Navigation Links
Pegloticase BLA Filing Accepted for Priority Review by FDA
Date:12/29/2008

ANGUAGE

All statements other than statements of historical facts included in this press release are forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond our control. Words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "will" and other similar expressions help identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding our BLA filing with the FDA, a potential Advisory Committee, approval of the BLA, preparation for commercialization of pegloticase, the efficacy and safety of pegloticase and the market for pegloticase, are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our current assessment of the Phase 3 clinical data 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 delay or failure in completing development of pegloticase and developing other product candidates; our stock price and market conditions; varying interpretations of our clinical and CMC data by the FDA; delay achieving or failure to achieve FDA approval of pegloticase; inability to manufacture commercial quantities of our products; inability to gain market acceptance sufficient to justify development and commercialization costs if our products are approved for marketing; our continuing to incur substantial net losses for the foreseeable future; difficulties in obtaining financing; potential development of alternative or
'/>"/>

SOURCE Savient Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related medicine news :

1. Savients Board of Directors Forms a Board Committee to Oversee the Regulatory and Pre-Launch Activities for Pegloticase
2. Barrs BLA for Adenovirus Type 4 and 7 Live Oral Vaccines Accepted for Filing by FDA
3. Accuray Receives Nasdaq Notification Related to the Late Filing of Form 10-Q
4. Watson Announces the NDA for a 6-Month Formulation of TRELSTAR(R) Accepted for Filing by FDA for the Treatment of Advanced Prostate Cancer
5. Debiopharm Announces U.S. NDA Filing of Trelstar(R) 6-Month Formulation for Locally Advanced or Metastatic Prostate Cancer
6. KV Pharmaceutical Company Files Form Reporting Delay in Filing Second Quarter Form 10-Q
7. Corporate Parent Hospital Partners of America Files Voluntary Chapter 11 Petition; Filings do not Include any Hospital Facilities
8. VaxGen Provides Financial Update Following the Filing of Its 10-Q for Second Quarter With SEC; Results Include $8.5 Million Charge in Respect of Manufacturing Plant Asset Impairment
9. Wound Management Technologies, Inc. Announces Filing of a 510K
10. Digestive Care, Inc. Announces the Filing of the First Module of NDA Submission for PANCRECARB(R) (pancrelipase)
11. Statement Regarding the Filing of Signatures to Put the Human Embryo Stem Cell Issue on the November Statewide Ballot
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2013)... Georgia (PRWEB) May 22, 2013 ... finalists for its Better Play & Recreation Contest, ... hundreds of thousands of youth, people with disabilities, ... need of rescue. The general public is encouraged ... to help their favorite non-profit organization win the ...
(Date:5/22/2013)... 2013 BroadConnect Telecom, the leading ... security solutions in North America announced plans to ... newest BroadConnect hosted security solutions. Available on premise, ... BroadConnect’s new Security as a Service (SaaS) enables ... connection of their choice, while optimizing internal network ...
(Date:5/22/2013)... May 22, 2013 Patients with type ... therapy have better glycemic control as measured by significantly ... their condition with insulin injections, according to new findings ... (NHWS), conducted by Kantar Health . The research ... ISPOR (International Society for Pharmacoeconomics and Outcomes Research) in ...
(Date:5/22/2013)... May 22, 2013 The Report ... Resins, Melamine Formaldehyde, Melamine Urea Formaldehyde), Applications (Particle ... Global Trends and Forecasts to 2018" defines and ... of the global volume and revenue. , ... the Global Amino Resins Market with analysis of ...
(Date:5/21/2013)... May 21, 2013 Heritage Woods of ... BMA affordable assisted living community, is hosting a Quality Home ... at 2 p.m. on Tuesday, May 28. , The community, ... serves older adults of all incomes, including those on Medicaid, ... Arthritis program is open to the public. There is ...
Breaking Medicine News(10 mins):Health News:Public Voting Opens for Finalists in Synthetic Turf International’s Better Play & Recreation Contest 2Health News:BroadConnect Telecom to Launch Enterprise-Grade Hosted Security Solutions Engineered to Meet the Demands of Real World Business 2Health News:Insulin Pump Therapy Provides Better Glycemic Control Among Type 1 Diabetics, According to Kantar Health Research 2Health News:Insulin Pump Therapy Provides Better Glycemic Control Among Type 1 Diabetics, According to Kantar Health Research 3Health News:Asia-Pacific Leads in Consumption of Urea Formaldehyde Resins Followed by Europe and North America - New Report by MarketsandMarkets 2Health News:Asia-Pacific Leads in Consumption of Urea Formaldehyde Resins Followed by Europe and North America - New Report by MarketsandMarkets 3Health News:Heritage Woods of Dwight Affordable Assisted Living to Host Informational Program on the Do's and Don'ts of Arthritis 2
... guidelines for school sports, survey shows , WEDNESDAY, June ... on concussions in school sports, the majority are unaware ... most report widespread pressure to return young athletes to ... came from the C.S. Mott Children,s Hospital National Poll ...
... ... senior living communities. A senior care blog and Q&A area also offer helpful advice ... ... 2010 -- AssistedLivingFacilities.org is a new website that has launched to help senior citizens ...
... Dr. DeSilva hosts ... , ... 2010-- Want a chance to ask the health experts? Swanson Health Talk Radio, hosted by ... and authors questions covering the topics of vitamins and supplements, homeopathic medicine, exercise and fitness, ...
... ... and fitness fun for the whole family. Free to download with $.99 in-app purchase to ... streetball players and ball handlers. , ... Los Angeles, CA (PRWEB) June 16, 2010 -- Luis Da Silva Jr. aka TRIKZ ...
... ... above its laser lipolysis competitors by empowering its patients with education about liposuction and body ... ... standard of Soluna MD is its commitment to patient education. The Soluna MD staff, led ...
... ... aiding in the creation of healthy serotonin levels , ... Springville, UT (PRWEB) June 16, 2010 -- Nutrifect introduces Serofil, a ... restful sleep ; reduces cravings for junk food; and assists with healthy fat loss ...
Cached Medicine News:Health News:Parents Ill-Informed About Kids' Concussion Risks 2Health News:Seniors Have a New Resource to Research Assisted Living Housing Options 2Health News:Seniors Have a New Resource to Research Assisted Living Housing Options 3Health News:Dr. DeSilva Hosts Swanson Health Talk Radio on HealthRadio.net 2Health News:Dr. DeSilva Hosts Swanson Health Talk Radio on HealthRadio.net 3Health News:Trikz Streetball Basketball iTunes App Promotion: Only $.99 to Unlock All Content for the iPhone, iPod Touch, and iPad 2Health News:Trikz Streetball Basketball iTunes App Promotion: Only $.99 to Unlock All Content for the iPhone, iPod Touch, and iPad 3Health News:Miami's Soluna MD Educates Patients, Gains International Reputation for Excellence in Laser Lipo plus Ultrasound Technique, SmartLipo™ Ultra 2Health News:Miami's Soluna MD Educates Patients, Gains International Reputation for Excellence in Laser Lipo plus Ultrasound Technique, SmartLipo™ Ultra 3Health News:Healthy Serotonin Levels Shown to Positively Affect many Important Functions of the Mind and Body. 2
(Date:5/22/2013)... VANCOUVER, British Columbia , May 22, 2013  OncoGenex ... the development of novel therapeutics to target mechanisms of treatment ... investigational compounds, custirsen and OGX-427, will be presented as "Trials ... of the American Society of Clinical Oncology (ASCO) in ... 4. Despite the availability of drugs that ...
(Date:5/21/2013)... 2013  NxStage Medical, Inc. (Nasdaq: NXTM ... announced that it has entered into new agreements covering ... to DaVita, the kidney care division of DaVita Healthcare Partners ... For the use of products for home hemodialysis ... has executed a second amended and restated National Service ...
(Date:5/21/2013)... Calif. , May 21, 2013   Regulus ... company leading the discovery and development of innovative medicines ... Menzel , Ph.D., Chief Operating Officer and Executive ... the Deutsche Bank 38th Annual Healthcare Conference on Wednesday, ... is being held at the Westin Boston Waterfront Hotel. ...
Breaking Medicine Technology:OncoGenex Announces Multiple 'Trials in Progress' Presentations at the 2013 ASCO Annual Meeting 2OncoGenex Announces Multiple 'Trials in Progress' Presentations at the 2013 ASCO Annual Meeting 3OncoGenex Announces Multiple 'Trials in Progress' Presentations at the 2013 ASCO Annual Meeting 4OncoGenex Announces Multiple 'Trials in Progress' Presentations at the 2013 ASCO Annual Meeting 5NxStage Announces New Agreements with DaVita 2Regulus to Present at Deutsche Bank 38th Annual Healthcare Conference 2
... Inc. (NASDAQ: DCTH ) announced today that ... to the Company,s request made in September for a ... date in mid-January 2012.  Delcath plans to submit the ... treatment of patients with metastatic melanoma in the liver ...
... Mass., Oct. 26, 2011 Idenix Pharmaceuticals, Inc. (NASDAQ: ... financial results for the third quarter of 2011 on Wednesday, ... Idenix management will host a conference call at 4:30 p.m. ... financial results for the third quarter of 2011 and provide ...
Cached Medicine Technology:FDA Schedules Delcath Pre-New Drug Application Meeting Date 2FDA Schedules Delcath Pre-New Drug Application Meeting Date 3Idenix to Host Conference Call Discussing Third Quarter and Nine Month 2011 Financial Results and Announces Presentations at the American Association for the Study of Liver Diseases Meeting (AASLD) 2
The Storz Protege is an anterior segment unit only....
The Storz Premiere comes as anterior, posterior and anterior/posterior combo. The combo provides the following modes irrigation, irrigation/aspiration, vitrectomy, and illumination....
Compact ultrasonic phacoemulsification system....
... Precisionist workstation is a unique combination ... allowing infinite flexibility for modular hardware ... the demands of changing cataract surgical ... concept in ophthalmic surgical platforms providing ...
Medicine Products: