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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

1 Ventricular assist devices: developments in asia and global outlook for the next 10 years
The advent of left ventricular assist systems to support patients with advanced-stage heart failure has been a 50 year odyssey, now available broadly to such patients.1 Engineering advances have ushered in an era of small, durable devices that can be fully implanted within the chest. Yet, haemocompatibility related adverse events, which emanate from the interaction between the device and the patient they support are manifest principally in increased stroke rates, de novo device thrombosis requiring replacement and in gastrointestinal bleeding (a peculiar adverse event resulting from the unnatural physiology of continuous f...
Source: Heart Asia - April 24, 2019 Category: Cardiology Authors: Mehra, M. R. Tags: Keynote Lecture Source Type: research

Comorbidities and Biomarkers Vary between United States and Japanese LVAD Patients
Left ventricular assist device (LVAD) outcomes differ between Japan and US. While GI bleeding is common in US and rare in Japan, stroke and driveline infections are more common in Japan than US. The aim of this study was to explore whether inflammatory and angiogenesis biomarkers can explain these differences.
Source: The Journal of Heart and Lung Transplantation - March 16, 2019 Category: Transplant Surgery Authors: T. Imamura, A. Nguyen, D. Nitta, T. Fujino, L. Holzhauser, D. Rodgers, S. Kalantari, B. Smith, J. Raikhelkar, N. Narang, B. Chung, I. Ebong, C. Juricek, P. Combs, D. Onsager, T. Song, T. Ota, V. Jeevanandam, G. Kim, G. Sayer, M. Ono, N. Uriel Tags: 1065 Source Type: research