Navigation Links
Genzyme Receives FDA Response Letter on Synvisc-One(TM)
Date:11/13/2007

.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

This press release contains forward-looking statements, including Genzyme's expectation for receipt of US marketing approval of Synvisc-One and the revised timing thereof, its belief that a single-injection regimen of Synvisc will simplify pain management, provide additional patient convenience, reduce costs and expand the viscosupplementation market, and Genzyme's plans to pursue marketing approvals in additional jurisdictions. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, among others, Genzyme's ability to adequately respond to the questions raised by the FDA and to do so in a timely fashion, the extent to which the FDA determines that Synvisc-One can appropriately be approved for marketing in the US, the extent to which the government and private insurers recognize the benefits of Synvisc-One and maintain or otherwise implement reimbursement policies that reflect these benefits, and the risks and uncertainties described in reports filed by Genzyme with the U.S. Securities and Exchange Commission, including without limitation the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the quarter ended September 30, 2007. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements
'/>"/>

SOURCE Genzyme Corporation
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Elliott Extremely Dissatisfied With Genzyme Bid for Bioenvision; Believes Offer Significantly Undervalues Company
2. Delaware Court Approves Bioenvision, Genzyme Joint Petition
3. Genzyme and Bayer Schering Pharma AG, Germany to Present New Data on Alemtuzumab in Multiple Sclerosis at ECTRIMS
4. Genzyme Statement Regarding Results of FDA Advisory Committee Meeting on the Use of Phosphate Binders in Chronic Kidney Disease
5. Bioenvision Shareholders Approve Acquisition by Genzyme Corporation
6. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
7. DaVita Receives Civil Complaint
8. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
9. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
10. Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
11. PainCare Receives $14.4 Million in Cash From Completed Sale of South Florida Ambulatory Surgery Centers

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/23/2009)...tes Department of Agriculture (USDA) has awarded a... University of Minnesota to complete sequencing th...lopavo. The funding will be used by the Turkey Gen...equencing using next-generation sequencing platfor...es and functions in the final genome sequence by u...
(Date:11/23/2009)...-FirstCall/--AnnTaylorStoresCorp.announcedtodaytha...lThanksandGivingcampaign,aholidayfundraisingandawa...ThisyearmarksthethirdyearthatAnnTaylor,throughitsA...nthecampaignwhereweofferourshoppersanopportunityto...ppingthisholidayseason.ClientswhoshopatAnnTaylor,L...
(Date:11/23/2009)...ire/--Thanksgivingweekendmarksthe36thannualStateFa...icrepresentsthesportsmanshipandprideoftwoschoolsbu...hoseinattendance. ,, ForthecrewofthenewU.S.Coas...mebeforetheyworktotestandlaunchabrandnewshiptoprot...ttyOfficerClaudeBovellandtherestofthecrewwillbegin...
(Date:11/23/2009)...ally modified to produce bacterial proteins that a...have been planted on more than 200 million hectare...ed after the bacterium Bacillus thuringiensis , c...allowing farmers to save money and lessen environm...However, since insects can evolve resistance to to...
(Date:11/23/2009)...ger to get sick, study finds , , MONDAY,...t a genetic variation appears to play a major role...tients. , In fact, those with the variation a... of complications of the disease. , "We,re ho...at make a person more or less susceptible to HIV, ...
Breaking Medicine News(10 mins):Health News:Turkey Genome Sequencing Consortium awarded $0.9 million from USDA 2Health News:Ann Taylor Stores Corp. Returns To St. Jude Children's Research Hospital's Thanks and Giving Campaign(R) For The Third Year 2Health News:Nothing Is Like Being There 2Health News:Insect resistance to Bt crops can be predicted, monitored and managed 2Health News:Genetic Variant Slows AIDS Progression 2
... Leading Researchers to Discuss, State of Breast ... Cures, BOSTON, April 9 The Massachusetts Affili...posium April 10 at Harvard Medical,School, featuri...d the need for more funding to ensure that critica...
...s becoming popular, survey finds , , WEDNE...ondents to a new survey acknowledges using so-call... heart medications -- to stimulate their focus, co...ut has emerged in recent years as a campus "study ...
...Care and Frida,Kahlo Store are proud to announce t...8 for the benefit of The Leukemia & Lymphoma Socie...sance, located at 2131 Hylan,Boulevard, Staten Isl... problems., The event will consist of a dinner-co...
...ia,Academy of Family Physicians Foundation (PAFP/F...amily medicine student scholarship programs., "Th...dle the continuing,demand for primary care," said ...we have to make sure they get every,opportunity to...
...n the United,States has doubled in the last 30 yea...tom lines, according to a new report from The Conf... fit the definition of "obese.",Obese employees co...yers Should Know about,Obesity, The Conference Boa...
...ingerprint associated with normal embryonic stem c...tion of cancer stem cells. The research, published...m Cell, demonstrates that embryonic stem cells and...nificant clinical implications for cancer therapeu...
Other Medicine News:Health News:Massachusetts Affiliate of Susan G. Komen for the Cure to Spotlight Gaps in Breast Cancer Research 2Health News:Unlikely Drugs Emerge as 'Cognition Enhancers' 2Health News:PAFP Golf Tournament to Benefit Student Programs 2Health News:Obesity Costs U.S. Companies as Much as $45 Billion a Year, The Conference Board Reports 2Health News:Obesity Costs U.S. Companies as Much as $45 Billion a Year, The Conference Board Reports 3Health News:Module map links embryonic stem cells and cancer stem cells 2
(Date:11/23/2009)...,Texas,Nov.23/PRNewswire-FirstCall/-- LexiconPharm...top-linedatafromitsPhase2clinicalstudywith LX1031 ...me(IBS)willbepresentedatGASTRO2009inLondonthisweek...ementinIBSsymptoms,willbepresentedbyDr. PhilipM.Br...ment,onNovember25,2009at2:30pmlocaltimeatthesessio...
(Date:11/23/2009)...xas,Nov.23/PRNewswire-FirstCall/--WoundManagementT...owingproviderofspecialtymedicalproducts,announcedt...dacomprehensivemanagementbusinessupdatetoillustrat...Q32009salesincreased33.5%to$102,926vs.Q32008saleso...reasedto$3,327,892vs.Q32008shareholderequityof$(32...
(Date:11/23/2009)...CISCO,Calif.,Nov.23/PRNewswire-FirstCall/--Anesiva...andDr.DavidC.U,PrichardhaveagreedtojointheAnesivab...gerbetweenAnesivaandArcionTherapeutics.Completiono...keplaceatthepreviouslyannouncedAnesiva2009AnnualMe...a.m.PSTat400OysterPoint,Suite107A,SouthSanFrancisc...
Breaking Medicine Technology:Lexicon to Present Positive Top-Line Phase 2 Results for LX1031 in Non-Constipating Irritable Bowel Syndrome at GASTRO 2009 2Lexicon to Present Positive Top-Line Phase 2 Results for LX1031 in Non-Constipating Irritable Bowel Syndrome at GASTRO 2009 3Wound Management Technologies (OTCBB: WNDM) Reports Revenue Increase of 33.5%; Posts Evidence-Based Studies for CellerateRx; and Business Update 2Wound Management Technologies (OTCBB: WNDM) Reports Revenue Increase of 33.5%; Posts Evidence-Based Studies for CellerateRx; and Business Update 3Wound Management Technologies (OTCBB: WNDM) Reports Revenue Increase of 33.5%; Posts Evidence-Based Studies for CellerateRx; and Business Update 4Wound Management Technologies (OTCBB: WNDM) Reports Revenue Increase of 33.5%; Posts Evidence-Based Studies for CellerateRx; and Business Update 5Anesiva Announces Prospective Board Members To Be Appointed Upon Successful Completion of Proposed Merger 2Anesiva Announces Prospective Board Members To Be Appointed Upon Successful Completion of Proposed Merger 3FDA Approves Lamictal 28R 29XR 28TM 29 3B An Extended Release Once Daily New Generation Treatment for Epilepsy 47447 1FDA Approves Lamictal 28R 29XR 28TM 29 3B An Extended Release Once Daily New Generation Treatment for Epilepsy 47447 2FDA Approves Lamictal 28R 29XR 28TM 29 3B An Extended Release Once Daily New Generation Treatment for Epilepsy 47447 3FDA Approves Lamictal 28R 29XR 28TM 29 3B An Extended Release Once Daily New Generation Treatment for Epilepsy 47447 4FDA Approves Lamictal 28R 29XR 28TM 29 3B An Extended Release Once Daily New Generation Treatment for Epilepsy 47447 5FDA Approves Lamictal 28R 29XR 28TM 29 3B An Extended Release Once Daily New Generation Treatment for Epilepsy 47447 6For Patients With Irritable Bowel Syndrome 28IBS 29 iPhone to the Rescue 47442 1For Patients With Irritable Bowel Syndrome 28IBS 29 iPhone to the Rescue 47442 2For Patients With Irritable Bowel Syndrome 28IBS 29 iPhone to the Rescue 47442 3NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD 26 NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS 12377 1NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD 26 NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS 12377 2NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD 26 NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS 12377 3NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD 26 NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS 12377 4NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD 26 NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS 12377 5NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD 26 NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS 12377 6NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD 26 NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS 12377 7NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD 26 NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS 12377 8
...an Biosciences,Incorporated (Nasdaq: KOSN ) today...tanespimycin, the company,s lead Hsp90 inhibitor, ...(R) in patients with HER2-positive,metastatic brea...can,Society of Clinical Oncology (ASCO), being hel...une 3, 2008., Abstract 1027, titled, "Phase 2 tri...
... Review Data Tuesday, May 13 at 1:00 p.m. EDT ...A, Spain and MENLO PARK, Calif., May 13 /PRNewswir... announced positive six-month follow-up,data from ...safety and,efficacy of the Custom NX(R) drug eluti...s with coronary artery disease., The CUSTOM III c...
Other Medicine Technology:Kosan Announces Data Presentations at ASCO 2008 Annual Meeting 2Kosan Announces Data Presentations at ASCO 2008 Annual Meeting 3XTENT Announces Positive Six-Month CUSTOM III Trial Data Presented at EuroPCR Meeting 2XTENT Announces Positive Six-Month CUSTOM III Trial Data Presented at EuroPCR Meeting 3XTENT Announces Positive Six-Month CUSTOM III Trial Data Presented at EuroPCR Meeting 4
...6 mm tip is angled 90 degrees with 1 mm flattened ...ure extension tube (0.03 inch ID x 8 inch long), f...r dissecting pre-retinal and other vitreo-retinal ..., angled tip of 30 gauge cannula facilitates place...
Vitreoretinal Micro Cannula
Moist Air Humidifying Chambers
Eye Garter Shield Cover - white
Medicine Products: