Navigation Links
Savient Provides Update on Meeting with U.S. Food and Drug Administration for KRYSTEXXA(TM)
Date:9/16/2009

EAST BRUNSWICK, N.J. Sept. 16 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that on September 14, 2009, the Company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) received by Savient on July 31, 2009 regarding the Company's Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy.

Based on the results of this meeting with the FDA, Savient believes that the FDA supports its approach to resolve all issues cited in the CRL. The meeting also confirmed that the FDA does not expect further clinical trials to be required as a result of Savient's reversion to the original manufacturing process to produce the Phase 3 clinical trial material for KRYSTEXXA, provided that no significant differences are observed between the material produced with the validated Phase 3 process and the Phase 3 clinical trial material. Savient, therefore, continues to believe that it can meet its previously discussed timeline of filing the resubmission in response to the CRL in early 2010.

"We are encouraged by the FDA's continuing collegial and collaborative dialogue in providing guidance to assist us in establishing the path forward to our resubmission for KRYSTEXXA," stated Paul Hamelin, President of Savient Pharmaceuticals. "We are grateful to the FDA for granting us this meeting so quickly and appreciate the considerable time and effort devoted by the FDA reviewers in evaluating our pre-meeting package and in providing very valuable feedback and guidance."

In response to the CRL, Savient requested and was granted the Type A meeting with the FDA to disc
'/>"/>

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

Page: 1 2 3 4 5 6

Related biology technology :

1. Savient Announces New Date for FDA Arthritis Advisory Panel Review of KRYSTEXXA(TM) for Treatment Failure Gout
2. Savient Pharmaceuticals Reports First Quarter 2009 Financial Results
3. Savient Pharmaceuticals to Raise $31 Million Through Registered Direct Offering
4. Savient Pharmaceuticals to Hold Fourth Quarter and Year-End 2008 Results Conference Call on Thursday, February 26, 2009
5. Savient Announces Appointment of David Gionco as Chief Financial Officer
6. Savient Pharmaceuticals to Present at the Lazard Capital Markets 5th Annual Healthcare Conference on November 18th
7. Savient Pharmaceuticals Reports Third Quarter 2008 Financial Results
8. Savient Submits Biologics License Application (BLA) for pegloticase
9. Savients Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
10. Savient Pharmaceuticals to Hold Third Quarter 2008 Financial Results Conference Call on Thursday, November 6, 2008
11. Access Pharmaceuticals Provides Update on ProLindac(TM)Clinical Development Plan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... July 10, 2014 EvoDerma ’s NOOME ... This rejuvenating device now comes with a second treatment cup ... time. , The new cup is thinner on the edges ... to target rough, thin and uneven surfaces on the face, ... for a stimulating treatment on areas such as the cheeks ...
(Date:7/10/2014)... 10, 2014  Franciscan St. Anthony Health-Crown ... for respiratory monitoring outside the operating room, ... in embracing state-of-the-art patient safety technology. ... breathing and can alert medical caregivers when ... amount of carbon dioxide the patient is ...
(Date:7/10/2014)... 10, 2014  Kainos Capital, a firm specializing in ... that it has acquired the Slim-Fast brand from Unilever. ... Terms of the transaction were not disclosed. ... business that markets ready-to-drink shakes, powders, bars and snacks ... and in the United Kingdom ...
(Date:7/10/2014)... 10, 2014 Research and Markets ( ... "International Photonic Integrated Circuit (Monolithic Integration, Hybrid ... report to their offering. ... of photonic integration traces its roots in the ... of photonic integration went unexplored and unfulfilled for ...
Breaking Biology Technology:Introducing a New Bonus Treatment Cup for EvoDerma’s NOOME Anti-Aging Motion 2Franciscan St. Anthony Health-Crown Point Underscores Patient Safety Commitment Through Expanded Use of Capnography 2Kainos Capital Acquires Slim-Fast From Unilever 2International Photonic Integrated Circuit (Monolithic Integration, Hybrid Integration, Module Integration) Market - Forecasts to 2019 2
... 2003 , , MADISON, Wis. -- Forty-five ... the 2004 Technology Awards Banquet for receiving over $24.6 ... held in conjunction with the Wisconsin Entrepreneurs? Conference ... small business innovation research (SBIR) and advanced technology program ...
... MILWAUKEE Despite the encroachment of wireless technology, broadband ... popular with business and home users, according to Dan ... Warner Cable . , ,In his keynote address Wednesday ... what he sees as the future of broadband, mentioning ...
... has published the first-ever magazine about Wisconsins life ... research base, technology-transfer process, company creation, quality of ... joins Chicago, Wisconsin and Minneapolis-St. Paul. , ,The ... from Life Sciences: Wisconsin The Smart Choice, ...
Cached Biology Technology:Wisconsin technology companies awarded over $24 million in government funding 2Wisconsin technology companies awarded over $24 million in government funding 3Wisconsin technology companies awarded over $24 million in government funding 4Future of cable, wireless shown off at ITEC Milwaukee 2Future of cable, wireless shown off at ITEC Milwaukee 3Future of cable, wireless shown off at ITEC Milwaukee 4Life Sciences: Wisconsin- The Smart Choice 2Life Sciences: Wisconsin- The Smart Choice 3Life Sciences: Wisconsin- The Smart Choice 4Life Sciences: Wisconsin- The Smart Choice 5Life Sciences: Wisconsin- The Smart Choice 6Life Sciences: Wisconsin- The Smart Choice 7
(Date:7/11/2014)... study the proteins that let nerve cells send out ... upon a biological tactic that may offer a new ... safe and environmentally responsible way. , Their findingthat ... species and harmless for a closely related onesuggests that ... harming beneficial species like bees. A summary of the ...
(Date:7/10/2014)... Albuquerque, and other major cities in New Mexico, nearly ... municipal wastewater rather than precious potable water supplies. Across ... of all golf courses receive treated effluent. Reusing the ... Additionally, golf courses and homeowners alike fertilize their lawns ... is nitrate. A New Mexico State University turfgrass expert ...
(Date:7/10/2014)...  Pomerantz LLP has filed a class action ... "Company")(NYSE-MKT: PVCT) and certain of its officers.  The ... Middle District of Tennessee , ... consisting of all persons or entities who purchased ... 2013 and May 22, 2014, both dates inclusive ...
Breaking Biology News(10 mins):Potent spider toxin 'electrocutes' German, not American, cockroaches 2Potent spider toxin 'electrocutes' German, not American, cockroaches 3'Tailored' water -- the latest in lawn care 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against Provectus Biopharmaceuticals, Inc. and Certain Officers - PVCT 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against Provectus Biopharmaceuticals, Inc. and Certain Officers - PVCT 3
... April issue of the Journal of the American ... eating plans; dietary quality among children; and relationships between ... Increased Risk of Eating Disorders , While vegetarians tend ... non-vegetarians to be overweight or obese, they may be ...
... the Richard King Trainee Award. This award was instituted last ... to encourage ABMG trainees in their careers and to foster ... year the editorial board will review all articles published in ... or corresponding author during that year. The manuscript felt to ...
... Being able to accurately predict how a given ... non-responsive tumors the burden of undergoing toxic and ultimately ... a patient,s cancer-causing genetic lesions are contributing to drug ... Researchers led by Professor Scott Lowe, Ph.D., ...
Cached Biology News:News from the April 2009 Journal of the American Dietetic Association 2Jonathan Berg, M.D., Ph.D. awarded Richard King Trainee Award for Best in Genetics in Medicine 2CSHL team develops mouse models of leukemia that predict response to chemotherapy 2CSHL team develops mouse models of leukemia that predict response to chemotherapy 3CSHL team develops mouse models of leukemia that predict response to chemotherapy 4
... workstation is the simplest, easiest-to-use system ever ... liquid handling capabilities,into their labs, or groups ... routine applications on a separate instrument. Plate-handling ... even when you have thousands of ...
... has generated hybridomas against a large ... initiation, you are provided with personalized ... cell lines developed by Covance remain ... typical hybridoma development project has four ...
... cDNA normalization is essential for ... using high-throughput approaches, such as EST ... Most normalization methods are not well ... cDNA. The Evrogen TRIMMER kit, though, ...
... ENGENISTM (Entire Gene/cDNA or Isolated Sequence) siRNA ... quantitative approach for evaluation of a potential ... an efficient target for RNA interference (RNAi). ... not perfect, leaving the probability of selected ...
Biology Products: