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:11/28/2014)... QC , Nov. 28, 2014 /CNW Telbec/ - Ergoresearch ... and known under the « Équilibre, orthèses et ... Ended on September 30, 2014. All dollar amounts in the ... for the first quarter of fiscal year 2015 ended this ... by 2,1 % compared to revenues of $ 4 227 942 ...
(Date:11/28/2014)... LOS ANGELES , Nov. 28, 2014 According ... Americans over the course of their lifetime. For many, these ... chronic pain that is caused by a variety of factors. ... disc, surgery may be the best option. While there are ... Laser Discectomy performed by Seyed M. Rezaian , M.D., ...
(Date:11/28/2014)... Nov. 28, 2014  Valeant Pharmaceuticals International, Inc. ... announced that its wholly owned subsidiary, Valeant Pharmaceuticals ... of its outstanding 6.875% Senior Notes due 2018, ... on December 29, 2014 and has mailed an ... the redemption, approximately US$500 million aggregate principal amount ...
Breaking Medicine Technology:First Quarter Results fiscal year ended September 30, 2015 - Ergoresearch reports its results for the quarter ended September 30, 2014. 2First Quarter Results fiscal year ended September 30, 2015 - Ergoresearch reports its results for the quarter ended September 30, 2014. 3First Quarter Results fiscal year ended September 30, 2015 - Ergoresearch reports its results for the quarter ended September 30, 2014. 44 Advantages of Laser Back Surgery When Fixing a Herniated Disk 2Valeant Announces Redemption of US$445.0 Million Aggregate Principal Amount of its Outstanding 6.875% Senior Notes due 2018 2
... fewer products in the pipeline and more at the ... commercial life of mature brands are critical to today,s ... as many as 10 years and billions of dollars ... To help biopharmaceutical companies more effectively ...
... Mass., Feb. 24, 2012  Haemonetics Corporation (NYSE: HAE ... Company effective March 5, 2012 as Vice President of ... ) Mr. Helsel, age 48, was with ... was Vice President of Operations for the Surgical Solutions ...
Cached Medicine Technology:Report Delivers ROI Analysis on Key Lifecycle Management Strategies Utilized by the Pharmaceutical Industry 2Dave Helsel Joins Haemonetics as Vice President of Global Manufacturing 2
(Date:11/28/2014)... Lunadress.co.uk, one of the world’s leading suppliers of wedding ... fashionable white prom gowns. These new LunaDress Prom ... The company provides a big discount of up to ... orders over 99 pounds. , LunaDress provides excellent customer ... needed. The kind experts will explain the related problems ...
(Date:11/28/2014)... November 29, 2014 iFitDress.com is a ... many kinds of beautiful special occasion gowns for the ... of teal cocktail dresses in its online store. The ... to 75% off. , According to the sales manager ... by iFitDress.com are very popular in the international market. ...
(Date:11/28/2014)... TideStore.com , has taken a different ... and other fashion items recently. Its 2014 Cyber Monday Sales ... The special offer is valid during Nov. 30 – Dec. ... outwears, charming dresses, shining prom shoes, essential women’s accessories, sexy ... offering many trendy clothes and fashion accessories. Its items are ...
(Date:11/28/2014)... Tbdress.com has recently announced its ... Nov. 28, 2014. The special offer will provide ladies ... at greatly discounted prices. , The website of ... celebrated generally on December 25 by billions of people ... are always provided in December.” , Tbdress.com is ...
(Date:11/28/2014)... TX (PRWEB) November 29, 2014 ... provides comprehensive information on the therapeutic development for ... stages, therapeutics assessment by drug target, mechanism of ... type, along with latest updates, and featured news ... involved in the therapeutic development for Poxvirus Infections ...
Breaking Medicine News(10 mins):Health News:LunaDress.co.uk: New White LunaDress Prom Gowns Online for Sale Now 2Health News:Discounted Teal Cocktail Dresses From Famous Dress Supplier iFitDress.com 2Health News:2014 Special Monday Sales from TideStore.com 2Health News:Tbdress.com Announced Its Christmas Eve Sales 2Health News:Poxvirus Infections and Vestibular Diseases Pipeline Market Drugs and Companies Review H2 2014 2Health News:Poxvirus Infections and Vestibular Diseases Pipeline Market Drugs and Companies Review H2 2014 3Health News:Poxvirus Infections and Vestibular Diseases Pipeline Market Drugs and Companies Review H2 2014 4
... -- Some women who inherit the BRCA1 or BRCA2 breast ... with breast cancer nearly a decade earlier than those who ... Researchers examined the family trees of 128 breast or ... determine the origins of the patients, cancer genes. "No ...
... around the world are reporting they are burned out and ... Pennsylvania School of Nursing,s Center for Health Outcomes and Policy ... Between 20 to 60 percent of nurses reported ... International Journal for Quality in Health Care , which ...
... of South American songbirds completed by the Department of ... Natural History, has discovered these birds differ dramatically in ... which indicates they are on the road to becoming ... show that species could change, that they were not ...
... Copenhagen have explored the active principles of a Danish mushroom ... particularly toxic towards cancer cells. The goal is to synthesise ... in future drug development. Asia has a long ... products. Many substances found in fungi are today registered as ...
... INDIANAPOLIS -- The health care system in the United States ... to the bedside, how to ensure more equitable use of ... how to pay for that care. The 10th ... of the journal Medical Care tackles key conceptual ...
... Over the past quarter century in Australia, cancer incidence rates ... are some of the findings of a recent study published ... Compared with any other disease group, cancer has ... two Australians developing cancer and one in five dying from ...
Cached Medicine News:Health News:Family Tree May Affect Diagnosis Age in Some Breast Cancers 2Health News:To keep nurses, improve their work environments 2Health News:Danish mushroom inspires cancer researchers 2Health News:Danish mushroom inspires cancer researchers 3Health News:Journal supplement presents strategies for introducing health care delivery innovation 2Health News:Study sheds light on cancer burden in Australia 2
... Aerosol Resistant Tips offer a safe alternative ... are designed for applications such as PCR(a), ... addition, ART Tips are excellent for tissue ... studies. ART Tips prevent aerosol contaminants and ...
... LBP Processor is a primary component of ... accessioning, processing, sampling, and slide preparation ... The MonoPrep LBP Processor produces high-quality sample ... broad range of cytology specimen types. It ...
... Like all Gilson disposable ... in a sterilized version. Each ... in medical device-quality plastic to ... Sterilization is guaranteed by the ...
200 L, Racked, Pre-sterilized, 96 tips/rack Recommended for 20, 25, 50, 100 and 200 L pipettes. Can also be used with 300 L pipettes when pipetting 200 L or less....
Medicine Products: