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:7/26/2014)... Albany, NY (PRWEB) July 26, 2014 ... 2020 provides key market data on the Canada ... in millions of US dollars, volume (in units) ... segments - High-End Endoscopy Visualization Systems, Mid-Range Endoscopy ... Browse Full Report at http://www.marketresearchreports.biz/analysis/213254 . , ...
(Date:7/25/2014)... , July 25, 2014 Amgen (NASDAQ: ... today declared a $0.61 per share dividend for the ... on Sept. 5, 2014, to all stockholders of record ... 2014.  About Amgen Amgen is committed ... from serious illnesses by discovering, developing, manufacturing and delivering ...
(Date:7/25/2014)... researchers from the University of Leicester has furthered ... the potential to create new materials using nanosized ... published in the prestigious academic journal Physical ... to examine in rich detail the structure and ... an acetylene molecule and a single helium atom. ...
(Date:7/25/2014)... New York (PRWEB) July 25, 2014 ... Market Research, "Biological Drugs Market - Global Industry Analysis, ... the global biological drugs market is estimated at USD ... at a CAGR of 10.1% from 2014 to 2020, ... in 2020. , The biological drugs market is witnessing ...
Breaking Biology Technology:Canada Endoscopy Visualization Systems Market Outlook to 2020: MarketResearchReports.Biz 2Canada Endoscopy Visualization Systems Market Outlook to 2020: MarketResearchReports.Biz 3Canada Endoscopy Visualization Systems Market Outlook to 2020: MarketResearchReports.Biz 4Canada Endoscopy Visualization Systems Market Outlook to 2020: MarketResearchReports.Biz 5Amgen Announces 2014 Third Quarter Dividend 2Amgen Announces 2014 Third Quarter Dividend 3Breakthrough laser experiment reveals liquid-like motion of atoms in an ultra-cold cluster 2Breakthrough laser experiment reveals liquid-like motion of atoms in an ultra-cold cluster 3Biological Drugs Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Biological Drugs Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3
... - Gov Jim Doyle on Thursday announced that three ... from the Department of Commerce Technology Assistance Grant (TAG) ... are as follows: , , Functional Biosciences, ... to provide DNA sequencing. It will receive a $250,000 ...
... Thompson announced last week that he is planning to ... arm that will provide access to his electronic medical ... Alumni Research Foundation announced that it has licensed California ... cell patents. On another note, Madison biotech firm ...
... Alfalight, Inc. , a Madison-based manufacturer of high-power ... been awarded $1.4 million in funding for Phase II ... by the Defense Advanced Research Projects Agency. ... increase a laser's power conversion efficiency -- to lower ...
Cached Biology Technology:Alfalight garners $1.4 million defense funding for diode program 2
(Date:7/27/2014)... that wiped them out if it had taken place ... A fresh study using up-to-date fossil records and improved ... narrative of the prehistoric creatures, demise, some 66 million ... million years before a 10km-wide asteroid struck what is ... extensive volcanic activity, changing sea levels and varying temperatures. ...
(Date:7/27/2014)... studies have shown the potential for global climate change ... the most part, ignored the interactions between increasing temperature ... known to damage crops. , A new study involving ... quite significant, suggesting that policymakers need to take both ... security. , The study looked in detail at global ...
(Date:7/25/2014)... first broad-scale estimate of air pollution removal by trees ... trees are saving more than 850 human lives a ... , While trees, pollution removal equated to an average ... impacts of that improvement are substantial. Researchers valued the ... nearly $7 billion every year in a study published ...
Breaking Biology News(10 mins):Dinosaurs fell victim to perfect storm of events, study shows 2Study: Climate change and air pollution will combine to curb food supplies 2Study: Climate change and air pollution will combine to curb food supplies 3First national study finds trees saving lives, reducing respiratory problems 2
... microorganisms immediately after birth, and the microbiomes of their mouths ... day 15 according to a study published in mBio ... Microbiology. "We could watch this differentiation over time. ... gut] became more and more differentiated from each other. It ...
... Centuries of economic theory have been based on one simple ... the rational decision and select the one they value more. ... flaw in that it is demonstrably untrue. The fields ... list of common biases that cause people to act against ...
... our ancestors driven by the threat of snakes? Work by ... put forward by Lynne Isbell, professor of anthropology at the ... 28 in the journal Proceedings of the National Academy ... at Toyama University, Japan; and Rafael Maior and Carlos Tomaz ...
Cached Biology News:Microbiome in gut, mouth, and skin of low birth weight infants differentiate weeks after birth 2Microbiome in gut, mouth, and skin of low birth weight infants differentiate weeks after birth 3Common bias known as the 'endowment effect' not present in hunter-gatherer societies 2Common bias known as the 'endowment effect' not present in hunter-gatherer societies 3Common bias known as the 'endowment effect' not present in hunter-gatherer societies 4Snakes on the brain: Are primates hard-wired to see snakes? 2
Normal donkey serum collected from healthy normal donkeys....
Whole blood is collected from canines (any breed, either sex), refrigerated within 6 hours, processed within 24 hours and frozen at -20C....
... BAC (100+kb), fosmid (40kb), and large plasmid ... any othe BAC vector. On command 20-50 ... easy recombinant DNA purification. Available with blue-white ... vectors for the highest insert stability. Kits ...
Because it is manufactured at our ISO 9001–certified facilities in Eugene, Oregon, we can guarantee that FluoroPure grade propidium iodide is greater than or equal to 98% pure by HPLC....
Biology Products: