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:8/29/2014)... are based on electrons, but one of the most ... i.e. circuits based on light (photons) instead of electrons. ... a stream of single photons and control their direction. ... attempts to achieve this control, but now scientists at ... steady stream of photons emitted one at a time ...
(Date:8/29/2014)... Pittsburgh, PA (PRWEB) August 29, 2014 ... Chairman, Hub MacDonald, and colleague Koichiro Matsuda, Horiba Scientific, ... JASIS on September 5, 2014. JASIS , Asia’s ... September 3-5, 2014, in Makuhari Messe, Japan. , ... New Tools for Bioanalysis from Single Molecules to Single ...
(Date:8/29/2014)... California (PRWEB) August 29, 2014 ... of Energy's 2014 Hydrogen Production R&D Award ... -- by splitting water using sunlight. , Shared ... (NREL) and the University of Nevada, Las Vegas ... work developing models of photoelectrochemical solar-hydrogen production and ...
(Date:8/29/2014)... August 29, 2014 Intrinsic Imaging, ... certified, GAMP® 5 compliant imaging core lab, announced ... Phase II clinical trial to assess a new ... this trial, Intrinsic Imaging will provide comprehensive imaging ... protocol and charter development, site qualification, site training ...
Breaking Biology Technology:Breakthrough in light sources for new quantum technology 2Fifth Annual U.S. Symposium at JASIS Organized by Pittcon’s Program Chairman Hub MacDonald 2Livermore Team Awarded for Hydrogen Production Research 2Intrinsic Imaging Awarded Phase II Clinical Trial to Assess New Treatment for Non-Hodgkin’s Lymphoma 2
... Consistent,Electronic Health Record for All Citizens Using City ... GREAT RIVER, N.Y., Oct. 16 Netsmart Technologies, ... for health and,human services organizations, today announced it ... contract by the City and County of San,Francisco, ...
... access to advanced gene-sequencing,technologies and gives new hope ... 16 Swedish Neuroscience,Institute (SNI) today announced that ... Hill Campus, the Center for Advanced Brain Tumor,Treatment ... patients diagnosed,with both benign and malignant brain tumors. ...
... Phase 3 CAPACITY Program - ... rate in CAPACITY -, BRISBANE, Calif., Oct. 16 ... 16, 2008, the Japanese,Ministry of Health, Labor and Welfare (MHLW) ... Ltd. to market pirfenidone,for the treatment of patients with idiopathic ...
Cached Biology Technology:Netsmart Technologies Selected by City and County of San Francisco to Provide Integrated Behavioral Healthcare Software System 2Netsmart Technologies Selected by City and County of San Francisco to Provide Integrated Behavioral Healthcare Software System 3Swedish in Seattle Unveils State-of-the-Art Brain Tumor Center Combining Advanced Treatment With Innovation in Research 2Swedish in Seattle Unveils State-of-the-Art Brain Tumor Center Combining Advanced Treatment With Innovation in Research 3Swedish in Seattle Unveils State-of-the-Art Brain Tumor Center Combining Advanced Treatment With Innovation in Research 4InterMune Reports Japanese Regulatory Approval of Pirfenidone in IPF 2InterMune Reports Japanese Regulatory Approval of Pirfenidone in IPF 3InterMune Reports Japanese Regulatory Approval of Pirfenidone in IPF 4
(Date:9/1/2014)... Mass-- Conventional wisdom has long held that corals ... coral reefs are passive organisms that rely ... such as nutrients and oxygen. But now scientists ... (WIS) in Israel have found that they are ... water into turbulent patterns that greatly enhance their ...
(Date:9/1/2014)... About 50 years ago, electron microscopy revealed the presence ... around and disappear. But scientists still don,t know what ... of proteins are believed to be crucial to the ... new approach to disease treatment., In the Journal ... call to investigators from various backgrounds, from biophysics to ...
(Date:8/31/2014)... A new blood test provides a fast and ... new proof-of-concept study shows. The newly developed test ... to detect active tuberculosis in children. The test ... tests in combination with speed of a blood ... for the diagnosis of tuberculosis in children, particularly ...
Breaking Biology News(10 mins):Nature's tiny engineers 2Nature's tiny engineers 3Scientists call for investigation of mysterious cloud-like collections in cells 2New tuberculosis blood test in children is reliable and highly specific 2
... German . , EASY-HIT** is a new cell-based ... This system was developed under the leadership of Professor Ruth ... the system are cultured human cells that allow HIV to ... producing a red fluorescent protein. The EASY-HIT technology can be ...
... Colo. (December 1, 2010) A major new study ... fetus to those smells and flavors, but physically changes the ... the future. "This highlights the importance of eating ... and nursing," said Josephine Todrank, PhD, who conducted the two-year ...
... from the UC Davis Health System have found that ... are significantly reduced in patients in the Sacramento area ... that affects about one in three U.S. adults and ... The study is the first to examine vitamin-D ...
Cached Biology News:A powerful new technology to identify HIV inhibitors 2Study shows pregnant mother's diet impacts infant's sense of smell 2Study finds low vitamin-d levels in northern California residents with metabolic syndrome 2Study finds low vitamin-d levels in northern California residents with metabolic syndrome 3Study finds low vitamin-d levels in northern California residents with metabolic syndrome 4
... cells for DNA isolation. Designed ... (includes 96 well plate adapters from ... the entire plate length (max capacity ... be used for soil, microorganisms, animal ...
Phospho- (Ser) 14-3-3 Binding Motif (4E2) Mouse mAb...
Rat polyclonal to acetyl Salicylic Acid ( Abpromise for all tested applications)....
Drugs and NO-drug Rat Anti-conjugated Acetyl Salicylic Acid Polyclonal Antibody...
Biology Products: