Navigation Links
Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA
Date:2/4/2008

HORSHAM, Pa., Feb. 4 /PRNewswire/ -- Centocor, Inc. announced today that the Biologics License Application (BLA) for ustekinumab (CNTO 1275) has been accepted for review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Ustekinumab is a new, human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with some immune-mediated inflammatory disorders, including psoriasis.

"We are pleased by the FDA's acceptance of our Biologics License Application for review of ustekinumab," stated Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc. "Ustekinumab has yielded promising efficacy and safety results in Phase 3 clinical trials, and we look forward to working closely with the FDA during their ongoing review of this potential new treatment for psoriasis."

Centocor, Inc. announced that it had submitted the BLA for ustekinumab in December 2007 based on its comprehensive development program including data from two large Phase 3 multicenter, randomized, double-blind, placebo- controlled trials involving nearly 2,000 patients that evaluated the safety and efficacy of ustekinumab in the treatment of moderate to severe plaque-type psoriasis. The primary endpoint of both studies was the proportion of patients who achieved at least a 75 percent reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75). Acceptance of the BLA filing does not mean that a license has been issued for this product nor does it represent any evaluation of the adequacy of the data submitted in the BLA. In December 2007 the Marketing Authorization Application (MAA) for ustekinumab was submitted in Europe and is currently under review by the European Medicines Agency (
'/>"/>

SOURCE Centocor, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Medarex Announces Extension of Broad Antibody Development Relationship with Centocor
2. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
4. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
5. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
6. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
7. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
8. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
9. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
10. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
11. Angiotech announces additional diameters of sutures to further expand its Quill(TM) SRS PDO product line
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... Date: Friday, April 11, 2014 , Time: 6 p.m. ... Road, Warrington, Pa. , Details: The Hepatitis B ... a cure for hepatitis B and improving the quality of ... Ball on Friday, April 11 at Warrington Country Club in ...
(Date:1/14/2014)... owners drew up their lists of New Year,s resolutions for 2014, ... my furry companion." Nowadays there are pet salons, dog and cat ... the little canine or feline darlings along wherever mommy or daddy ... toys at the pet store. But anyone who has ever lived ...
(Date:1/14/2014)... iLab Solutions, the leader in core facility management software, today ... In this role, Michelle will work with current and potential ... development of iLab products. Her main goal will be to ... scientific community by offering the most advanced, user-friendly, and high-impact ...
(Date:1/14/2014)... Kinaxis ®, provider of RapidResponse ®, a cloud-based supply ... ( S&OP ) service, is proud to be a gold ... held at the Hilton San Diego Bayfront, January 30 – ... Kaszas , Director of Supply Chain at Amgen, as she ...
Breaking Biology Technology:Hepatitis B Foundation to Host Annual Crystal Ball Gala 2New Year's Resolution: Give Pets the Gift of Top-Notch Health Care 2iLab Solutions Announces Michelle Detwiler as the New Director of Product Strategy 2Event Alert: Kinaxis Customer to Present at the Biomanufacturing Summit "Supply Chain: Improving Network Effectiveness" 2
... TIME: 8:30 a.m. Eastern Time HOST: Dr. Candace ... Kendle, Chairman and CEO, ... conference call and simultaneous webcast Oct. 31,at 8:30 a.m. Eastern Time to ... session will follow. (Logo: http://www.newscom.com/cgi-bin/prnh/20030429/KNDLLOGO ) Webcast Instructions ...
... Texas, Oct. 10 Luminex Corporation,(Nasdaq: LMNX ) ... on Wednesday, October 24, 2007. Results are scheduled for ... a conference call to discuss the operating,highlights and financial ... October 25, 2007, at 8:00 a.m. Eastern time. ...
... Campbell Alliance, the leading,management consulting firm specializing in ... was recognized as one of the best,places to work ... by the,Triangle Business Journal, ranking third among midsize companies. ... Business Journal,s annual Best,Places to Work luncheon and awards ...
Cached Biology Technology:Kendle Invites You to Attend Its Third Quarter 2007 Earnings Conference Call and Webcast 2Luminex Corporation Third Quarter Earnings Release Scheduled for October 24, 2007 2Luminex Corporation Third Quarter Earnings Release Scheduled for October 24, 2007 3Campbell Alliance Named 'Best Place to Work' by Triangle Business Journal 2
(Date:4/16/2014)... have identified a new syndrome called "osteosarcopenic obesity" that ... with obesity. , "It used to be the thinking ... would be because the bones were supporting more weight," ... at Florida State. "But, that,s only true to a ...
(Date:4/16/2014)... Nicolas Doucet of the Centre INRSInstitut Armand-Frappier has just received ... in the amount of nearly US$600,000. The 5-year grant is ... called RNases and to explore their biomedical potential in the ... , "Receiving a grant at this level is ...
(Date:4/16/2014)... a densely packed array of finger-like projections called ... line our intestines., Vanderbilt University researchers have now discovered ... critical for absorbing nutrients and defending against pathogens. The ... , reveal a role for adhesion molecules in brush ...
Breaking Biology News(10 mins):Researchers: Obesity can amplify bone and muscle loss 2High-level NIH grant goes to professor Nicolas Doucet of INRS 2Vanderbilt researchers discover how intestinal cells build nutrient-absorbing surface 2Vanderbilt researchers discover how intestinal cells build nutrient-absorbing surface 3
... rodents known as Murinae (mice, rats, etc.), which first ... the entire Old World (Eurasia, Africa, Australia) in less ... have long suspected that one of the reasons for ... apparatus. Now, researchers have used the brilliant X-ray beams ...
... beginning of October. The goal is to develop the production ... manufacture tires made from dandelion rubber. This is why molecular ... supplier built a pilot facility in Mnster that is capable ... time, they cultivate several hectares of a dandelion variety which ...
... bus, escaping a burning building or taking part in ... up knee problems for later in life, according to ... Journal of Biomedical Engineering and Technology . 9 ... fatigue, numbness and bunions when wearing such footwear. Despite ...
Cached Biology News:Chewing their way to success 2Fraunhofer and Continental come together when the dandelion rubber meets the road 2Fraunhofer and Continental come together when the dandelion rubber meets the road 3No running for the well-heeled 2
... a high quality whole genome sequencing service. ... costs allow even the smallest of laboratories ... key features which set our whole genome ... construction strategies, proprietary assembly software, rapid project ...
Great for biotinylating DNA/RNA probes...
... polyclonal antibody to human XAB2 (amino terminus) ... identified through its interaction with XPA. Immunoprecipitation ... of XAB2 interacts with the transcription-coupled repair-specific ... with RNA polymerase II. Microinjection experiments with ...
... maintenance, calibration, and validation (MCV) ... 96-well plate used for hands-free ... procedures using the Bio-Plex suspension ... is for use with Bio-Plex ...
Biology Products: