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:4/20/2015)... , April 20, 2015   Gateway ... Research and Training Institute today expanded its Naloxone: ... outpatient locations.  A $50,000 grant from the ... research project possible.  The yearlong ... to patients and their family members upon completion ...
(Date:4/20/2015)... 2015  Purdue Pharma, a leading specialty pharmaceutical ... has joined the company as Senior Vice President ... responsibility for all of Purdue,s efforts to acquire ... would benefit from our patient-focused commercial capabilities. ... Purdue President & CEO Mark Timney . ...
(Date:4/20/2015)... 2015 Cardinal Innovations Healthcare Solutions ... high-tech, high-touch service delivery, is featuring its highly ... the National Council for Behavioral Health,s annual National ... 20–22, 2015, at the Gaylord Palms Resort and ... , attracts participants from mental health and addiction ...
Breaking Medicine Technology:Gateway Rehab and the Kenneth S. Ramsey, PhD Research and Training Institute expand Naloxone: Increasing Access, Saving Lives research project to outpatient locations 2Gateway Rehab and the Kenneth S. Ramsey, PhD Research and Training Institute expand Naloxone: Increasing Access, Saving Lives research project to outpatient locations 3Purdue Pharma Names J. Alan Butcher Senior Vice President of Licensing & Business Development 2Cardinal Innovations Highlights its Managed Care Model During National Council for Behavioral Health's Annual Conference 2Cardinal Innovations Highlights its Managed Care Model During National Council for Behavioral Health's Annual Conference 3
... , July 15 Caraco Pharmaceutical Laboratories, Ltd. (NYSE ... , NYSE Amex notified the Company that it was not in ... audit committee be comprised of three independent members. On July ... with Section 803(B)(2)(a) of NYSE Amex Company Guide following the resignation ...
... SAN DIEGO , July 15 ... HealthCare has selected the Allscripts Community Record , provided ... across the health system. Using the Allscripts solution, Sharp,s caregivers ... to a single, unified patient record, bridging gaps that often ...
Cached Medicine Technology:Caraco Pharmaceutical Laboratories, Ltd. Receives Notice Regarding NYSE Amex Continued Listing Standards 2Sharp HealthCare Selects Allscripts Community Record to Deliver End-to-End Health Information Connectivity for San Diego Physicians and Hospitals 2Sharp HealthCare Selects Allscripts Community Record to Deliver End-to-End Health Information Connectivity for San Diego Physicians and Hospitals 3Sharp HealthCare Selects Allscripts Community Record to Deliver End-to-End Health Information Connectivity for San Diego Physicians and Hospitals 4Sharp HealthCare Selects Allscripts Community Record to Deliver End-to-End Health Information Connectivity for San Diego Physicians and Hospitals 5Sharp HealthCare Selects Allscripts Community Record to Deliver End-to-End Health Information Connectivity for San Diego Physicians and Hospitals 6
(Date:4/20/2015)... April 20, 2015 Insuranceautoquote.info has released ... affordable car insurance quotes online . , Affordable ... the best results. Clients should always compare online car ... done on a single website: . http://insuranceautoquote.info ... questionnaire can be completed in a few minutes and ...
(Date:4/20/2015)... PITTSBURGH, PA (PRWEB) April 20, 2015 ... long periods of travel, so an inventor from Longmont, ... to eliminate this problem. , Easy to use, compact ... SOFT LANDING CUSHION keeps a user’s buttocks from becoming ... comfort and pleasure, as well as stimulates blood circulation, ...
(Date:4/20/2015)... (PRWEB) April 20, 2015 Medical Grade ... Sunflower Medical Center in Ruleville, Miss., to help reduce ... four welloStations™ throughout its facilities. The welloStation ... employees, patients, suppliers and others as they enter an ... products and procedural applications offered by MGI to curb ...
(Date:4/20/2015)... 20, 2015 Cannabix Technologies Inc. (CSE: ... Marijuana Breathalyzer for law enforcement and the workplace, is ... available images of its marijuana breathalyzer Alpha prototype and ... Media files and video that show the design and ... at cannabixtechnologies.com . , The Alpha prototype images ...
(Date:4/20/2015)... Insuranceautoquote.info has released a new blog post presenting a list ... an auto insurance policy . , Classic cars ... insurance plan provides financial protection for a vehicle in case ... how much it will cost to repair a certain vehicle. ... cover as their parts are either rare or very costly. ...
Breaking Medicine News(10 mins):Health News:Affordable Auto Insurance Quotes Can Be Found Online, Fast and Easy 2Health News:Medical Grade Innovations Helps North Sunflower Medical Center Reduce Infection Spread with the welloStation™ 2Health News:Medical Grade Innovations Helps North Sunflower Medical Center Reduce Infection Spread with the welloStation™ 3Health News:Medical Grade Innovations Helps North Sunflower Medical Center Reduce Infection Spread with the welloStation™ 4Health News:Cannabix Technologies Inc. Releases New Images of Marijuana Breathalyzer Prototype 2Health News:Cannabix Technologies Inc. Releases New Images of Marijuana Breathalyzer Prototype 3Health News:Cannabix Technologies Inc. Releases New Images of Marijuana Breathalyzer Prototype 4Health News:A Blog Post Presents Vehicles That Are Difficult To Cover By Auto Insurance! 2
... The hot summer attracts children towards water to chill out. Places ... fun. //But youngsters should be very for cautious and always follow ... dangerous situations parents have taken all the safety measures such as ... spas and hot tubs they fail to install the child proof ...
... the consent of patients prior to medical trials, a famous ... approval from the patients. ,Dr Deepak Chitkara, 46, ... inserted "untested" lenses into patients' eyes as part of a ... Rosen Eye clinic, but has since started his own practice. ...
... revealed that gay men who have also been diagnosed as ... their health status to others//. ,The study, the ... work with HIV-positive men who are often uncertain whether to ... the virus that causes AIDS. It was published in the ...
... and Germany have developed new tests that would determiner ... Cinco de Mayo or just having another relaxing day ... thing from fraudulent versions, which are a potential threat ... ,The findings could help provide a "shot" of quality ...
... The provisional fees for admittance into various medical courses ... the medical education and research department// of the Punjab ... other similar medical and paramedical courses. ,Representatives ... for a consultation regarding the actual fees to be ...
... handling a pandemic, state and local health officials would be ... influenza in the U.S. ,While the plans have ... of a pandemic and its transmission, ``the center of gravity ... report said. ,A preliminary $7.1 billion plan was ...
Cached Medicine News:Health News:Hot Tubs and Spas in the News for Safety Measures 2Health News:Gays Have No Regrets 2Health News:Gays Have No Regrets 3Health News:Tequila-The Real Stuff or Not 2Health News:Provisional Fees For Medical Courses Fixed By Punjab Government 2Health News:Bush Unveils Latest Blueprint for Handling Bird Flu Pandemic 2Health News:Bush Unveils Latest Blueprint for Handling Bird Flu Pandemic 3
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: