Navigation Links
Dendreon Receives FDA Acknowledgement of Complete Response
Date:11/20/2009

SEATTLE, Nov. 20 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

The FDA considers this to be a complete, Class 2 Resubmission following the action letter the company received in 2007. The BLA includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC. The resubmission also contains the remaining information requested by the FDA pertaining to chemistry, manufacturing and controls section of the BLA for PROVENGE.

If approved by the FDA, PROVENGE would represent the first product in a new therapeutic class known as active cellular immunotherapies.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple ty
'/>"/>

SOURCE Dendreon Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Dendreon Reports Third Quarter 2009 Financial Results and Continuing Progress Toward PROVENGE Commercialization
2. Dendreon Completes Submission of Biologics License Application for PROVENGE
3. Dendreon Announces Webcast Presentations at Upcoming Investor Conferences
4. Dendreon Announces Webcast Presentations at Upcoming Investor Conferences
5. Dendreon Announces Analyst Day Webcast Presentation to be Held on September 24, 2009
6. Dendreon Reports Second Quarter 2009 Financial Results
7. Dendreon Signs Lease for New Manufacturing Facility in Atlanta
8. Dendreon to Hold Conference Call on Tuesday, August 11, 2009 at 11:30 AM ET
9. Dendreon Announces Webcast Presentations at Upcoming Investor Conferences
10. Dendreon Corporation CEO Mitchell H. Gold, M.D. Named Ernst & Young Entrepreneur of the Year(R) 2009 Award Finalist in the Pacific Northwest
11. Dendreon Announces Closing of Common Stock Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... 14, 2014 Histogen, Inc., a regenerative ... cells grown under simulated embryonic conditions, today announced that ... Suneva Medical, Inc. for physician-dispensed aesthetic products containing Histogen’s ... This agreement is an amendment to the existing license ...
(Date:1/14/2014)... 2014 EquitiesIQ, a leading informational research ... Alliqua is an emerging biomedical company acquiring, developing, manufacturing, ... market. , Free report download: http://equitiesiq.com/reports/alliqua/ , ... management team and Board, which launched the company’s new ...
(Date:1/14/2014)... 2014 iLab Solutions, the leader in core ... Director of Product Strategy. In this role, Michelle will work ... to guide in the development of iLab products. Her main ... possible benefit to the scientific community by offering the most ...
(Date:1/14/2014)... 2014 Global Record Systems, LLC, ... technology solutions for patients, physicians, the biopharmaceutical industry, ... today the signing of a three-year Research Collaboration ... Administration (FDA). This initiative is designed to ...
Breaking Biology Technology:Histogen and Suneva Medical Expand License for Cell Conditioned Media-based Aesthetic Products Internationally 2Histogen and Suneva Medical Expand License for Cell Conditioned Media-based Aesthetic Products Internationally 3EquitiesIQ Initiates Coverage of Alliqua, Inc. 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 3iLab Solutions Announces Michelle Detwiler as the New Director of Product Strategy 2Global Record Systems Announces Research Collaboration Agreement with FDA to Create a Novel “Big Data” Paradigm for Collection of Patient Safety and Outcomes Information 2
... Institute, the leading provider of specialized training solutions ... subsidiary of Campbell Alliance, today announced the release ... Management Suite of e-courses.  The suite is ... account managers by addressing high-priority topics that drive ...
... from beneficial bacteria found in yogurt and dairy products ... bowel disorders (IBD), suggests a study led by Vanderbilt ... The study, published May 23 in the Journal ... p40, was effective as an intervention in animal models ...
... 2011The Annual Meeting of the American Crystallographic Association (ACA) ... in New Orleans, Louisiana. Crystallography is the science devoted ... solids and in complicated molecules. The study of biomolecules, ... important materials are often calculated by crystallographers using beams ...
Cached Biology Technology:Account Management Training Suite Delivers Two Key Performance Dimensions 2Protein from probiotic bacteria may alleviate inflammatory bowel disorders 2Protein from probiotic bacteria may alleviate inflammatory bowel disorders 3Sulfates in extreme places, DNA tied in knots and magnetic cooling at crystallography meeting 2Sulfates in extreme places, DNA tied in knots and magnetic cooling at crystallography meeting 3Sulfates in extreme places, DNA tied in knots and magnetic cooling at crystallography meeting 4
(Date:4/24/2014)... way of making a high-powered lens that can transform ... less than a cent, the lenses promise a revolution ... areas. , The lens fabrication technique was invented by ... Research School of Engineering, who collaborated with Dr Tri ... find ways to transform the lentil-sized lens into a ...
(Date:4/24/2014)... (LMU) in Munich have identified the structural features ... between viral and endogenous RNAs in living cells. ... of cellular metabolism and hijack cellular resources for ... dependent on viral RNA molecules that are delivered ... and/or newly synthesized in the host cell, and ...
(Date:4/24/2014)... new study representing the largest study of animal intelligence to-date ... better self-control. , Published this week in the journal ... is part of a long history of research aimed at ... to do things like make and use tools, read social ... , Until now, most studies of animal intelligence have focused ...
Breaking Biology News(10 mins):Droplet lens 2Viral infections: Identifying the tell-tale patterns 2Viral infections: Identifying the tell-tale patterns 3Animals with bigger brains, broader diets have better self control 2Animals with bigger brains, broader diets have better self control 3
... The Scripps Research Institute (TSRI) have found an easier way to ... new method allows scientists to add a marker to certain cells, ... from a larger cell population. The technique, which is ... Chemie International Edition , makes use of the tight binding of ...
... (RQR), Palais des congrs de Montral, Montral, Qubec, Canada, 22-26 ... 2013 -- The Society for the Study of Reproduction ... the 46th SSR Annual Meeting to be held in Montral, ... Meetings page ( http://www.ssr.org/Meetings.shtml ) for details; information will be ...
... New Rochelle, NY, January 8, 2013The world,s leading zebrafish ... promote science education. Scientific papers, many authored by students ... curricula and educational tools, a collection of abstracts (including ... from the recent Zebrafish in Education Workshops ...
Cached Biology News:Chemists devise inexpensive, benchtop method for marking and selecting cells 2Chemists devise inexpensive, benchtop method for marking and selecting cells 3Surprising teaching tool in K-12 science education -- Zebrafish research 2
Request Info...
Unit Definition: 1 U corresponds to the amount of enzyme which produces 1 mol protons per minute at pH 5.5 and 30C (peptin from citrus peel, Fluka-No. 76280, as substrate)...
... Pyruvate Kinase. This product ... kinase from other mammalian species but ... Specificity: Gives a single precipitin line ... Kinase.,Has been shown to react with ...
Rabbit polyclonal to Somatostatin 28 ( Abpromise for all tested applications). entrezGeneID: 6750 SwissProtID: P61278...
Biology Products: