Navigation Links
Genzyme Announces Results of Clinical Trials Investigating Powder,Form of Sevelamer Carbonate

agel.

With today's results, Genzyme has concluded that the powder formulation of Renvela dosed three times per day may represent a promising alternative for patients with chronic kidney disease. The company will continue to move ahead aggressively with clinical and regulatory plans for the powder formulation dosed three times per day, and these data will form part of an NDA submission in the first half of 2008.

"We are very pleased with the progress we have made to date in our multi- faceted development program for Renvela, including filing an NDA for patients on dialysis, completing a successful trial in the pre-dialysis population, and demonstrating the effectiveness of the powder formulation dosed three times per day," said John P. Butler, president, Genzyme Renal. "Results of the once- per-day trial were greatly influenced by the strong phosphorus reduction seen in the Renagel arm, which was superior to that seen in all but one previously conducted clinical trials. While today's results will not currently support a regulatory filing for once-per-day dosing, they are clinically meaningful and give us confidence that this approach can be effective. We will continue to work with regulatory authorities to design an appropriate clinical plan to gain approval for this dosing regimen."

About Renvela

Renvela is a buffered form of Renagel, the most-prescribed phosphate binder in the United States. Like Renagel, Renvela is a calcium-free, metal- free, non-absorbed phosphate binder, and will be available as 800mg tablets once approved. A New Drug Application for Renvela is currently under review by the US Food and Drug Administration for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

In April, Genzyme announced that a new clinical trial showed that Renvela significantly reduced serum phosphorus, calcium-phosphorus product and LDL cholesterol in hyperphosphatemic patients with chronic kidney disease wh
'"/>




Page: 1 2 3 4 5

Related medicine technology :

1. Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea
2. Genzyme Announces Results of Clinical Trial of Hylastan
3. Genzyme Announces Results of Clinical Trials Investigating Powder Form of Sevelamer Carbonate
4. Genzyme and Bayer HealthCare Announce Detailed Interim Two-Year Alemtuzumab in Multiple Sclerosis Data Presented at AAN
5. Genzyme Announces Successful Completion of Study Investigating Sevelamer Carbonate in Patients With Chronic Kidney Disease
6. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
7. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
9. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
10. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
11. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
Post Your Comments:
(Date:1/23/2015)... Cord Blood America, Inc. ( www.cordblood-america.com ) (OTC Bulletin Board: ... Preliminary Proxy Statement, Schedule 14A, with the U.S. Securities & ... for shareholders detailing why a "YES" vote to increase the ... As we reflect upon the 2014 fiscal year ...
(Date:1/23/2015)... , Jan. 23, 2015  CytoSorbents Corporation (NASDAQ CM: ... CytoSorb® extracorporeal cytokine adsorber to reduce deadly inflammation ... receipt of $385,642, net of transaction costs, in ... Technology Business Tax Certificate Transfer Program sponsored by ...
(Date:1/23/2015)... BIRMINGHAM, Ala. , Jan. 23, 2015 Gem ... (STS) patients have been enrolled into the Company,s Phase ... efficacy and safety of Gem,s lead compound, GPX-150 (an ... for advanced or metastatic disease. Logo - ...
Breaking Medicine Technology:Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 3Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 4CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 3Gem Pharmaceuticals Announces Enrollment of Initial Patients in its Phase 2 Clinical Trial to Assess the Efficacy and Safety of GPX-150 in Sarcoma Patients 2
... Bayer HealthCare LLC announced today that it has ... and Farnam Companies Inc. over Farnam,s advertising for its ... of the settlement, Farnam has agreed to withdraw the ... campaign included claims that Bio Spot® was "as effective ...
... CLARA, Calif., June 17, 2011 NewCardio, Inc., (OTC ... that Vincent Renz, Chief Executive Officer, is scheduled to ... Conference is on June 22 and 23, 2011, at ... 3:30 p.m. ET on Wednesday, June 22. ...
Cached Medicine Technology:Bayer Announces Farnam Companies' Agreement to Halt Disputed Bio Spot® Ads 2NewCardio to Present at Wells Fargo Securities Healthcare Conference 2NewCardio to Present at Wells Fargo Securities Healthcare Conference 3
(Date:1/23/2015)... AZ (PRWEB) January 23, 2015 Hastings and ... injury matters, reports a record number of legal representation client ... speaking, there has been a steady rise in the number ... work and at home throughout the Valley. With that said, ... accident be reviewed by an experienced law firm. Hastings and ...
(Date:1/22/2015)... its top dressmaking technologies, has been a leading dress supplier ... latest designs of wedding dresses and launching a site-wide promotion ... the fresh new products are designed for 2015, and they ... All the clothes from LunaDress follow up with the latest ...
(Date:1/22/2015)... 22, 2015 Padre Murphy's and Owner Tom ... Pro Player Health Alliance (PPHA). The PPHA's passion ... getting everyone, including NFL greats, treated for obstructive sleep apnea ... groups supporting the cause in the valley. The most recent ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Blue Cross and ... Minnesotans who exemplify what it means to “Live Fearless.” ... for people to share their stories about how they or ... simply inspired others by living in the moment. By telling ...
(Date:1/22/2015)... 2015 A new white paper by ... person-centeredness in the long-term care environment as well as ... continuum. The paper, “The Power of Person-Centeredness in Long-Term ... practices of the patient, resident and family experience in ...
Breaking Medicine News(10 mins):Health News:Hastings and Hastings Reports a Record Number of Client Review Requests for Slip and Fall Accidents in 2014 2Health News:LunaDress Shows The Latest Styles Of Wedding Dresses In 2015 2Health News:Padre Murphy's Holds NFL Retired Players Association Party Star Studded Event With Bud Light and Pro Player Health Alliance Sponsoring 2Health News:Padre Murphy's Holds NFL Retired Players Association Party Star Studded Event With Bud Light and Pro Player Health Alliance Sponsoring 3Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3
... ST. LOUIS, June 5 Celebrities, from high-profile,athletes to ... products,including expensive energy drinks and even candy bars, are ... it is the nutrient fad of the,moment., Fleming ... on the market ranged from 40% all the way ...
... Diana Kirschner Explains the Psychology Behind It, NEW ... an estimated,$55.7 million for its opening weekend, beating out ... other romantic comedy has ever,opened with such a lucrative ... occurring," says Dr. Diana Kirschner, psychologist and,recurring relationship expert ...
... Expects FDA to Request Additional Safety Study Prior to ... Inc.,(Nasdaq: IDEV ) today announced that based on ... (FDA) regarding the NDA filing for,NEBIDO(R), the Company expects ... safety data prior to approving NEBIDO. The Company,currently believes ...
... risk of developing rheumatoid arthritis by up to 50%, ... of the Rheumatic Diseases. , The Scandinavian researchers base ... in two separate studies, which assessed environmental and genetic ... the participants (1650) had the disease and had been ...
... FALLS CHURCH, Va., June 4 CSC (NYSE: ... Dell Inc. (Nasdaq: DELL ) to design and,deploy ... and,complexity out of their information technology (IT) environment and ... help clients,simplify processes associated with IT and enhance innovation ...
... to Ensure Equitable Protections,for All Americans and Their ... America,s,Health (TFAH) issued the following statement on the ... Services(HHS) Draft Guidances to Assist in,Preparation for an ... government must do all it can to ensure ...
Cached Medicine News:Health News:The Vitamin B12 Craze - Super Nutrient or Super Hype? 2Health News:Why is the Sex & the City Movie a Mega-Blockbuster? 2Health News:Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status 2Health News:Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status 3Health News:Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status 4Health News:Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status 5Health News:Regular tipple may curb risk of rheumatoid arthritis 2Health News:CSC to Simplify IT From Desktop to Data Center 2Health News:Trust for America's Health on New HHS Influenza Pandemic Draft Guidance 2
... The Optimal temporary implant for use with ... The pupil dilator type 5S is a ... of the pupil during phacoemulsification. It is ... use. Indication: Expansion of the pupil during ...
... coated with a thin layer ... the surface slick as glass ... prevent debris from collecting on ... For partial stenosis. Silicone with ...
For use with Crawford Intubation Systems....
... prolene as thread-guide reducing time and trauma ... Probe is inserted into the nasolacrimal duct ... through it. The probe is then withdrawn ... silicone tubing in place. Canalicular Laceration or ...
Medicine Products: