial Methodology Dynamometry human immunodeficiency virus (HIV) intravenous immu Source Type: research