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:7/25/2015)... , ... July 25, 2015 , ... ... its refractometer series. It precisely checks and adjusts the surface temperature of the ... , In the pharmaceutical industry, data traceability and documentation are key requirements. It ...
(Date:7/24/2015)... 2015 Equity Research Institute has ... (NASDAQ: PDLI ), Arena Pharmaceuticals Inc. (NASDAQ: ... Biotherapeutics Inc. (NASDAQ: NWBO ), and Acorda Therapeutics ... PDL BioPharma can be accessed at https://www.EquityResearchInstitute.com/reports?keyword=PDLI ... at 5,146.41, down 0.49%, the Dow Jones Industrial Average ...
(Date:7/24/2015)... BEIJING , July 24, 2015 Origin Agritech ... supplier of crop seeds in China , ... third quarter fiscal year 2015 ended June 30, 2015, before ... The Company will host a teleconference on August 5th, 2015, ... time to discuss the results. To participate in ...
(Date:7/24/2015)... , ... July 24, 2015 ... ... class-leading frozen sample management solution, indispensable to any modern scientific or pharmaceutical ... has a user-friendly interface. Users know precisely where a sample is located ...
Breaking Biology Technology:It’s T-Time for Refractometers: On-site Temperature Check Now Available 2Biotechnology Stocks in Motion -- PDL BioPharma, Arena Pharma, StemCells, Northwest Biotherapeutics, and Acorda Therapeutics 2Biotechnology Stocks in Motion -- PDL BioPharma, Arena Pharma, StemCells, Northwest Biotherapeutics, and Acorda Therapeutics 3Biotechnology Stocks in Motion -- PDL BioPharma, Arena Pharma, StemCells, Northwest Biotherapeutics, and Acorda Therapeutics 4Biotechnology Stocks in Motion -- PDL BioPharma, Arena Pharma, StemCells, Northwest Biotherapeutics, and Acorda Therapeutics 5Origin Agritech Limited to Announce Third Quarter Fiscal 2015 Unaudited Financial Results on August 5th, 2015 2Origin Agritech Limited to Announce Third Quarter Fiscal 2015 Unaudited Financial Results on August 5th, 2015 3RURO, Inc. Partners with Integrated Systems Engineering to Provide Comprehensive LIMS Software to Biobanks 2RURO, Inc. Partners with Integrated Systems Engineering to Provide Comprehensive LIMS Software to Biobanks 3RURO, Inc. Partners with Integrated Systems Engineering to Provide Comprehensive LIMS Software to Biobanks 4
... MILFORD, Mass., May 12, 2011 SeraCare Life Sciences, ... sciences company providing vital products and services to facilitate ... therapeutics, today reported operational and financial results for its ... 2011. (Logo: http://photos.prnewswire.com/prnh/20110324/NE70714LOGO) "In the ...
... 12, 2011 Reportlinker.com announces that a new ... Industrial Biotechnology China News 1104 ... Influenced by the regional turbulence in Egypt and ... record high at USD102 per barrel on March ...
... 11, 2011 Nile Therapeutics, Inc. (NASDAQ: ... for heart failure patients, today announced that the Company,s securities ... the open of business on May 12, 2011.  The Company ... symbol on the OTCQB Marketplace following the suspension of trading ...
Cached Biology Technology:SeraCare Reports Second Quarter Fiscal Year 2011 Financial Results 2SeraCare Reports Second Quarter Fiscal Year 2011 Financial Results 3SeraCare Reports Second Quarter Fiscal Year 2011 Financial Results 4SeraCare Reports Second Quarter Fiscal Year 2011 Financial Results 5SeraCare Reports Second Quarter Fiscal Year 2011 Financial Results 6Reportlinker Adds Industrial Biotechnology China News 1104 2Reportlinker Adds Industrial Biotechnology China News 1104 3Nile Therapeutics to Transition to OTCQB Marketplace 2Nile Therapeutics to Transition to OTCQB Marketplace 3
(Date:7/9/2015)... JOSE, Calif. , July 9, 2015 ... the leading developer of human interface solutions, ... technology, the industry,s first fully hardware encapsulated ... Match-in-Sensor secure authentication technology is literally off ... storage and biometric matching within the fingerprint ...
(Date:7/8/2015)... , N.J. and NEW YORK , July ... Guidepoint today announced BD & Guidepoint ... companies with free access to Guidepoint,s expert network services. ... that are developing cutting-edge technologies to improve healthcare delivery ... Guidepoint research manager, each start-up entrepreneur will be able ...
(Date:7/8/2015)... The consumer products industry for innovative ... products such as wearables, smart wallets & other smart technology ... devices continues to rapidly grow.  Biometrics & Wearable Device Companies ... Google Inc. (NASDAQ: GOOG ), Apple Inc. (NASDAQ: ... (NASDAQ: GPRO ) and Baidu Inc. (NASDAQ: BIDU ...
Breaking Biology News(10 mins):Synaptics Announces World's First Match-in-Sensor Fingerprint Authentication Technology 2Synaptics Announces World's First Match-in-Sensor Fingerprint Authentication Technology 3BD and Guidepoint Team to Connect Healthcare Start-up Companies With Business and Scientific Experts 2BD and Guidepoint Team to Connect Healthcare Start-up Companies With Business and Scientific Experts 3Consumers Flock to This Summer's Must Have Tech Gadgets as Latest Digital Wallets, Smart Technology & Wearable Products Continue to Grow in Popularity & Functionality 2Consumers Flock to This Summer's Must Have Tech Gadgets as Latest Digital Wallets, Smart Technology & Wearable Products Continue to Grow in Popularity & Functionality 3Consumers Flock to This Summer's Must Have Tech Gadgets as Latest Digital Wallets, Smart Technology & Wearable Products Continue to Grow in Popularity & Functionality 4Consumers Flock to This Summer's Must Have Tech Gadgets as Latest Digital Wallets, Smart Technology & Wearable Products Continue to Grow in Popularity & Functionality 5Consumers Flock to This Summer's Must Have Tech Gadgets as Latest Digital Wallets, Smart Technology & Wearable Products Continue to Grow in Popularity & Functionality 6
... led by a Texas A&M University professor have discovered ... more than 4,200 years old, making them among the ... by Brendan Roark of Texas A&M,s College of Geosciences, ... Australian National University in Canberra, have had their work ...
... the National Institute of Standards and Technology (NIST) and ... detect and monitor the tiny amount of light reflected ... microscope probe, and in so doing has demonstrated a ... under ambient conditions. Their recently reported work* potentially affects ...
... bacteria have learned to manipulate the proportion of females ... have mapped the entire genome of a bacterium that ... findings, published in PNAS, reveal extremely high frequencies of ... future it is hoped that it will be possible ...
Cached Biology News:4,000-year-old coral beds among world's oldest living things, prof says 2Making a point: Picoscale stability in a room-temperature AFM 2Gene exchange common among sex-manipulating bacteria 2
mCD-1 10 transcription reactions...
Recombinant Rhesus Macaque IFN-alpha...
... 500 g protein ... mouse whole cell lysate; Abelson transformed ... provided as Western blotting positive control, ... freezing and thawing should be minimized, ...
The epitope is specific for TASK and is not present in any other known proteins tested so far.,SPECIES REACTIVITIES: The epitope is also highly conserved between mouse and rat (17/18 residues iden...
Biology Products: