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:5/4/2015)... Achieved primarily through a proprietary paraffin and stain additive, ... better detail than the industry standard. But because ... methods, it needed another medium to measure its detail. ... reference because it represents the highest standard of detail ... discovery days of Ultralight Histology was to reverse engineer ...
(Date:5/4/2015)... May 4, 2015   Tocagen Inc. , ... data from Tocagen,s ongoing investigational studies were presented ... the American Association of Neurological Surgeons (AANS)/Congress of ... 1-2, 2015, in Washington, D.C. ... a meeting with FDA and continues to advance ...
(Date:5/1/2015)...  Northwest Biotherapeutics (NASDAQ: NWBO ) ("NW Bio"), ... for solid tumor cancers, announced today that the Company ... a $40 million investment from Woodford investment funds in ... million in NW Bio on November 19, 2014.  On ... the Company for a further $40 million investment in ...
(Date:5/1/2015)... /CNW/ - Softchoice, a leading North American IT solutions and managed ... of two Cisco® Partner Summit Country awards. ... Security Partner of the Year for Canada ... in Montreal . "We ... awards at this year,s conference," said David MacDonald , ...
Breaking Biology Technology:Tocagen Presents Updated Interim Survival Data from Ongoing Clinical Studies at American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Section on Tumors 2Tocagen Presents Updated Interim Survival Data from Ongoing Clinical Studies at American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Section on Tumors 3Tocagen Presents Updated Interim Survival Data from Ongoing Clinical Studies at American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Section on Tumors 4Tocagen Presents Updated Interim Survival Data from Ongoing Clinical Studies at American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Section on Tumors 5NW Bio Closes On $28.5 Million Second Tranche Of Woodford $40 Million Financing 2NW Bio Closes On $28.5 Million Second Tranche Of Woodford $40 Million Financing 3Softchoice recognized with two Country Awards at Cisco Partner Summit 2015 2
... - GeneNews Limited (TSX: GEN), a company ... the early detection of diseases and personalized ... Laboratories, leading providers of laboratory services, information ... specimen collection services for ColonSentry(TM), the world,s ...
... November 20 ,Debiopharm Group (Debiopharm), a ... serious medical conditions and particularly,oncology, and ... fully integrated, global biotech focused on ... development from target identification and,validation to ...
... Discovery S.A., a Swiss biotech firm and Laborium Biopharma, a subsidiary ... development and optimization of protein bioprocess production and scale-up. , ... ... S.A., a Swiss biotech firm and Laborium Biopharma, a subsidiary of ...
Cached Biology Technology:GeneNews rolls out ColonSentry(TM) test in additional Toronto area labs 2GeneNews rolls out ColonSentry(TM) test in additional Toronto area labs 3GeneNews rolls out ColonSentry(TM) test in additional Toronto area labs 4Debiopharm and Aurigene Sign Licensing Agreement for the Development and Commercialisation of Debio 0617, a Novel Inhibitor of an Undisclosed Oncology Pathway 2Debiopharm and Aurigene Sign Licensing Agreement for the Development and Commercialisation of Debio 0617, a Novel Inhibitor of an Undisclosed Oncology Pathway 3Med Discovery and Laborium Biopharma Sign a Bioprocess Development Partnership Agreement 2
(Date:3/23/2015)... 2015 SoundView Technology Group issues a new research ... ) Wocket smart wallet. SoundView was one of the selected user ... with the Wocket in multiple scenarios and outlets. ... other retailers, making both debit and credit card payments.  ... "If the company meets their plans in 2015, it would ...
(Date:3/23/2015)... OXFORD, Conn. , Mar. 23, 2015 NXT-ID, Inc. ... authentication company focused on the growing mobile commerce market, announces ... a new advertising campaign on CNBC television starting March 30 ... ads will commence airing in New York ... Executive Officer said: "We are excited about our new ad ...
(Date:3/20/2015)... Conn. , March 20, 2015 NXT-ID, ... a biometric authentication company focused on the growing mobile ... smart wallet is one of the products featured in ... March 20th at 11:00 PM EST on the DIY ... to Las Vegas , site of ...
Breaking Biology News(10 mins):Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 2Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 3Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 4NXT-ID's Wocket Smart Wallet to Launch New CNBC Regional TV Ad Campaign 2NXT-ID's Wocket Smart Wallet to Launch New CNBC Regional TV Ad Campaign 3NXT-ID's Wocket Biometric Smart Wallet to Air on "I Want That" International CES Special 2NXT-ID's Wocket Biometric Smart Wallet to Air on "I Want That" International CES Special 3
... Patients with symptomatic moderate asthma who were treated ... antibody, experienced significantly fewer disease exacerbations than individuals ... the first issue for October 2006 of the ... published by the American Thoracic Society. , Trevor ...
... harnessing of 'T-rays' - electromagnetic terahertz waves - which ... varied as biological cell abnormalities and explosives has been announced. ... in Spain have said they have found a way to ... Their findings are set out in a letter published in ...
... theories regarding consciousness, emotion and quality of life ... (ALS, also known as 'Lou Gerhig's disease') are ... interaction. ALS is a progressive disease that destroys ... latest issue of Psychophysiology. The article reviews the ...
Cached Biology News:Monoclonal antibody reduces exacerbations in asthmatics 2T-ray breakthrough could make detecting disease far easier 2Computer with brain connections changing quality of life of paralyzed 2
... DASGIP Overhead Drive for individual and ... for flexible agitation of DASGIP vessels, featuring ... impellers. ,Up to 16 overhead drives ... DASGIP Cultivation Systems fedbatch-pro® and cellferm-pro® for ...
... IonQuest will provide great value plus ... detector has very high sensitivities and ... to the standard conductivity detector, the IonQuest ... as electrochemical, refractive index, UV/Visible, WaveQuest UV/Visible ...
This pump accomodates StemSep ; pump feed columns of the following sizes : 0.3in., 0.5in., 0.6in., and 1.0in.....
...
Biology Products: