Navigation Links
Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)
Date:8/2/2009

) (pegloticase), a meeting with the FDA to discuss the complete response letter, the reversion to and revalidation of the Phase 3 manufacturing process, the terms of a REMS program, the timing of a resubmission to the FDA in response to the complete response letter and the efficacy and safety of KRYSTEXXA are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our assessment and interpretation of the currently available data and information, our Phase 3 clinical data, our current understanding of the complete response letter and on current expectations, assumptions, estimates and projections about our business and the biopharmaceutical and specialty pharmaceutical industries in which we operate. Important factors that may affect our ability to achieve the matters addressed in these forward-looking statements include, but are not limited to, the possibility that the FDA may raise further issues regarding the BLA for KRYSTEXXA or require that we conduct additional clinical trials, our ability to commercialize and market acceptance of KRYSTEXXA; difficulties in obtaining financing; potential development of alternative or more effective products by competitors; reliance on third parties to manufacture, market and distribute many of our products; economic, political and other risks associated with foreign operations; risks of maintaining protection for our intellectual property; risks of an adverse determination in intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical industry and other important factors set forth more fully in our reports filed with the Securities and Exchange Commission, to which investors are referred for further information. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements, which speak
'/>"/>
SOURCE Savient Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine news :

1. Savient Pharmaceuticals to Present at the Credit Suisse Phoenix Healthcare Conference on November 13th
2. Savients Board of Directors Forms a Board Committee to Oversee the Regulatory and Pre-Launch Activities for Pegloticase
3. Savient Pharmaceuticals to Present at the 27th Annual J.P. Morgan Healthcare Conference on January 14th
4. Savient Pharmaceuticals Reports Fourth Quarter and Year-End 2008 Financial Results
5. Savient Pharmaceuticals to Present at The Cowen and Company 29th Annual Healthcare Conference on March 17, 2009
6. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
7. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
8. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
9. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
10. Vista Partners Updates Coverage on Tapestry Pharmaceuticals
11. Transcept Pharmaceuticals, Inc. to Present at UBS 2007 Global Life Sciences Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2015)... ... , ... Talking About Your Product Pipeline:, How FDA and SEC Regulate Life ... http://www.fdanews.com/productpipeline , When a company has a product in development, whether drug, ... tightly regulated by the FDA. , At the same time, the SEC requires that ...
(Date:7/28/2015)... West Jordan, Utah (PRWEB) , ... July 28, ... ... Medical Center West Valley Campus have received the Get With The Guidelines®-Stroke Gold ... Association for excellence in patient care and outcomes. , The Get With ...
(Date:7/28/2015)... , ... July 28, 2015 , ... ... products, announces Skimmer Helper, a household invention that cleans pools efficiently - minus ... billion," says Scott Cooper, CEO and Creative Director of World Patent Marketing. "It ...
(Date:7/28/2015)... ... July 28, 2015 , ... World ... Lost and Found, a breakthrough technological invention. It is a wearable personal ... consumer electronic industry reached a record high of $211.3 billion in 2014," says ...
(Date:7/28/2015)... ... ... Dr. Edward Buckingham and Buckingham Center for Facial Plastic Surgery, is ... to Austin from Philadelphia, Dr. Roy will be completing his Fellowship in facial plastic ... by the American Academy of Facial Plastic and Reconstructive Surgery. , Since 1969, ...
Breaking Medicine News(10 mins):Health News:FDAnews Announces — Talking About Your Product Pipeline: How FDA and SEC Regulate Life Sciences Communications Webinar, Aug. 19, 2015 2Health News:FDAnews Announces — Talking About Your Product Pipeline: How FDA and SEC Regulate Life Sciences Communications Webinar, Aug. 19, 2015 3Health News:FDAnews Announces — Talking About Your Product Pipeline: How FDA and SEC Regulate Life Sciences Communications Webinar, Aug. 19, 2015 4Health News:Jordan Valley Medical Center and Jordan Valley Medical Center West Valley Campus Receive Stroke Award 2Health News:Jordan Valley Medical Center and Jordan Valley Medical Center West Valley Campus Receive Stroke Award 3Health News:10 Fascinating Things You Never Knew About Swimming Pools Is Introduced by World Patent Marketing and Skimmer Helper 2Health News:10 Fascinating Things You Never Knew About Swimming Pools Is Introduced by World Patent Marketing and Skimmer Helper 3Health News:10 Fascinating Things You Never Knew About Swimming Pools Is Introduced by World Patent Marketing and Skimmer Helper 4Health News:10 Fascinating Things You Never Knew About Swimming Pools Is Introduced by World Patent Marketing and Skimmer Helper 5Health News:Getting Back to Basic with Bluetooth Is What the World Patent Marketing Review Team and Lost and Found Are All About 2Health News:Getting Back to Basic with Bluetooth Is What the World Patent Marketing Review Team and Lost and Found Are All About 3Health News:Getting Back to Basic with Bluetooth Is What the World Patent Marketing Review Team and Lost and Found Are All About 4Health News:Getting Back to Basic with Bluetooth Is What the World Patent Marketing Review Team and Lost and Found Are All About 5Health News:Buckingham Center for Facial Plastic Surgery Welcomes Fellow 2Health News:Buckingham Center for Facial Plastic Surgery Welcomes Fellow 3
... were more likely to report a family history of ... who did not have prostate// cancer, according to researchers ... ,The data were part of the Flint Men’s Health ... who live in Flint, Mich. The Flint Men's Health ...
... is not well and cannot attend court the next three ... ago following chest pain. ,"He is not well. I ... court proceedings for the next three days," said Shakti Gupta, ... Sciences (AIIMS). ,According to Gupta, six heart ...
... boost its health tourism industry in the US, says an ... of Kerala Associations in North America (Fokana), which has members ... Kerala governments to promote the state as a destination for ... attention of the entire US. If Kerala does it, there ...
... Tuberculosis, a highly communicable disease, has turned out to be ... affected nations in the world. It is estimated //that nearly ... ,This has raised the concern of Kenyan doctors and ... label tuberculosis as a national debacle and formulate special laws ...
... to see that a robust and effective legislation which ... life is brought into force within the next six ... AIDS Day organized by Parliamentarians Forum on HIV/AIDS and ... following suggestions to MPs, research laboratories, the Pharma industry ...
... the Western Pacific region to take action to curb HIV. ... in Aids infection with figures escalating to 8.6 million. Only ... year. WHO has issued the call to governments to intervene ... virus. ,Mr. Shigeru Omi, the director for ...
Cached Medicine News:Health News:African-Americans With Prostate Cancer More Likely to Have Family History 2Health News:President Urges to Avoid Discrimination Against AIDS Patients 2
(Date:7/28/2015)... -- A German Diabetes Center clinical study found that ... enriches human gut microbiota and modifies gut production of ... daily administration of Nutraceutix,s L. reuteri strain ... tract ® delivery technology that protects live ... to the intestinal tract. The randomized, double-blind, ...
(Date:7/28/2015)... The Physician-Patient Alliance for Health & Safety ... Surviving Your Hospital Stay ." "Help us ... of these patients went home from hospital," said ... referring to the patient stories presented at ... Promote Continuous Monitoring of Patients on Opioids (shown ...
(Date:7/28/2015)... TAMPA, Fla. , July 28, 2015  For ... by their researchers, physicians and other inventors can be ... to market is difficult, and successes are rare. ... wants to change that. Medical Device ... technology licensed from universities, hospitals and physicians. MDI develops, ...
Breaking Medicine Technology:Nutraceutix's L. reuteri Probiotic Clinically Proven to Modulate Gut Insulin Metabolism 2Surviving Your Hospital Stay: Physician-Patient Alliance for Health & Safety Launches Fundraising for Patient Safety 2Medical Device Investments To Become Center Of Excellence For The Commercialization Of Innovative Medical Technologies 2
... Significance, FRAZER, Pa., May 01, 2007 /PRNewswire-FirstCall/ ... presented today at the 59th Annual,Meeting of ... highlights,data demonstrating that FENTORA(R) (fentanyl buccal tablet) ... pain in patients,with neuropathic pain who are ...
... Inc. (NYSE:DNA),and Biogen Idec, Inc. (Nasdaq:BIIB) announced ... study of Rituxan(R) (rituximab) in,patients with relapsing-remitting ... American Academy of Neurology annual meeting,held in ... targets and,selectively depletes CD20-positive B-cells., "There remains ...
Cached Medicine Technology:Cephalon Presents Positive Results for Fentora in Breakthrough Pain,Associated with Neuropathic Conditions 2Cephalon Presents Positive Results for Fentora in Breakthrough Pain,Associated with Neuropathic Conditions 3Cephalon Presents Positive Results for Fentora in Breakthrough Pain,Associated with Neuropathic Conditions 4Cephalon Presents Positive Results for Fentora in Breakthrough Pain,Associated with Neuropathic Conditions 5Cephalon Presents Positive Results for Fentora in Breakthrough Pain,Associated with Neuropathic Conditions 6Cephalon Presents Positive Results for Fentora in Breakthrough Pain,Associated with Neuropathic Conditions 7Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology 2Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology 3Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology 4Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology 5Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology 6
Galt Skull Trephine with adjustable centering point and detachable cross-bar handle, 19.0 mm....
Greenberg micro instrument holder is a flexbar arm used to hold micro instruments used repeatedly within retracted fields. Holds instruments with shafts up to 1/8 in diameter....
Length-9 (229 mm) Tapered retractor blades. 1/16 x 1/4 (1.6 mm x 19 mm)....
Kit is supplied with four secondary bars. Secondary bars attach to primary bar. Length 12 (305 mm)....
Medicine Products: