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:12/19/2014)... 2014 BioPlus Specialty Pharmacy ... the promotion of Nick Maroulis, Pharm.D. to the newly ... , In this position, Dr. Maroulis will continue ... the directors of our multi-site pharmacies as the company ... and during that time he has served in many ...
(Date:12/19/2014)... , Dec. 19, 2014 Decision Resources ... will grow at a 12 percent compound annual growth ... of the aging population and the increasing adoption of ... America will also spur demand for dental ... dental implant and periodontal treatments. Other key ...
(Date:12/19/2014)... December 18, 2014 LayerBio is an ... and wound care. The National Eye Institute (NEI) at ... a Phase I SBIR grant to develop a drug-eluting ... the most common cause of vision loss in people ... worldwide. According to Dr. Ken Mandell, LayerBio’s Founder and ...
(Date:12/19/2014)... In contrast to traditional LED lights where the spectrum ... proprietary LED technology to incorporate their spectra in a ... critical in low proximity installations. The Valoya L-series offers ... which is up to four times longer than commonly ... was clearly higher when compared to traditional fluorescent or ...
Breaking Biology Technology:BioPlus Specialty Pharmacy Promotes Dr. Nick Maroulis to Vice President of Specialty Pharmacy Services 2Latin American Dental Biomaterial Market Will Expand at a 12 Percent Annual Growth Rate Through 2023 2Latin American Dental Biomaterial Market Will Expand at a 12 Percent Annual Growth Rate Through 2023 3LayerBio Awarded NIH Grant to Develop a Drug Delivery Device for Cataract Surgery 2
... who run St. Josephs Regional Medical Center here have a ... a walk-in clinic, an expensive practice that ties up valuable ... runny noses. To discourage people from using the ER for ... a $150 minimum fee. , ,The story is a symptom ...
... Wisconsin businesses have had to find new ways to compete. ... and most CEOs have taken a hard look at their ... attempting to be more effective, productive and competitive; all of ... shrinking market opportunity due to global competition and outsourcing! ...
... good one: pulling the states world-class health care technology ... well into the future. , ,The 20th Annual ... and Wednesday at Madisons Monona Terrace Convention Center, will ... the states burgeoning life sciences industry. The Wisconsin Technology ...
Cached Biology Technology:Health Care Reform is Working Its Way Back on to the Political Agenda 2Health Care Reform is Working Its Way Back on to the Political Agenda 3Technology Helps Our Economy to Survive and Grow 2Technology Helps Our Economy to Survive and Grow 3Conference Zeroes in on Homegrown Innovation - 20th Life Science & Venture Conference Full of High-Tech Insights 2
(Date:11/21/2014)... Calif. , Nov. 20, 2014   Atmel® ... leader in microcontroller (MCU) and touch technology solutions, today ... temperature sensors with the widest V cc ... higher temperature accuracy and faster I 2 C bus ... and serial EEPROM memory making them ideal for consumer, ...
(Date:11/18/2014)... -- The Parenteral Drug Association (PDA) today confirmed that seven ... at least seven more will participate in the upcoming 2014 ... in Washington D.C. , Dec. 2-4. ... from the regulatory agencies in the United States ... effort to help advance the use of metrics in the ...
(Date:11/12/2014)... , Nov. 12, 2014 Crossmatch™, a ... that its U.are.U ® fingerprint readers have been ... in Central Mexico . The bakery ... to eliminate payroll issues caused by employees clocking in ... the U.are.U fingerprint readers, Montparnasse relied on paper timecards ...
Breaking Biology News(10 mins):Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 2Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 3Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 4FDA's Janet Woodcock, EMA's Emer Cooke Headline PDA Quality Metrics Conference 2Montparnasse Pasteleria Achieves Time and Attendance Transparency with Crossmatch U.are.U Fingerprint Readers 2
... animal compares males to choose a mate, she can't order ... to rely on external cues that may indicate genetic quality. ... the peacock's tail, as cues that females might use. , ... between male genetic quality and ornament quality can be maintained. ...
... progenitor cells differentiate into cartilage cells when one master ... College of Medicine researchers in a report that appears ... of Sciences. , Skeletons are made of bone and ... stem cell, said Dr. Brendan Lee, associate professor of ...
... into brain cells on a new three-dimensional scaffold of ... living body than any other cell culture system. , ... invention-which may one day replace the ubiquitous Petri dish ... PLoS ONE. Shuguang Zhang, associate director of MIT's Center ...
Cached Biology News:Female pronghorns choose mate based on substance as well as show 2Signaling for cartilage 2MIT creates 3-D scaffold for growing stem cells 2MIT creates 3-D scaffold for growing stem cells 3
... functionally defined by their capacity to self ... multiple specialized progenitor cells, which can commit ... stem cells (NSCs) are capable of differentiating ... and oligodendrocytes. During the isolation and expansion ...
Anti Human JAM-1, Monoclonal Antibody, Clone M.Ab.F11...
Contained in EZ-Tn5™ Kits and are available separately for sequencing of an insertion site....
Request Info...
Biology Products: