Newspaper article from our research archive:
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ZymoGenetics.(BLOOD & BIOLOGICS)
- Article from:
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Warning Letter Bulletin
- Article date:
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June 1, 2008
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Copyright informationCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Seattle, WA, April 25 (CBER)
The Advertising and Promotional Labeling Branch (APLB) of FDA's Center for Biologics reviewed information on the website http://www.zymogenetics.com including a press release for Recothrom (Thrombin, Topical (Recombinant)) and concluded that this promotional material is false or misleading because it omits material facts about Recothrom.
Recothrom is a coagulation protein produced via recombinant DNA technology from a genetically modified Chinese Hamster Ovary (CHO) cell line. The "Indications and Usage" section of the FDA-approved labeling (PI) states "RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding ...
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Is there room in the market for a recombinant thrombin?
Drug Topics;
March 10, 2008 ;
Magill-Lewis, Jillene;
787 words
......explained. In fact, bovine thrombin is used in...recombinant thrombin (Recothrom) and partnered...compete with bovine thrombin, which has...events with bovine thrombin have been few...indicating bovine thrombin was direcdy...numbers than with bovine ...
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Risk and clinical significance of developing antibodies induced by topical...
Archives of Pathology & Laboratory Medicine;
October 1, 1998 ;
Dorion, R Patrick; Hamati, Husam F; Landis, Beth; Frey, Carolin; Et al;
787 words
......development in patients exposed to topical bovine thrombin preparations. Design.-A prevalence...individuals previously exposed to topical bovine thrombin was done by screening using Western blot assay to detect antibodies against bovine thrombin preparations. Setting.-A large ...
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DOCTOR ISSUES WARNING ON BLOOD CLOT AGENT
United Press International;
October 31, 2001 ;
511 words
......studies involving mice show the agent bovine thrombin potentially could cause an autoimmune...where the body attacks its own tissue. Bovine thrombin is an enzyme extracted from cow blood...procedures. The problem, Lawson said, is bovine thrombin is so effective and convenient, ...
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Validation of a prion and virus purification process in the manufacture of...
Journal of Applied Research;
September 1, 2007 ;
Terrab, Abdel Pawlak, Dan;
787 words
......Northborough, MA) during manufacture of bovine thrombin. Methods: Purified bovine thrombin was challenged with a high-titer clarified...runs were performed on priors-spiked bovine thrombin samples and 2 filtration runs were performed...
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ZymoGenetics Discusses Detailed Results From Successful Phase 3 Trial...
PR Newswire;
September 18, 2006 ;
787 words
......The trial compared rhThrombin to bovine thrombin. As announced on September 5th 2006...immunogenicity profile as compared to bovine thrombin. Both treatments were well tolerated...randomized to receive rhThrombin or bovine thrombin; approximately half or 205 patients...
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FDA APPROVES ZYMOGENETICS' FIRST PRODUCT BIOTECH CREATES SYNTHETIC VERSION...
Seattle Post-Intelligencer (Seattle, WA);
January 18, 2008 ;
Tartakoff, Joseph;
612 words
......Administration approved its first product, Recothrom, which the company believes eventually...up 8.75 percent, or $1.05, at $13.05. Recothrom, which the company previously referred...cows, and ZymoGenetics believes that Recothrom can avoid complications that have been...
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ZymoGenetics Inc. Analyst Meeting - Final
Fair Disclosure Wire;
December 14, 2006 ;
787 words
......trial, comparing human recombinant to bovine thrombin. Our efficacy data couldn't have been...phase II. And we confirmed that the bovine thrombin did have an immunogenicity issue with...patients who came in had antibodies of bovine thrombin. And as you'll see later, the black-b...
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Market Gainer administers coverage on OMRIX Biopharmaceuticals, Inc.
M2 Presswire;
October 17, 2006 ;
787 words
......equivalence of topical human thrombin to bovine thrombin in terms of safety and efficacy. All...thrombin, the investigational product or bovine thrombin, the control. Approximately half...equivalence of topical human thrombin to bovine thrombin in terms of efficacy as determined...
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ThermoGenesis Corp. Receives Notice of Allowance of Second Patent For...
PR Newswire;
December 19, 2001 ;
684 words
......outcomes after surgical exposure to bovine thrombin http://www.ncbi.nlm.nih.gov/entrez...Abstract Exposure of mice to topical bovine thrombin induces systemic autoimmunity http...studies report an initial exposure to bovine thrombin sets up an increased risk of adverse...
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Fibrin sealant facilitates hemostasis in arteriovenous...
The American Surgeon;
August 1, 2002 ;
Schenk, Worthington G III; Goldthwaite, Charles A Jr; Burks, Sandra; Spotnitz, William D;
787 words
......comparator groups (four) of bovine thrombin (T) (Thrombogen, GenTrac Inc., Middleton, WI), pressure (P), bovine thrombin (Thrombogen, GenTrac Inc...gelatin sponges, and topical bovine thrombin, although useful, have not...
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ZymoGenetics Inc. at JPMorgan 25th Annual Healthcare Conference - Final
Fair Disclosure Wire;
January 11, 2007 ;
787 words
......formulations of antibodies against bovine thrombin, or the contaminating bovine factor...sentence. Patients with antibodies to bovine thrombin preparations should not be re-exposed...things was recombinant thrombin versus bovine thrombin, randomized, double-blind, pivotal...
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ZymoGenetics Highlights Development Programs at Analyst & Investor...
PR Newswire;
December 8, 2005 ;
787 words
......clinical trial comparing rhThrombin to bovine thrombin (the currently marketed product) in...associated with the currently marketed bovine thrombin product. Dr. Lawson is a faculty member...extensively studied the immunogenicity of bovine thrombin and the relationship to ...
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Omrix reports positive results in Phase III clinical trials: Omrix has...
Globes (Tel Aviv, Israel);
October 17, 2006 ;
223 words
......1:1 ratio to receive either human thrombin, the product being tested, or bovine thrombin, the control product. The results indicated that human and bovine thrombin test subjects achieved hemostasis within 10 minutes, 97.4 percent of the...
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