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:10/19/2014)... The report "Unmanned Ground Vehicle ... Technology, Payload, Type & by Geography - Forecasts ... unmanned ground vehicle market into various sub segments ... sizes. The report also identifies the factors driving ... along with the adoption trends. , The unmanned ...
(Date:10/18/2014)... The “Human Insulin Market- by Product ... Modern Human Insulin (Rapid Acting, Long Acting, Premixed)], ... Others) - Forecast to 2018” provides a detailed ... current market trends, and strategies impacting the global ... forecasts of the revenue and share analysis. , ...
(Date:10/18/2014)... October 18, 2014 The report ... Trends and Forecasts to 2019", analyzes the global ... order to understand the industry details such as ... across various geographic regions. , Browse 81 Market ... Slides and in-depth TOC on “1,6-Hexanediol Market by ...
(Date:10/18/2014)... 2014 The Asia-Pacific hardware encryption display ... Asia-Pacific with analysis and forecast of revenue. This market ... to reach $51,362.6 million by 2018, at a CAGR ... the TOC of the Asia-Pacific hardware encryption market report, ... This also provides a glimpse of the segmentation of ...
Breaking Biology Technology:Unmanned Ground Vehicle (UGV) Market Estimated to Reach $8.26 Billion by 2020 - New Research Report by MarketsandMarkets 2Unmanned Ground Vehicle (UGV) Market Estimated to Reach $8.26 Billion by 2020 - New Research Report by MarketsandMarkets 3Unmanned Ground Vehicle (UGV) Market Estimated to Reach $8.26 Billion by 2020 - New Research Report by MarketsandMarkets 4Unmanned Ground Vehicle (UGV) Market Estimated to Reach $8.26 Billion by 2020 - New Research Report by MarketsandMarkets 5Medical Human Insulin Market Is Expected to Reach $42 billion by 2019 - New Research Report by MarketsandMarkets 2Medical Human Insulin Market Is Expected to Reach $42 billion by 2019 - New Research Report by MarketsandMarkets 3Medical Human Insulin Market Is Expected to Reach $42 billion by 2019 - New Research Report by MarketsandMarkets 4Medical Human Insulin Market Is Expected to Reach $42 billion by 2019 - New Research Report by MarketsandMarkets 51,6-Hexanediol Market Projected to Reach $916.1 Million at a CAGR of 8.3% by 2019 – Report by MarketsandMarkets 21,6-Hexanediol Market Projected to Reach $916.1 Million at a CAGR of 8.3% by 2019 – Report by MarketsandMarkets 31,6-Hexanediol Market Projected to Reach $916.1 Million at a CAGR of 8.3% by 2019 – Report by MarketsandMarkets 41,6-Hexanediol Market Projected to Reach $916.1 Million at a CAGR of 8.3% by 2019 – Report by MarketsandMarkets 5The Asia-Pacific hardware encryption display market is expected to reach $51,362.6 million by 2018 - New Report by MicroMarket Monitor 2The Asia-Pacific hardware encryption display market is expected to reach $51,362.6 million by 2018 - New Report by MicroMarket Monitor 3
... ... , ... August 13, 2009 -- Inc. magazine announced on Wednesday its 2009 Inc. 5000 ranking ... solutions company and a leader in web-database solutions, healthcare intelligence and specialized job boards, ...
... in Teddington have developed imaging technology to be used in ... an impending labour shortage for UK farmers. Annual waste ... can mean up to 100,000 of lost revenue for an ... during research. Falling number of migrant labourers means that healthy ...
... , , OMAHA, Neb., Aug. 12 Transgenomic, ... June 30, 2009. The Company,s financial results are presented in the tables that ... Company reported a net loss of $730,000 or $0.01 per share for the ... per share for the second quarter of 2008. , , ...
Cached Biology Technology:Massachusetts Technology Corporation Named to Inc. 5000 List of Fastest Growing Private Companies 2UK scientists developing intelligent harvesting robot to save farms up to 100,000 a year 2Transgenomic, Inc. Reports Second Quarter 2009 Results 2Transgenomic, Inc. Reports Second Quarter 2009 Results 3Transgenomic, Inc. Reports Second Quarter 2009 Results 4Transgenomic, Inc. Reports Second Quarter 2009 Results 5Transgenomic, Inc. Reports Second Quarter 2009 Results 6Transgenomic, Inc. Reports Second Quarter 2009 Results 7Transgenomic, Inc. Reports Second Quarter 2009 Results 8
(Date:10/15/2014)... VILNIUS, Lithuania , Oct. 15, 2014 /PRNewswire/ ... identification technologies, today announced the availability of the ... . VeriLook Surveillance 3.0 provides real-time biometric face ... multiple high-resolution digital surveillance cameras. The new version ... detects and differentiates people from objects while they ...
(Date:10/14/2014)... have sequenced the house fly genome for the first ... from an insect that thrives in pathogen-rich dung piles ... in the journal Genome Biology , will increase ... how flies quickly adapt to resist insecticides, which could ... (Musca domestica) carry and transmit more than 100 human ...
(Date:10/14/2014)... 2014 – Scientists from The Scripps Research Institute (TSRI) ... of Health (NIH) to lead an investigation of Lassa ... in Africa. The study aims to understand how Lassa ... while others survive the inflection. , "The ultimate ... of how Lassa fever virus causes disease and develop ...
Breaking Biology News(10 mins):VeriLook Surveillance 3.0 SDK Identifies Faces and Moving Objects, Differentiates Pedestrians from Other Moving Objects in Video Surveillance Systems 2VeriLook Surveillance 3.0 SDK Identifies Faces and Moving Objects, Differentiates Pedestrians from Other Moving Objects in Video Surveillance Systems 3House fly genome reveals expanded immune system 2Scripps Research Institute team receives $6.6 million to investigate deadly Lassa virus 2
... scientific detective story that uncovers a previously unrecognized ... of air pollutants. Incardona of the National ... from the U.S. government, Canadian government and academia ... Ocean Basins: Emerging Chemical Contaminants and Human Health. ...
... turtles ensnared in tuna nets are a heart-wrenching reminder ... in fisheries science as by-catch, this killing of non-target ... answers. One possible solution, advanced by NSERC grantee ... British Columbia involves digital maps and mathematical analysis to ...
... in the midst of a seething, breathing microbial world. ... from the surface of the human skin, to rainforest ... Despite the powerful and pervasive role of microbes ... a mystery. This is the subject of The Uncharted ...
Cached Biology News:New tool for resolving fisheries conflicts 2Unexplored microbes hold incredible potential for science and industry 2Unexplored microbes hold incredible potential for science and industry 3
... PureLink PCR Purification Kits provide rapid ... enzymes, short-failed PCR products, and salts from ... bind/wash/elute procedure:, provides two Binding Buffer ... bp* , can be performed in either ...
... Zero Blunt TOPO PCR ... fastest and easiest method ... or equal to95%) cloning ... amplified with proofreading thermostable ...
Quartz-Halogen, 100 W, High Intensity...
... System with Gateway™ Technology is designed ... the polyhedrin promoter. The expression cassette ... (bacmid DNA) by site-specific transposition (Tn7) ... recombinant bacmid DNA is then used ...
Biology Products: