Navigation Links
FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months
Date:8/8/2008

HORSHAM, Pa., Aug. 8 /PRNewswire/ -- Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by three months to December 2008. The application, filed by Centocor late in 2007, seeks approval to market ustekinumab for the treatment of adult patients with chronic moderate to severe plaque psoriasis.

The FDA extended the review period to provide additional time for review of amendments to the application provided by Centocor within the last three months. The FDA has requested no additional clinical trials.

On June 17, 2008, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously recommended ustekinumab for approval. DODAC is convened on request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of dermatologic and ophthalmologic conditions. The committee provides non-binding recommendations based on its evaluation; however, the FDA makes the final decision on approval of the drug. Ustekinumab is also under review by the European Medicines Agency (EMEA).

About Psoriasis

Psoriasis is a chronic, immune-mediated disease, which results from the overproduction of skin cells, resulting in their accumulation on the surface of the skin, which causes red, scaly plaques that may itch and bleed. It is estimated that approximately 7.5 million people in the United States and 10 million Europeans are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.

About Ustekinumab

Ustekinumab is a new, human monoclonal antibody in Phase 3 development by Centocor, Inc. for the treatment of moderate to severe plaque psoriasis, and is being investigated as an infrequently administered subcutaneous injection. Ustekinumab is a novel biologic therapy that targets interle
'/>"/>

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

Page: 1 2

Related biology technology :

1. Roche Extends Tender Offer for Ventana
2. MichBio Announces Expo Tours; Extends Deadline for Innovator Showcase Applications
3. NASA Extends Cooperative Agreement With NSBRI
4. Organon Extends MetaCore License and Adds MetaLink
5. NPS Pharmaceuticals, Inc. Announces an Increase in Tender Offer Price for Its 3.0% Convertible Notes Due 2008 and Extends Expiration Date Until October 17, 2007
6. Roche Extends Tender Offer for Ventana
7. GSK Extends GeneGo License and Adds New Products
8. Netsmart Technologies Extends Relationship with Manatee Glens for Enterprise Behavioral Health Software Solutions
9. Evotec Extends Ongoing Collaboration With CHDI Worth up to US$ 37 Million
10. Actavis Receives Approval for Irinotecan Hydrochloride Injection; Extends US Portfolio with First Injectable Product
11. Ingenuity Systems Extends Enterprise-Level Software Agreement With GlaxoSmithKline
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/27/2014)... 27, 2014 Ryan Carfley , Managing ... to sit down with Bryan Hamilton, the publisher of the ... discuss talent in the Research Triangle region of North Carolina. ... highlighted at the roundtable include the role of social ... of work/life balance and the unique role that Millennials play ...
(Date:10/27/2014)... -- The Italian company Roadrunnerfoot has ... its artificial "lower limb", after the German giant ...      (Photo: http://photos.prnewswire.com/prnh/20141027/713097 ) , ... judgement has arrived: Roadrunnerfoot, the small Italian company ... prostheses with composite materials, has won against global ...
(Date:10/27/2014)... , Oct. 27, 2014 Kalorama Information says ... Ebola concern in the United States ... The healthcare market researcher said the FDA,s Emergency Use Authorization ... diagnostic tests for the detection of the Ebola virus ... useful.  Kalorama routinely assess the IVD industry and its ...
(Date:10/27/2014)... MA (PRWEB) October 27, 2014 ... profit. SoundConnect , an industry leading unified ... its partners and agents to deliver cloud-based audio ... accelerate growth opportunities. , With SoundConnect’s Q4 ... every twenty-five video and/or web conferencing licenses sold, ...
Breaking Biology Technology:Personify's Ryan Carfley Talks Recruiting with Triangle Business Journal, RPG Solutions 2Personify's Ryan Carfley Talks Recruiting with Triangle Business Journal, RPG Solutions 3Italian Lower Limb Prosthesis Company Wins Lawsuit Against German Giant Ottobock 2Kalorama: PCR The Go-to Test in Ebola Fight 2Kalorama: PCR The Go-to Test in Ebola Fight 3SoundConnect Unveils Q4 Partner Incentives 2
... 2011 NewCardio, Inc., (OTC BB: NWCI) a cardiovascular ... Clinilabs, will utilize QTinno®, NewCardio,s automated cardiac safety solution, ... new drug under development for a central nervous system ... one important aspect of the trial. Clinilabs, ...
... a biotechnology company developing peptide therapeutics for metabolic diseases, ... as Chief Executive Officer. Dr. Gottesdiener joins Rhythm from ... President and Late-Stage Therapeutic Group Leader, with responsibility for ... and previously as head of early-stage clinical development programs. ...
... -- an open-source, web-based platform for data-intensive biomedical ... a "cloud computing" resource. A team of researchers ... and molecular biology at Penn State University; Kateryna ... State; and James Taylor from Emory University, developed ...
Cached Biology Technology:Clinilabs will Conduct Phase 1 Trial Using QTinno® 2Clinilabs will Conduct Phase 1 Trial Using QTinno® 3Clinilabs will Conduct Phase 1 Trial Using QTinno® 4Clinilabs will Conduct Phase 1 Trial Using QTinno® 5Rhythm Names Keith M. Gottesdiener Chief Executive Officer 2Galaxy DNA-analysis software is now available 'in the cloud' 2Galaxy DNA-analysis software is now available 'in the cloud' 3
(Date:10/29/2014)... York City on September 19, 2014, leading geneticist and ... of Genome Sciences and Medicine at the University of ... of Tel Aviv University, was awarded the 2014 Lasker-Koshland ... to her honorary degree from TAU, Prof. King was ... Medicine, and for the past 18 years she has ...
(Date:10/29/2014)... Cambridge, MA and Hebei, China — BGI Tech and ... sequencing of the Jujube genome. Jujube is the most ... Jujube genome is particularly difficult to sequence due the ... is the first time that a genome in the ... been recently published in Nature Communications ...
(Date:10/28/2014)... One of the tragic realities of cancer is ... highly toxic and their effectiveness varies unpredictably from ... is poised to change this reality by rapidly ... on an individual,s cancer before chemotherapy begins. , ... headed by Assistant Professor Melissa Skala has developed ...
Breaking Biology News(10 mins):Geneticist and humanitarian: Prof. Mary-Claire King receives Lasker Award 2BGI Tech and Hebei Agricultural University complete the genome sequencing of the jujube tree 2Improving breast cancer chemo by testing patient's tumors in a dish 2Improving breast cancer chemo by testing patient's tumors in a dish 3
... of the embryo in the uterus have found a ... vessels that sustain the embryo. Without this protein, which is ... embryo is unlikely to survive. This is the first ... estrogen spurs cell differentiation and blood-vessel growth in the uterus ...
... techniques are increasing hope of restoring fertility for women ... destruction of reproductive tissue. The same techniques can also ... protect against extinction of endangered animal species by maintaining ... can used to produce offspring at some point in ...
... percent of fish species in North American streams, rivers ... most detailed evaluation of the conservation status of freshwater ... 700 fishes now listed represent a staggering 92 percent ... previous 1989 study published by the American Fisheries Society. ...
Cached Biology News:Gap junction protein vital to successful pregnancy, researchers find 2Cryopreservation techniques bring hopes for women cancer victims and endangered species 2Silent streams? Escalating endangerment for North American freshwater fish 2Silent streams? Escalating endangerment for North American freshwater fish 3