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:9/17/2014)... Switzerland , September 17, 2014 ... is proud to congratulate Biocartis commitment in shipping ... is a long-time investor in Biocartis as part ... Biocartis, fully automated, real-time PCR based molecular ... and easy access to clinical molecular diagnostic information, ...
(Date:9/16/2014)... , 17 settembre 2014 Hologic, ... oggi il lancio in Europa del Tomcat, un ... è una piattaforma multifunzionale completamente automatizzata, progettata per ... inefficienze ed i rischi di errore legati alla ... dello strumento Tomcat di Hologic riduce il carico ...
(Date:9/16/2014)... BEDFORD, Massachusetts , 17. September ... HOLX ), hat heute ... Gerät zur präanalytischen Probenverarbeitung, in Europa ... CE-IVD gekennzeichnete, vollautomatisierte Universalplattform zur Vereinfachung ... erreicht, dass ineffiziente und fehlerbehaftete Arbeitsschritte ...
Breaking Medicine Technology:Debiopharm Diagnostics Portfolio Company Biocartis Ships its First Idylla Instrument 2Hologic annuncia il lancio dello strumento preanalitico Tomcat in Europa 2Hologic annuncia il lancio dello strumento preanalitico Tomcat in Europa 3Hologic stellt in Europa den Tomcat vor, ein neues Gerät zur präanalytischen Probenverarbeitung 2Hologic stellt in Europa den Tomcat vor, ein neues Gerät zur präanalytischen Probenverarbeitung 3
... Researchers at Brigham and Women,s,Hospital found that patients taking ... effects were unrelated to relief from their pain,symptoms. ... examine the addictive,potential of this class of pain medicine, ... 25th Annual Meeting. , In ...
... Lethal ,Super, Strains of C.difficileCHICAGO, Jan. 28 ... scientists at The University of Nottingham are leading a ... one of the most lethal strains of hospital acquired ... technology developed in Nottingham to study the function of ...
Cached Medicine Technology:Study of Cannabinoid Medicine for Pain Found Patients Got 'High,' but Effects Not Related to Pain Relief 2British Midlands University Announces Use of Gene Technology to Fight Lethal Hospital Acquired Infection 2British Midlands University Announces Use of Gene Technology to Fight Lethal Hospital Acquired Infection 3
(Date:9/16/2014)... (PRWEB) September 17, 2014 Retinol is favored ... for anti-aging care. , "Retinol has so many benefits - ... says Kathy Heshelow, founder of Sublime Beauty . "Healthy ... in it." , The Sublime Beauty® Retinol Serum with Vitamin ... ingredients for skin care. The Retinol Serum with ...
(Date:9/16/2014)... City, UT (PRWEB) September 16, 2014 ... Benefits Solution, published new information on transitioning employees ... Zane Benefits, with the Affordable Care Act (ACA) ... businesses will be steering some or all of ... as no surprise. With guaranteed issue plans, coverage ...
(Date:9/16/2014)... September 16, 2014 On Friday, ... two new product extensions, an accompanying mobile application, ... novel marketing tools for their sales force, and ... at their 5th annual national convention, Rise to ... crowd at the Hyatt Regency Orange County was ...
(Date:9/16/2014)... (PRWEB) September 17, 2014 Recently, iFitDress.com, one ... unveiled its latest one shoulder evening gown collection. ... products are available at discounted rates (up to 69% off) ... low shipping fees. , “I am a frequent caller ... time I receive my dress, I feel quite happy. All ...
(Date:9/16/2014)... 2014 Today, Top10BestSEOHosting.com compares ... the USA and announces that HostMonster, Arvixe ... best Windows web hosting companies in the ... clients high quality WordPress hosting (including VPS ... , HostMonster provides outstanding customer support and ...
Breaking Medicine News(10 mins):Health News:Retinol, the Gold Standard in Skin Care, Available in a Serum with Vitamin C from Sublime Beauty®; Now 30% Off 2Health News:Zane Benefits Publishes New Information on Transitioning Employees to Individual Health Insurance 2Health News:New Products Announced at Jusuru International’s R2E14 National Convention 2Health News:New Products Announced at Jusuru International’s R2E14 National Convention 3Health News:New Products Announced at Jusuru International’s R2E14 National Convention 4Health News:iFitDress.com: One Shoulder Evening Gown Collection Unveiled Online 2Health News:Best Windows Web Hosting Suppliers Recommended By SEO Hosting Review Site Top10BestSEOHosting.com 2
... that created waves among the public was questioned as they ... proteins in their daily diet. ,Scientist at ... book on this diet. This best seller sold half ... that 30-35% of one’s energy requirements should be provided by ...
... Aid) was at last implemented in areas close to Long ... feelings of anxiety and joy regarding the concept. // ... just going to add to it," said Greg Jackson, at ... ,A very small number of customers actually approached pharmacists on ...
... nudged away from the plates of food connoisseurs ... its place//. ,This seems evident from the response ... the ongoing seafood festival in Chandigarh these days. ... with the delicious "butter chicken" and "tandoori chicken", the ...
... who use oral contraceptive pills can lose their sex drive ... according to a recent study//. , ,Loss of libido, ... known as side effects of the pill. A previous research ... normal within four weeks of discontinuation. ,But the ...
... Jack Black has revealed he grew up in a weird ... by becoming its members//. ,According to contactmusic.com, Black told ... he was a child, where everyone was encouraged to bare ... life was deeply affected by the cult sessions because his ...
... Guwahati: The next time you can't control the urge to have ... hop over to the nearest post office and get it over ... who swear by the mesmerizing aroma of a blend produced in ... Assam, will now have access to their favorite tea in a ...
Cached Medicine News:Health News:New protein diet program questioned. 2Health News:Medicare Queries Expected To Increase Over Time 2Health News:Punjabis Transfer Taste From Chicken To Prawns 2
Castroviejo "HM" Micro Needle Holder with Tungsten-Carbide Inserts, with catch. Serrated....
Curved with catch....
Clinical micro clamps by Acland. Black finish. It provides impressive security in use, both against slippage and against leakage due to controlled closing force and working grip surface....
Medium weight bone cutter....
Medicine Products: