Navigation Links
Simultaneous Applications Submitted to FDA and EMA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder
Date:9/3/2013

RARITAN, N.J., Sept. 3, 2013 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") announced the simultaneous submissions of a Biologic License Application (BLA) to the United States Food and Drug Administration (U.S. FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for siltuximab for the treatment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.

MCD is a rare disorder in which lymphocytes, a certain type of white blood cells, are over-produced and lead to enlargement of lymph nodes.1, 2 This can cause a variety of symptoms and weaken the immune system, making it hard to fight infection. Infections in people with MCD can be very serious and may even be fatal.3 Currently, there are no approved treatments in the U.S. or European Union (EU) for this rare blood disorder.

"We're proud of our work on siltuximab. As a rare disease with a small patient population, MCD is an area of significant unmet need," said Peter F. Lebowitz, M.D., Ph.D., global oncology therapeutic area head, Janssen. "Siltuximab works by targeting interleukin-6 which appears to be the critical driver of this disease. By focusing on core biologic mechanisms, we now have the potential of helping patients with a condition that is challenging to treat."  

Siltuximab has been granted orphan drug status in MCD in the U.S. and EU. The siltuximab regulatory submissions include data from a randomized, multi-national, double-blind, placebo-controlled study (MCD2001) and data from two non-randomized supportive studies. The MCD2001 study assessed the efficacy and safety of siltuximab plus best supportive care (BSC) compared with placebo plus BSC in patients with MCD.4 In the study, 79 patients were randomly assigned in a 2:1 ratio to one of the two treatment
'/>"/>

SOURCE Janssen Research & Development, LLC
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. First Large-Scale Population-Based Study in the U.S. Shows Hologics 3D Mammography (Breast Tomosynthesis) Significantly Reduces Recall Rates While Simultaneously Improving Cancer Detection
2. Philips IMR offers new capabilities to simultaneously reduce CT Radiation and enhance image quality
3. Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
4. Rubicon Genomics Launches ThruPLEX™ Family of Sample Preparation Products for Next Generation Sequencing Applications
5. Philips demonstrates innovations in nuclear medicine imaging with a comprehensive portfolio of NM applications for IntelliSpace Portal
6. Clinical Safety Data for ChromaDex®s Patented pTeroPure® (pterostilbene) Released at 6th World Congress on Polyphenols Applications in Paris
7. UltraTape announces Cleanroom Labels for Cryogenic Laboratory applications
8. New, Affordable Flow Cytometer Cell Sorter Expands Access to Wider Range of Life Science Applications
9. New Wireless Keyboard Rechargeable, Washable for Healthcare Applications
10. Frost & Sullivan: Label-Free Technology is a High Potential Market with Myriad Unexplored Applications
11. Radiotherapy Devices Market By Technology, Applications & Products (2011 - 2016)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/6/2015)... LAKE FOREST, Ill. , July 6, 2015 ... private equity firm focused exclusively on the healthcare ... acquisition of TIDI Products ("TIDI" or the "Company"). ... , TIDI was once primarily a manufacturer ... acquisition program and internal initiatives, TIDI has expanded ...
(Date:7/6/2015)... Calif. , July 6, 2015  Protiviti, a ... 2015 Internal Auditing around the World publication ... has analyzed and reported on the evolution of the ... from around the globe as a means to providing ... understanding of this strategic business function. The ...
(Date:7/6/2015)... YORK , July 6, 2015 E-QURE ... Chairman, will present live at VirtualInvestorConferences.com on July 9, ... EDT LINK: http://tinyurl.com/e-qure-presentation This ... are invited to ask the company questions in real-time ... the association,s "virtual trade booth." If attendees are not ...
Breaking Medicine Technology:RoundTable Healthcare Partners Acquires TIDI Products 2RoundTable Healthcare Partners Acquires TIDI Products 3New Edition of Internal Auditing Around the World from Protiviti Explores Changes and Trends 2E-QURE Corp to Webcast, Live, at VirtualInvestorConferences.com July 9 2
(Date:7/6/2015)... ... July 06, 2015 , ... MD Now, the leading and fastest-growing urgent care ... urgent care center will serve residents and visitors in the Cutler Bay area, giving ... 22nd South Florida location, the new facility will be the fourth to serve Miami-Dade ...
(Date:7/6/2015)... ... July 06, 2015 , ... The School of Public Health ... a three-year effort to reduce rates of diabetes and cardiovascular disease in African-American ... the Morehouse School of Medicine’s Prevention Research Center and the Satcher Health Leadership ...
(Date:7/6/2015)... Beach, Florida (PRWEB) , ... July 06, 2015 ... ... center solutions, announced today that Randstad Technologies selected Aspect Software Unified IP contact ... in the United States, selected Aspect Unified IP as its future call center ...
(Date:7/6/2015)... Akron, OH (PRWEB) , ... July 06, 2015 , ... ... Home Health and Hospice received the Music & Memory Certification for hospice patients ... bringing the power of music not only to patients but also to their families ...
(Date:7/5/2015)... ... 2015 , ... City Sports, the Boston-based specialty sporting goods retailer, has renewed ... first-time triathletes this summer with ethos, the owner and operator of the Boston Triathlon. ... 6:00 p.m. at the North End Greenway. The event will help new triathletes prepare ...
Breaking Medicine News(10 mins):Health News:MD Now Urgent Care Opens its Fourth Miami-Dade County Facility in Cutler Bay 2Health News:MD Now Urgent Care Opens its Fourth Miami-Dade County Facility in Cutler Bay 3Health News:Georgia State, Morehouse Partner To Tackle Diabetes, Heart Disease In Atlanta’s Minority Communities 2Health News:Aspect Software Unified IP, Hosted by Promero, Selected by Randstad Technologies 2Health News:Aspect Software Unified IP, Hosted by Promero, Selected by Randstad Technologies 3Health News:Music & Memory Program Brings Joy and Excitement to Hospice Patients 2Health News:Music & Memory Program Brings Joy and Excitement to Hospice Patients 3Health News:Music & Memory Program Brings Joy and Excitement to Hospice Patients 4Health News:Sporting Goods Retailer City Sports Renews Partnership with Boston Triathlon 2Health News:Sporting Goods Retailer City Sports Renews Partnership with Boston Triathlon 3
... Gift to The Leukemia & Lymphoma SocietyWHITE PLAINS, N.Y., April ... small, that mothers perform on behalf of their children and ... to do something special to pay tribute to mothers.Consider the ... There is nothing more terrifying for a mother than to ...
... Md., April 20 The following was released today by ... Ride for Dystonia - Debbi Mack and the Dystonia ... -- host the first Freedom Ride for Dystonia ... raise dystonia awareness and find a cure for this rare, ...
... work on research in molecular biology and physical sciences. This effort ... , ... Toronto, Ontario (PRWEB) April 20, 2009 -- ... team is world-wide, but mainly based in Europe and Canada. The ...
... questions people ask when choosing a Social Security representative , ... ... disability applicants can see benefits when they hire a representative to ... of thousands of people in the Social Security Disability Insurance ...
... Research Council (FRC) President Tony Perkins today released ... across the street from infamous late-term abortionist Dr. ... http://www.newscom.com/cgi-bin/prnh/20080930/FRCLOGO )Perkins, ... life, urged opposition to the nomination of Kansas ...
... the University of California, San Diego and the Moores UCSD ... predict the aggressiveness of an often difficult-to-treat form of leukemia. ... the blood are an indicator that chronic lymphocytic leukemia (CLL) ... be aggressive and in need of immediate treatment. , ...
Cached Medicine News:Health News:This Mother's Day Celebrate a Mother's Love 2Health News:Maryland Mystery Author Organizes Fundraising Ride for Rare Neurological Disorder 2Health News:More Social Security Disability Applicants Are Seeking Representation 2Health News:More Social Security Disability Applicants Are Seeking Representation 3Health News:More Social Security Disability Applicants Are Seeking Representation 4Health News:More Social Security Disability Applicants Are Seeking Representation 5Health News:More Social Security Disability Applicants Are Seeking Representation 6Health News:FRC's Tony Perkins Challenges Sebelius' Integrity, Deep Ties to Late-Term Abortionist George Tiller 2Health News:New biomarker may predict leukemia aggressiveness 2
GenuTrain P3 is a support that centers the patella during joint movement....
Comprifix Knee is a comfortable, lightweight, anatomically knitted knee support with an incorporated donut shaped insert for the reduction of pain and swelling....
Ezy Wrap® Knee Immobilizer is durable blue duck canvas laminated to a foam liner. Sewn-in aluminum medial/lateral stay and three contoured posterior stays. Loop-lock contact closure. Hand wash, a...
... Orthosis Custom-fitted static-progressive orthosis ... Goniometer version has calibrated ... metal contacts skin. Includes ... bag. One size fits ...
Medicine Products: