Navigation Links
Genzyme Provides Update on Myozyme(R) Manufacturing
Date:4/21/2008

Will Host Conference Call Today at 5:00 p.m.

CAMBRIDGE, Mass., April 21 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA has informed the company of its opinion that Myozyme(R) (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the 160L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale. Production at this larger scale has already been approved in more than 40 countries.

Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale, including patients who participated in the Late-Onset Treatment Study (LOTS), Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe. Myozyme is the only treatment for Pompe disease -- a severe, progressively debilitating and life-threatening inherited disorder affecting a very small number of people throughout the world.

The FDA will require Genzyme to submit a separate biologics license application (BLA) to gain approval for Myozyme produced at the 2000L scale. The agency proposed that Genzyme initiate a rolling BLA review process by submitting results from the LOTS study. Genzyme expects the FDA to give the BLA priority review and to act on the application by the end of this year. The LOTS study, which met its co-primary efficacy endpoints, was undertaken to evaluate the safety and efficacy of Myozyme in juvenile and adult patients w
'/>"/>

SOURCE Genzyme Corporation
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5

Related biology technology :

1. Genzyme Withdraws Bioenvisions European Filing of Evoltra(R) in Elderly AML Patients
2. Genzyme Launches Renvela(R) in the U.S. for Dialysis Patients
3. Genzyme and Isis Announce Hart-Scott-Rodino Approval of Collaboration
4. Genzyme and Isis Announce Strategic Alliance Including Exclusive Worldwide License of Mipomersen
5. BioMarin and Genzyme Restructure Aldurazyme 50/50 Joint Venture
6. Genzyme Receives European CE Mark for Single-Treatment Synvisc-One(TM)
7. Genzyme Announces FDA Approval of Thyrogen(R) for Use in Thyroid Cancer Ablation
8. Genzyme Study of Myozyme(R) for Late-Onset Pompe Patients Meets Co-Primary Efficacy Endpoints
9. Genzyme and Sunway to Collaborate on Gene Therapy Program in China
10. BioVex Appoints Genzyme Executive, Jan van Heek, as Chairman of the Board of Directors
11. Genzyme Launches Cholestagel(R) in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2008)...FirstCall/ -- Eli Lilly and,Company (NYSE: LLY ) ...ion,of SGX Pharmaceuticals, Inc. (Nasdaq: SGXP ),...n drug discovery and development in the area,of on...s Special,Stockholders Meeting, in which a majorit... agreement with Lilly. Under the agreement, Lilly ...
(Date:8/20/2008)... and Caregivers, Grassroots ...ewswire-USNewswire/ -- Inc. Magazine has,named Sen...an for,low-income seniors, the number one fastest-...rt of Inc.,s annual list of the country,s 500 fast...1,000 percent from 2004 to 2007., "This is a rewa...
(Date:8/20/2008)...ll/ -- CEL-SCI CORPORATION,(Amex: CVM ) reports f...ing,June 30, 2008., The Company,s loss from opera...76,679 versus a loss of $3,776,263 during the same...ns for the nine months ended June 30, 2008,was $7,...e nine months in,2007., The net loss per common s...
(Date:8/20/2008).../ -- Huifeng Bio-Pharmaceutical,Technology, Inc (O...producer of plant extracts and pharmaceutical raw ... and food production, today announced it will,be i... August 19-21 in Rio,de Janeiro, Brazil., "Unpara...volved in the,pharmaceutical raw materials industr...
Breaking Biology Technology:Lilly Announces Completion of SGX Acquisition 2Inc. Magazine Names Senior Whole Health the Number One Fastest-Growing Private Company in US 2Inc. Magazine Names Senior Whole Health the Number One Fastest-Growing Private Company in US 3CEL-SCI CORPORATION Reports Third Quarter 2008 Financial Results 2CEL-SCI CORPORATION Reports Third Quarter 2008 Financial Results 3CEL-SCI CORPORATION Reports Third Quarter 2008 Financial Results 4CEL-SCI CORPORATION Reports Third Quarter 2008 Financial Results 5Huifeng Bio-Pharmaceutical (HFGB) to Attend CPhI South America 2008 Pharmaceutical Conference; The First CPhI Conference to be held in the Emerging Market of Brazil 2
... Michael Rosencrance is a featured speaker at the ...of electronic health records. With all of the new ...cate patient records, how can individual doctors m...,Its very difficult, says Michael Rosencrance. , ,...ervices at the University of Wisconsin Medical Fou...
...David Redick knows something about venture capital...lecom entrepreneur. , ,Now Redick, a longtime deni...on, has jumped to the other side of the aisle with... capital firm focused on providing early stage fun...he information-technology sector. , ,Redick hopes ...
MG&E has released its 2005 Greater Madison Area Directory of High Tech Companies, a desk reference to 394 area firms. WTN,s Mike Klein takes you inside this valuable resource for anyone doing busines
... This is the first in a new WTN series that will f... a company. For the next few weeks, we,ll focus on.... Surgeons have little enough time without spendin... Milwaukee-area general surgeon Michael Phillips, ...tes to mark tissue cut out during cancer surgeries...
Other Biology Technology:Michael Rosencrance deals with medical overload through human-centric IT 2Michael Rosencrance deals with medical overload through human-centric IT 3New Madison VC firm Badger Ventures looks for next big IT entrepreneurs 2New Madison VC firm Badger Ventures looks for next big IT entrepreneurs 3Vector Surgical hopes to turn frustration into faster surgeries 2Vector Surgical hopes to turn frustration into faster surgeries 3
(Date:8/20/2008)...iction and Mental Health (CAMH) is proud to announ...ada Foundation for Innovation (CFI) into research ...treatment and prevention of mental illness and add...funding from the Large-Scale Institutional Endeavo... allow CAMH to leverage our scientific strengths, ...
(Date:8/19/2008)...vel gonadotrophs , Although the basic developm...it has been harder to associate specific changes i...ed cell population. In an article on p. 546 of the... , Feng et al. take the approach of comparing the ...at were immortalized at different stages of develo...
(Date:8/19/2008)... 19, 2008 An international team led by NYU Cancer...regulates the formation of cilia, which are found ...ial to normal cell function. , The new report,...elected as the featured publication of the open-ac...work together to regulate the formation of primary...
(Date:8/19/2008)...19, 2008 -- Elsevier, a leading global healthcare ...inalists in The Elsevier Grand Challenge, a compet...pe tools innovating how Life Sciences information ...lists were chosen by a distinguished panel of judg... range of approaches involving semantics, visualiz...
Breaking Biology News(10 mins):Large-scale investment catapults CAMH's mental illness and addiction research forward 2September 2008 Biology of Reproduction highlights 2NYU scientists identify critical protein complex in formation of cell cilia 2Elsevier announces 10 semi-finalists for the Elsevier Grand Challenge 2Elsevier announces 10 semi-finalists for the Elsevier Grand Challenge 3Meeting Expectations Named to First Annual CMI 25 List by Corporate Meetings 26 Incentives Magazine 1136 1Meeting Expectations Named to First Annual CMI 25 List by Corporate Meetings 26 Incentives Magazine 1136 2Shopko Express Coming to the Fox Valley 1133 1Shopko Express Coming to the Fox Valley 1133 2Edwards Lifesciences Grants UC Irvine 245 Million to Establish the Edwards Lifesciences Center for Advanced Cardiovascular Technology 537 1Edwards Lifesciences Grants UC Irvine 245 Million to Establish the Edwards Lifesciences Center for Advanced Cardiovascular Technology 537 2Gen Probe to Webcast Presentation at Bank of Americas 37th Annual Investment Conference 534 1Gen Probe to Webcast Presentation at Bank of Americas 37th Annual Investment Conference 534 2
...logists at the University of Texas at Austin uncov... look similar, and it hinges on the way predators ...ans. , In the Mar. 8 issue of Nature, Catherine D...rful frog living in the Amazonian rainforest gets ... poisonous neighbor, but by looking like a frog wh...
... drove themselves to hospital and only 60 per cent...d in the latest Journal of Advanced Nursing. , T...s admitted to six major teaching hospitals in Dubl...n five times as long as men to go to casualty depa...ly one per cent got behind the wheel and drove to ...
...are leading causes of cancer death worldwide, earl... a new scientific study, researchers present aston...g, may have the capacity to contribute to the proc...ich will be published in the March 2006 issue of t...by SAGE Publications, researchers reveal scientifi...
... University of Montana, University of California -...vis have shown that a top predator strongly affect...ood web by eating organisms that transport nutrien...ters Aleutian island plant communities by thwartin...y issue of Ecological Monographs. , As any biologi...
Other Biology News:Poison dart frog mimics gain when birds learn to stay away 2Poison dart frog mimics gain when birds learn to stay away 3One in 14 men having a heart attack drive themselves to hospital 2One in 14 men having a heart attack drive themselves to hospital 3Can dogs smell cancer? 2Not just the birds 2Not just the birds 3
...for Optimal Microdissection , CapSure HS and CapS...traction of populations of pure cells from tissue ...icrodissection., Ensure the Integrity of Microdi... All CapSure LCM Caps have a patented transfer fil...
Opticon continuous fluorescence detector; includes optical base, analysis software, computer and monitor (this is an accessory for the DNA Engine thermal cyclers which must be ordered seperately)
... systems are highly sensitive laser confocal syste...e are advanced scanners that meet your expectation...kground level, and optimizing the signal on the bo...ased sensitivity. Results with VersArray ChipReade...
Bio-Plex Manager software, version 3.0, 5 license netshare, is a five-user software package that provides access to data from the Bio-Plex suspension array system from a server. This version does not
Biology Products: