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:8/1/2014)... Aug. 1, 2014  Neuland Laboratories Ltd., (NSE:NEULANDLAB; ... pharmaceutical ingredients (APIs), complex intermediates and ... 85 countries, today announced financial results for the ... June 30, 2014. "Neuland,s results in ... re-prioritization to accommodate certain customer needs, and we ...
(Date:8/1/2014)... Aug. 1, 2014 Arena Pharmaceuticals, Inc. ... corporate update and reported financial results for the ... "We have continued to see encouraging advancements ... 43% quarter-over-quarter increase in estimated total prescriptions and ... mark," said Jack Lief, Arena,s President and Chief ...
(Date:7/31/2014)... -- According to data released today by the Centers for ... Part D premium is expected to remain stable at ... the Pharmaceutical Care Management Association (PCMA) said. ... bright spot in American health care. By offering an ... cutting edge, cost-saving tools like pharmacy networks and home ...
Breaking Medicine Technology:Neuland Labs Reports First Quarter Fiscal Year 2015 Financial Results 2Neuland Labs Reports First Quarter Fiscal Year 2015 Financial Results 3Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2014 Financial Results 2Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2014 Financial Results 3Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2014 Financial Results 4Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2014 Financial Results 5Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2014 Financial Results 6Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2014 Financial Results 7Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2014 Financial Results 8Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2014 Financial Results 9Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2014 Financial Results 10Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2014 Financial Results 11
... R.I., Oct. 15 CVS/pharmacy announced today that its ... in light of manufacturer delays in delivery of seasonal ... MinuteClinic will continue to administer seasonal flu vaccines at ... season with the supply of vaccine replenished as frequently ...
... Inc. (Nasdaq: CYNO ), a leading developer ... systems, today announced that the company will host its third-quarter ... a.m. ET. , On the call, President and Chief Executive ... Officer Timothy Baker will discuss Cynosure,s financial results, as well ...
Cached Medicine Technology:CVS Caremark Announces Updates to Flu Vaccine Program 2CVS Caremark Announces Updates to Flu Vaccine Program 3Cynosure to Announce Third-Quarter 2009 Financial Results on October 27 2
(Date:8/1/2014)... Cannabis use among young people has spiked, ... 17 having used marijuana at least once and 17 percent ... ‘No’ to Drugs, Say ‘Yes to Life,’ volunteers from the ... this summer with factual information about drugs, to help reverse ... “Say ‘No’ to Drugs, Say ‘Yes’ to Life,” volunteers have ...
(Date:8/1/2014)... of Medicine in St. Louis helps explain why brain ... more harmful than similar tumors in females. For example, ... twice as often in males, who suffer greater cognitive ... , The researchers found that retinoblastoma protein (RB), a ... active in male brain cells than in female brain ...
(Date:8/1/2014)... Barbara Bronson Gray HealthDay ... who are obese and work in manufacturing jobs may have significantly ... In a study of 32 people -- half were obese, ... had endurance times that were about 60 percent longer. Obesity ... task performance. Being older -- 50 to 65 ...
(Date:8/1/2014)... 2014 (HealthDay News) -- Almost 140 people die ... in the United States. But there are ... Dawne Gardner, injury prevention coordinator at Cincinnati Children,s ... in a medical center news release. "As ... school, it,s important for parents and children to ...
(Date:8/1/2014)... Summer is here, and with it comes the ... and they can be a pain for dogs. Animal Emergency ... their customers get rid of ticks and prevent them completely. ... the summer, which is why they are so active during ... woodland areas and carry a number of diseases, including lyme ...
Breaking Medicine News(10 mins):Health News:Addressing a Serious Issue Affecting German Teens 2Health News:Study reveals one reason brain tumors are more common in men 2Health News:Obesity Might Slow You Down at Work 2Health News:Obesity Might Slow You Down at Work 3Health News:Expert Offers School Bus Safety Tips 2Health News:Tis the Season for Tick Prevention 2
... TAMPA, Fla. -- Alexander R. A. Anderson, Ph.D., co-director ... and his colleagues, Simon Hayward, Ph.D., at Vanderbilt University ... have received a five-year, $3 million grant from the ... to predict prostate cancer aggressiveness. "Mathematical models have ...
... HealthDay Reporter , THURSDAY, Oct. 20 (HealthDay News) -- The ... worry about an increased risk of brain cancer, new Danish research ... subject finds no more brain tumors among people who had cell ... phones. Although no one study can rule out harm with ...
... HealthDay Reporter , FRIDAY, Oct. 21 (HealthDay News) ... hormone production as the testes and adrenal glands. But those ... new study, showing hormone production in the penis itself, turn ... in both mice and human tissue, revealing that proteins key ...
... new development paths towards a healthier life. New opportunities ... development, industrial biotechnology and environmental technology have been a ... , VTT is one of the organisers of Metabomeeting ... at the end of September. Professor Jeremy K. Nicholson ...
... scientists advances a strategy for taming the side effects ... medications that work by disrupting the activity of certain ... developed at St. Jude. In this study, scientists showed ... activity of genes in a cell signaling pathway regulated ...
... over the years has made it possible for researchers and ... using ionising radiation, for example X-rays. The images ... of water in the body, since the body is largely ... nuclei in water molecules. It can also be used to ...
Cached Medicine News:Health News:Researchers get $3 million National Institutes of Health grant for mathematical models of prostate cancer aggressiveness 2Health News:Cell Phones Don't Raise Brain Cancer Risk, Study Says 2Health News:Cell Phones Don't Raise Brain Cancer Risk, Study Says 3Health News:Research Suggests Penis Might Produce Testosterone 2Health News:Research involving thyroid hormone lays foundation for more targeted drug development 2Health News:Research involving thyroid hormone lays foundation for more targeted drug development 3Health News:New instrument helps researchers see how diseases start and develop in minute detail 2
The Ceracup has a standard profile plastic component with a ceramic insert and the benefit of alumina-alumina contact....
S-ROM acetabular cups provide a variety of geometrical options to help address many anatomical situations and defects....
S-ROM acetabular cups provide a variety of geometrical options to help address many anatomical situations and defects....
The Trident ceramic acetabular system provides several important benefits and meets greater demands of younger, more active patients....
Medicine Products: