Navigation Links
European Authorities Approve New Manufacturing Facility for Shire's REPLAGAL® (agalsidase alfa)
Date:6/24/2011

DUBLIN and LEXINGTON, Massachusetts, June 24, 2011 /PRNewswire/ --


 

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the European Medicines Agency has approved the purification of REPLAGAL® (agalsidase alfa) drug substance at its new manufacturing facility in Lexington, MA, US.  REPLAGAL, Shire's enzyme replacement therapy for the treatment of Fabry disease is the first product that will be made available to patients from the new facility.

With this approval, the company now has two approved facilities - Alewife, which is located in Cambridge, MA, as well as the new Lexington facility - in which to purify REPLAGAL, thus providing increased manufacturing flexibility. The cell culture portion of the REPLAGAL manufacturing process will continue to be conducted at Alewife.

 "We are pleased that we were able to accelerate the construction and approval of our new manufacturing facility in order to provide rapid access to important therapies for patients in need," said Bill Ciambrone, Senior Vice President of Technical Operations, Shire HGT. "This new facility allows greater flexibility to meet global demand for our products, including REPLAGAL."

Shire reiterated that it has sufficient product inventory to continue to meet the needs of Fabry patients worldwide currently receiving REPLAGAL and that it can meet anticipated additional demand.  The Company is committed to continuing to provide uninterrupted long-term access to the product at the licensed dose.  

In addition to REPLAGAL, Shire anticipates regulatory agency submission of the VPRIV (velaglucerase alfa) manufacturing process at the new Lexington manufacturing facility by the end of 2011.

Notes to editors

SHIRE PLC

Shire's strategic goal is to become the leadin
'/>"/>

SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
2. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2007
3. European Experts Recommend Pregnant and Nursing Women Take More DHA - Every Day
4. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
5. Terumo Heart to Announce Results of European Clinical Trial of DuraHeart(TM) LVAS at European Association of Cardiothoracic Surgeons Meeting in September
6. Threshold Pharmaceuticals Announces Two Presentations on Glufosfamide at the 2007 European Cancer Conference (ECCO)
7. Study Results for Aclidinium Bromide, a Novel Anticholinergic, Presented at European Respiratory Society Annual Congress
8. Life Recovery Systems Receives European CE Mark Approval for Its ThermoSuit(R) System
9. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
10. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
11. Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/18/2014)... , Nov. 18, 2014 Respiratory Motion ... the leading medical device and services providers in ... partner for Respiratory Motion,s innovative respiratory depression monitor, the ... and IMI are working together to connect the clinical ... a long history of bringing innovative medical devices and ...
(Date:11/18/2014)... SAN DIEGO , Nov. 18, 2014 /PRNewswire/ ... biopharmaceutical company that discovers, develops and plans to ... today that it filed an Investigational New Drug ... Administration (FDA) on Friday, November 14, 2014.  ... development of a patented formulation of the currently ...
(Date:11/18/2014)... , Nov. 18, 2014 BioLink 2015, ... Technology Transfer Summit, co-organized by CCCMHPIE ( China ... of Medicines & Health Products), UBM Live and ... 22nd and 23rd, 2015 at Beijing Yizhuang Biomedical Park. ...   This event will gather 200+ ...
Breaking Medicine Technology:Prominent Japanese Med Device Provider to be Respiratory Motion's Exclusive Partner for World's #2 Medical Market 2Prominent Japanese Med Device Provider to be Respiratory Motion's Exclusive Partner for World's #2 Medical Market 3Prominent Japanese Med Device Provider to be Respiratory Motion's Exclusive Partner for World's #2 Medical Market 4HedgePath Pharmaceuticals Files IND Application 2HedgePath Pharmaceuticals Files IND Application 3HedgePath Pharmaceuticals Files IND Application 4BioLink 2015 Will be Held on Jan 22, 2015, with a Focus on Biopharma Industrial Innovation & International Technology Transfer 2BioLink 2015 Will be Held on Jan 22, 2015, with a Focus on Biopharma Industrial Innovation & International Technology Transfer 3
... 9, 2010 PAREXEL International Corporation (Nasdaq: PRXL ... Capital Markets Healthcare Conference in New York.  Josef von Rickenbach, ... on PAREXEL at 1:10 p.m. ET on Tuesday, November 16, ... be available through the "Investors" section of PAREXEL,s website at ...
... Incorporated (Nasdaq: ARAY ), a global leader in the ... of fiscal year 2011, ended September 30, 2010. ... of $38.1 million, a decrease over the first quarter of fiscal ... for the first quarter of fiscal 2011 was $4.6 million, or ...
Cached Medicine Technology:PAREXEL International to Participate in the Lazard Capital Markets Healthcare Conference in New York and the Jefferies Healthcare Summit in Boston 2Accuray Announces Results for First Quarter of Fiscal 2011 2Accuray Announces Results for First Quarter of Fiscal 2011 3Accuray Announces Results for First Quarter of Fiscal 2011 4Accuray Announces Results for First Quarter of Fiscal 2011 5Accuray Announces Results for First Quarter of Fiscal 2011 6
(Date:11/21/2014)... TX (PRWEB) November 21, 2014 ... Benefit Solutions , will present advanced benefits administration ... 6th Annual Houston HR Leadership Summit. This Game ... Human Resources industry to present cutting-edge solutions and ... presentation will explain how real-time data exchange between ...
(Date:11/21/2014)... 2014 Saint Luke’s Mid America ... Guidelines®–Heart Failure Gold-Plus Quality Achievement Award for implementing ... Heart Association/American College of Cardiology Foundation in their ... Get With The Guidelines–Heart Failure is a quality ... most up-to-date, research-based guidelines with the goal of ...
(Date:11/21/2014)... The typical Thanksgiving dinner table is ... of gravy and a myriad of mouthwatering desserts. Who ... of year to begin losing weight? Listen closely. With ... secret to losing unhealthy, embarrassing and uncomfortable fat while ... The insight to Diet Doc’s calorie loading holiday ...
(Date:11/21/2014)... 2014 Midway through the research period ... (AIS) annual Directory of Health Plans, preliminary data shows ... of Health Plans is a comprehensive resource with enrollment ... the U.S. The 2015 edition will be ... Directory and Databases Division, the company’s exclusive in-house research ...
(Date:11/21/2014)... For many busy people, having their missing or damaged teeth ... from dental surgery that have traditionally been required for a ... youthful appearance. , But the dental implant experts ... Hills, Calif., can provide someone with a full mouth of ... patient’s bone has deteriorated. , Dr. Saj Jivraj and Dr. ...
Breaking Medicine News(10 mins):Health News:Empyrean Benefit Solutions CEO Sharing Latest Benefits Administration Strategies with Houston HR Leaders 2Health News:Empyrean Benefit Solutions CEO Sharing Latest Benefits Administration Strategies with Houston HR Leaders 3Health News:Saint Luke’s Mid America Heart Institute Awarded Get With The Guidelines Heart Failure Gold-Plus Quality Achievement Award 2Health News:Saint Luke’s Mid America Heart Institute Awarded Get With The Guidelines Heart Failure Gold-Plus Quality Achievement Award 3Health News:Saint Luke’s Mid America Heart Institute Awarded Get With The Guidelines Heart Failure Gold-Plus Quality Achievement Award 4Health News:Diet Doc Releases New Calorie Loading Diet Plans - the Perfect Way to Jump Start the Metabolism and Begin Weight Loss During Thanksgiving 2Health News:Diet Doc Releases New Calorie Loading Diet Plans - the Perfect Way to Jump Start the Metabolism and Begin Weight Loss During Thanksgiving 3Health News:Diet Doc Releases New Calorie Loading Diet Plans - the Perfect Way to Jump Start the Metabolism and Begin Weight Loss During Thanksgiving 4Health News:Data from Atlantic Information Services’s Forthcoming Directory Shows Volatility in U.S. Health Care Market 2Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 2Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 3Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 4Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 5
... 91% Increase in Earnings for First Half of 2008 ... Metropolitan,Health Networks, Inc. (Amex: MDF ), a ... results for the six months,and quarter ended June 30, ... that in the three months ended,June 30, 2008, the ...
... /Xinhua-PRNewswire/ -- Simcere Pharmaceutical,Group (NYSE: SCR ), a ... of the patented anti-cancer biotech,product Endu in China, today ... 2008., Highlights -- Total revenue increased ... second quarter, representing a 30.4% year-over-year growth;, ...
... Year-over-Year to $10.7 Million Backlog Reaches $72 ... Million ... to Market Recently-introduced Odyssey System Building Strong Market Momentum, ST. ... second quarter ended June,30, 2008. Revenue for the recent second quarter increased 36% ...
... goes for gold and aims to give back to Mercy Ships ... ... Laser Champion and one of Britain,s greatest medal hopes at the Beijing ... charity Mercy Ships which provides free medical care to the people of ...
... major website re-design, aimed specifically toward potential clients, with improved ... ... New York, NY (PRWEB) August 5, 2008 -- ... re-design, aimed specifically toward potential clients, with improved navigability, clear ...
... esignature, Princor representatives now benefit from a more efficient account ... ... Ontario, CA (PRWEB) August 5, 2008 -- Interlink Electronics, Inc. ... Corporation, a member of the Principal Financial Group®. The Princor® ...
Cached Medicine News:Health News:Metropolitan Health Networks Reports 2008 Second Quarter Results 2Health News:Metropolitan Health Networks Reports 2008 Second Quarter Results 3Health News:Metropolitan Health Networks Reports 2008 Second Quarter Results 4Health News:Metropolitan Health Networks Reports 2008 Second Quarter Results 5Health News:Metropolitan Health Networks Reports 2008 Second Quarter Results 6Health News:Metropolitan Health Networks Reports 2008 Second Quarter Results 7Health News:Metropolitan Health Networks Reports 2008 Second Quarter Results 8Health News:Metropolitan Health Networks Reports 2008 Second Quarter Results 9Health News:Metropolitan Health Networks Reports 2008 Second Quarter Results 10Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 2Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 3Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 4Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 5Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 6Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 7Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 8Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 9Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 10Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 11Health News:Simcere Pharmaceutical Group Reports Unaudited Second Quarter 2008 Results 12Health News:Stereotaxis Reports Record Second Quarter Revenue 2Health News:Stereotaxis Reports Record Second Quarter Revenue 3Health News:Stereotaxis Reports Record Second Quarter Revenue 4Health News:Stereotaxis Reports Record Second Quarter Revenue 5Health News:Stereotaxis Reports Record Second Quarter Revenue 6Health News:Stereotaxis Reports Record Second Quarter Revenue 7Health News:Stereotaxis Reports Record Second Quarter Revenue 8Health News:Olympic Sailing Hopeful Backs Hospital Ship Charity 2Health News:Olympic Sailing Hopeful Backs Hospital Ship Charity 3Health News:Olympic Sailing Hopeful Backs Hospital Ship Charity 4Health News:Re-Designed Legal Website Includes Blog 2Health News:Interlink and LaserApp Partnership Provides eSignature-Ready Forms to Princor Financial Services 2Health News:Interlink and LaserApp Partnership Provides eSignature-Ready Forms to Princor Financial Services 3Health News:Interlink and LaserApp Partnership Provides eSignature-Ready Forms to Princor Financial Services 4
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: