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

uss, clarify and reach alignment on a resubmission plan to fully address all deficiencies and issues identified in the CRL. The FDA indicated that, in its view, Savient's plan to revert to and validate the original manufacturing process used to produce the Phase 3 clinical trials material, together with the inclusion of additional 0.22 micron filters in the manufacturing process, is a reasonable approach that the FDA expects will produce drug substance that is representative of that used in the pivotal Phase 3 clinical trials. The FDA stated that it also expects that the comparability between material produced with the validated Phase 3 process and the Phase 3 clinical trial material used in the replicate clinical trials to establish safety and efficacy can be sufficiently established by quality criteria alone without the need to conduct additional clinical studies, provided no significant differences between products are observed.

The FDA also agreed at this meeting with the methods and criteria proposed by Savient to tighten manufacturing analytical methods and acceptance criteria for all manufacturing steps in the final commercial production process. However, some of these final analytical methods and acceptance criteria are subject to being set based upon the data from historical manufacturing and validation batches that will be included in the resubmission. The meeting outcomes confirm Savient's belief that it is on track to meet its previously discussed timeline of filing the resubmission in response to the CRL in early 2010.

The FDA also provided additional clarity relating to the steps necessary for Savient's drug substance manufacturer, Bio-Technology General (Israel) Ltd (BTG), a subsidiary of Ferring Pharmaceuticals, to satisfactorily correct the observations cited by the FDA during its pre-approval inspection of the BTG manufacturing facility. Savient believes that BTG's remediation of these observations can be
'/>"/>

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:12/24/2014)... GMO corn cases filed across the United ... the process of being consolidated in a Kansas federal ... Re: Syngenta AG MIR 162 Corn Litigation, MDL No. ... of Kansas. , Management of the Syngenta GMO corn ... District Judge John W. Lungstrum.* , As a Missouri ...
(Date:12/24/2014)... New York (PRWEB) December 23, 2014 According ... the Long Island Affiliate of ITRA Global, the national office ... but steady recovery. This is evidenced by the third ... strong stock market. Low energy costs have held inflation ... The only negative is the housing market remaining soft. , ...
(Date:12/24/2014)... 23, 2014 Pipette.com announces their ... followers can submit their #HolidayInTheLab pictures for a chance ... mates. , For those struggling to think of a ... Holiday in the Lab Contest provides the ideal holiday ... to send pictures of their chemistree, holiday sweaters, ...
(Date:12/24/2014)... ST. LOUIS , Dec. 23, 2014 /PRNewswire/ ... announced today that the waiting period under the ... with the acquisition expired on December 22, 2014, ... and review requirement for the acquisition of the ... U.S. antitrust clearance satisfies another condition to ...
Breaking Biology Technology:Carey Danis & Lowe Reports on Syngenta GMO Corn Transfer Order 2ITRA 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 3Major Pipette Distributor Pipette.com Announces their Holiday in the Lab Contest 2Acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany, Receives U.S. Antitrust Clearance 2Acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany, Receives U.S. Antitrust Clearance 3
... DUBLIN and PHILADELPHIA , June 3, 2010 ... biopharmaceutical company,announces that its subsidiary Shire LLC has filed a lawsuit in ... Pharmaceuticals,Inc. and Anchen, Inc. (collectively "Anchen") for the infringement of U.S.,Patent Nos. ... , , , ...
... June 3 /PRNewswire-Asia-FirstCall/ -- Tianyin,Pharmaceutical Co., Inc. (NYSE Amex: TPI ), a biopharmaceutical company ... website: , , , ... , , ... , Tianyin ...
... 2 The Libyan government has instructed UK-based Trimega Laboratories ... remains of the passengers who died when Afriqiyah Airways Flight 771 from ... , , ... onboard the Airbus A330-200 perished - with 70 of the dead originating ...
Cached Biology Technology:INTUNIV(TM) - Shire Files Suit Against Anchen Pharmaceuticals, Inc. and Anchen, Inc. 2INTUNIV(TM) - Shire Files Suit Against Anchen Pharmaceuticals, Inc. and Anchen, Inc. 3Tianyin Corporate Presentation Updated 2Libyan Air Crash DNA Samples to Trimega Laboratories for Analysis 2
(Date:12/17/2014)... 16, 2014  Automation is fundamentally transforming the ... than at international borders. Over the past decade, ... allowed veteran travelers to self process through border ... Kiosks at an increasing number of airports, seaports, ... According to Maxine Most , Principal ...
(Date:12/11/2014)... --Research and Markets , ... ) has announced the addition of the ... their offering. One major trend ... multimodal biometric systems. Multimodal biometric systems utilize more ... and identification purposes. This helps to reduce the ...
(Date:12/10/2014)... 8, 2014 You,ve been here before: you desperately ... remember your password, site key or the answer to your ... grade teacher? Today, Hoyos Labs , ... that will finally put an end to the frustration that ... . 1U leverages a user,s smartphone to acquire his ...
Breaking Biology News(10 mins):Automated Border Control (ABC) Transforms the Global Travel Experience With More Than 2500 ABC eGates and APC Kiosks Deployed In Airports, Seaports, and Land Borders Worldwide 2Biometrics Market in India 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 3
... WORCESTER, Mass. A collaboration between the University of ... at Tufts University and the Broad Institute at the ... on canine chromosome 7 which coincides with an increased ... published in the January 2010 edition of Molecular ...
... can conserve fish and eat them too, according to ... a team of experts. "We found that if ... you can put the Marine Protected Areas in the ... more profitable," said Christopher Costello, economist and professor with ...
... at Cold Spring Harbor Laboratory (CSHL) have discovered how ... of DNA replication actually triggers this process in cells. ... kinase), is an enzyme that attaches phosphate molecules to ... has found that DDK performs this operation, called phosphorylation, ...
Cached Biology News:Canine compulsive disorder gene identified 2Environmentalists and fishing community can both win, say experts 2CSHL scientists uncover role of protein critical for activating DNA replication 2
An excellent carbonyl-reactive FRET quencher paired with Trp or Tyr. Minimum Purity: 95%. Abs(max): ~350 nm; Em(max): none. Solvent System:DMSO or DMF....
This antibody detects an ~92 kDa protein corresponding to the apparent molecular mass of the beta subunit of Hypoxia Inducible Factor-1 (HIF-1beta) on Western blots....
BI-1 Polyclonal Antibody Storage Temperature: -20C Shipping: gel pack Shelf-Life: 12 months...
Complexin-1/2 (FL-134)...
Biology Products: