Navigation Links
FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for KRYSTEXXA(TM) for Refractory Chronic Gout
Date:6/16/2009

Savient to Host Conference Call and Webcast on Wednesday, June 17 at 8:30 a.m. Eastern Time

EAST BRUNSWICK, N.J., June 16 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced today that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended by a vote of 14 to 1 that KRYSTEXXA(TM) (pegloticase), a biologic PEGylated uricase enzyme, be granted marketing approval by the FDA for the treatment of refractory chronic gout. Refractory chronic gout or treatment failure gout (TFG) is gout in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with conventional urate-lowering therapy at the maximum medically appropriate dose or for whom conventional urate-lowering therapy is contraindicated. The current target Prescription Drug User Fee (PDUFA) action date for the FDA's decision as to whether to grant marketing approval for KRYSTEXXA is August 1, 2009.

"We are very pleased with the Advisory Committee's recommendation, which supports our belief that KRYSTEXXA has a favorable risk to benefit profile in patients suffering from TFG," said Paul Hamelin, President of Savient Pharmaceuticals, Inc. "KRYSTEXXA has the potential to provide an important new treatment option for patients with TFG, who currently have no other available treatment options, and many of whom suffer from serious pain and disability."

The Advisory Committee's recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application that Savient has submitted for KRYSTEXXA.

Conference Call Information

Savient will host a live webcast to discuss the results from the FDA Advisory Committee meeting on June 17, 2009 at 8:30 a.m. Eastern Time.
'/>"/>

SOURCE Savient Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Santaris Pharma Director Appointed Adjunct Professor in RNA Biology at the University of Aalborg, Denmark
2. Former GE Healthcare Director, Per Foss Appointed CEO for HUNT Biosciences
3. Paul Keim Appointed to febits Scientific Advisory Board
4. Andrew Chisholm Appointed Vice President, Sales and Corporate Accounts at Accumetrics
5. Timothy I. Still Appointed CEO at Accumetrics
6. Robert Cantu Appointed Vice President of Pierpoint International
7. Nader Naeymi-Rad Appointed Chief Operating Officer at Campbell Alliance
8. Darius Naigamwalla Appointed Senior Vice President and Head of the Brand Management Practice at Campbell Alliance
9. Dr. Robert N. Butler Appointed to Board of Directors of BioTime, Inc.
10. William P. Sheridan Appointed Chief Medical Officer of BioCryst Pharmaceuticals
11. Lillys Connelly Appointed to the Presidents Commission on White House Fellowships
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... 2014 Earlier this year in a ... director of the Adult Stem Cell Technology Center, LLC ... and under appreciated unique property of adult tissue stem ... Cells: Misunderstood in the Past, Important for the Future,” ... He gave the address at the 4th World ...
(Date:12/24/2014)... Island, New York (PRWEB) December 23, 2014 ... and the Long Island Affiliate of ITRA Global, the national ... slow but steady recovery. This is evidenced by the ... the strong stock market. Low energy costs have held ... The only negative is the housing market remaining soft. ...
(Date:12/24/2014)... The report expects global cell isolation and ... also provides a carefully analyzed data about the vital ... market. , Full Copy of Report @ http://bit.ly/1yUxy0T ... for cell expansion will keep witnessing growth at an ... to be driven by rapid technological advancements, government funding ...
(Date:12/24/2014)... AUSTIN, Texas , Dec. 23, 2014 /PRNewswire/ ... solutions company focused on gynecologic disease, announced today ... W. Schuler , Birchview Fund LLC and several ... million of unregistered shares of Vermillion,s common stock ... common stock in a private placement.  ...
Breaking Biology Technology:Adult Stem Cell Technology Center, LLC’s Director Sherley's Address on What’s Holding Back Regenerative Medicine Featured on Omics Group Website 2Adult Stem Cell Technology Center, LLC’s Director Sherley's Address on What’s Holding Back Regenerative Medicine Featured on Omics Group Website 3Adult Stem Cell Technology Center, LLC’s Director Sherley's Address on What’s Holding Back Regenerative Medicine Featured on Omics Group Website 4ITRA Global Reports Long Island Is Out of Sync With The National Office Market 2ITRA Global Reports Long Island Is Out of Sync With The National Office Market 3The Cell Expansion Market is Expected to Reach $14.8 billion by 2019 - New Research Report by MarketsandMarkets 2The Cell Expansion Market is Expected to Reach $14.8 billion by 2019 - New Research Report by MarketsandMarkets 3Vermillion Announces Equity Financing of up to $18.9 Million; Suspends ATM Program 2Vermillion Announces Equity Financing of up to $18.9 Million; Suspends ATM Program 3Vermillion Announces Equity Financing of up to $18.9 Million; Suspends ATM Program 4Vermillion Announces Equity Financing of up to $18.9 Million; Suspends ATM Program 5
... the first self-powered nano-device that can transmit data wirelessly ... Nano Letters , they say it proves the ... sensors, airborne and stationary surveillance cameras and sensors, wearable ... batteries on energy collected from the environment. ...
... 2011 Solid grounding in science is widely considered ... leaders. From biochemists and pharmacists to physician assistants and ... market lies in the fields of healthcare and science. ... conducted by Harris Interactive for University of the ...
... Synthetic Genomics, Inc. (SGI), a privately held company applying ... including clean renewable energy, new food sources, and medicines, ... as Chief Financial Officer (CFO), effective June 18, 2011. ... financial aspect of the company. He will report directly ...
Cached Biology Technology:Careers in Healthcare and Science? "Not Interested" Say Half of U.S. Teens 2Careers in Healthcare and Science? "Not Interested" Say Half of U.S. Teens 3Careers in Healthcare and Science? "Not Interested" Say Half of U.S. Teens 4Synthetic Genomics Inc. Appoints Joseph Mahler as Chief Financial Officer 2
(Date:12/11/2014)... --Research and Markets , ... ) has announced the addition of the ... to their offering. One major ... technology. With continuous advances in technology, it is ... standard that meets the needs and expectations of ...
(Date:12/10/2014)... N.C. , Dec. 9, 2014  Valencell, a ... it is seeing a staggering demand from its licensees ... the Company revealed, is not solely coming from fitness ... as well. "A wearable is only as ... result, accuracy is the ultimate driver in long-term mass ...
(Date:12/5/2014)... 4, 2014 Increased emphasis on product ... new testing and inspection technologies. The convergence of ... a range of innovative test solutions. This trend ... Y, which is generally more inclined towards communication, ... development strategies of test equipment vendors will cater ...
Breaking Biology News(10 mins):Biometrics Market in the APAC Region 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2Wearable Technology Products Demand Highly Accurate Biometric Technology 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 3Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 4
... time to economically value the greenhouse gas-trapping potential of mine ... and geologist Michael Hitch of the University of British Columbia ... for its CO 2 -sequestration potential, or "SP." He says ... offset CO 2 emissions with so-named "SP rock," and ...
... The human nose has millions of olfactory neurons grouped into ... expresses only one odorant receptor, and all neurons expressing the ... an organization that allows for specific odors to be sensed. ... neurons that express a specific odor receptor that detects a ...
... that exposes approximately half of the world,s population to the ... disease. In a study published in the latest issue of ... and his team at Instituto Gulbenkian de ... forms of malaria can be prevented by a simple mechanism ...
Cached Biology News:Researchers tap into CO2 storage potential of mine waste 2Researchers tap into CO2 storage potential of mine waste 3How cells in the nose detect odors 2How cells in the nose detect odors 3Tolerance to malaria by means of iron control 2
... Analysis Note: The kit contains all ... convenient determination of NADPH-cytochrome c reductase activity ... purified microsomes [endoplastic reticulum (ER)]. It has ... tissues such as liver, kidney, brain, spleen, ...
... CHEMICON's Cell Transformation Detection Assay is an ... is considered the most stringent assay for ... this assay, cells (pre-treated with carcinogens or ... in soft agar medium for 21-28 days. ...
... The EZ DNA Methylation Kit uses a ... for DNA methylation analysis. The kit is ... takes place between cytosine and sodium bisulfite ... EZ DNA Methylation Kits innovative in-column desulphonation ...
... Select Tissue Arrays are intended for laboratory ... were fixed in neutral buffered formalin and ... diagnosis was performed by certified pathologists. ... blocks and relocated into a new recipient ...
Biology Products: