Navigation Links
BioMarin Receives Positive Opinion from European Regulatory Authorities for Expanded Biologics Manufacturing Facility
Date:12/19/2011

NOVATO, Calif., Dec. 19, 2011 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for the company's manufacturing facility expansion in Novato, CA.  Final approval by the EMA is expected in the first quarter of 2012, which would allow for products manufactured at the facility to be distributed in the European Union.  The two Novato facilities will support up to $1.0 billion in revenue for BioMarin's growing enzyme replacement therapy portfolio. 

"We are pleased that the CHMP has recommended a positive opinion for the expanded Novato manufacturing facility on the heels of the FDA approval in late November," stated Jean-Jacques Bienaime, Chief Executive Officer of BioMarin.  "As our commercial products continue to grow and our pipeline advances, this state-of-the-art facility will help support the manufacturing requirements for anticipated peak sales of our commercial products and several of our clinical and pre-clinical programs."

About BioMarinBioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse™ (amifampridine), which has been
'/>"/>

SOURCE BioMarin Pharmaceutical Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Highlights from BioMarins Research & Development Day
2. BioMarin Announces Buy Back of Naglazyme Royalties From Adelaide Health Authority
3. BioMarin Initiates Phase 2 Study for GALNS in Patients Under Five Years of Age With MPS IVA
4. BioMarin Announces FDA Approval of Expanded Biologics Manufacturing Facility
5. BioMarin to Host a Research and Development Day on December 8th
6. BioMarin Announces Third Quarter 2011 Financial Results
7. BioMarin to Present at the UBS Global Life Sciences Conference
8. BioMarin to Present at the Morgan Stanley Global Healthcare Conference
9. BioMarin to Present at the Baird Health Care Conference
10. BioMarin to Present at the Wedbush Life Sciences Conference
11. BioMarin Announces Second Quarter 2011 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... 31, 2015  Seeger Weiss LLP is reporting that on ... warning letter to C.R. Bard, the manufacturer of Inferior ... to correct violations the agency found at two of Bard,s ... the FDA cited them during Inspectional Observations that occurred on ... Tempe, AZ , location and on October 6, ...
(Date:7/31/2015)... , July 31, 2015 The Physician-Patient ... release on July 28, 2015, "Surviving Your Hospital ... Fundraising for Patient Safety." A sentence ... should read: "PPAHS is a member ... on Opioids. For more information on the National Coalition ...
(Date:7/31/2015)... -- Quietly, sedately, Morocco,s pharmaceutical sector is ... industry is strong, with a well-developed base of local ... One place where the quality of Moroccan ... has quietly become the second largest African exporter of ... Indeed, Moroccan pharma companies have been making inroads as ...
Breaking Medicine Technology:Seeger Weiss LLP Reports That The FDA Has Issued A Warning Letter To IVC Filter Manufacturer, C.R. Bard 2Seeger Weiss LLP Reports That The FDA Has Issued A Warning Letter To IVC Filter Manufacturer, C.R. Bard 3PharmaBoardroom Releases New Morocco Pharmaceuticals Report 2PharmaBoardroom Releases New Morocco Pharmaceuticals Report 3
... , LYNBROOK, N.Y., Nov. 24 BioSpecifics Technologies Corp. (Nasdaq: ... collagenase-based products, today announced that BioSpecifics, President, Tom Wegman, will ... Conference on Tuesday, December 1, 2009, at 3:30pm ET at ... A live webcast of the presentation can be accessed under ...
... , , CHICAGO, Nov. 23 Two ... introducing a new era in women,s breast imaging, coupling the ... with the ability to have the full range of digital ... leaves the office. Drs. Ahmed Farag and Joan Werber ...
Cached Medicine Technology:Noted Diagnostic Radiologists Joan Werber, D.O., Ahmed Farag, M.D., C.M., Join Forces to Create Diagnostic Imaging Specialists of Chicago 2
(Date:7/31/2015)... ... ... The 2nd annual Ride to Fight On will start and end near the ... to Fight On is a cycling fundraiser that benefits the West Cancer Center, a ... University of Tennessee Health Science Center. A health and wellness festival featuring food, music, ...
(Date:7/31/2015)... ... July 31, 2015 , ... There’s no better way to enjoy ... comes time to cook the next meal, making July the most appropriate to be ... grilling tips and recipes. , Make the next cookout different than the ones in ...
(Date:7/31/2015)... ... July 31, 2015 , ... Facebook, ... Inc. has re-branded their social media profiles to better connect with the public. ... to communicate, find information, share insights and opinions. The Rally Insurance Group, Inc.’s ...
(Date:7/31/2015)... (PRWEB) , ... July 31, 2015 , ... M3 USA ... excited to launch three new Board Exam Courses. , The additions of Gastroenterology, ... Board Exam Prep from MDLinx makes preparing for the exam easy and painless. ...
(Date:7/31/2015)... Angeles, CA (PRWEB) , ... July 31, 2015 , ... According to the article ... third floor of the Pasadena courthouse was contained and extinguished by the city’s fire department ... was in the building at the time of the fire, and it was a fire ...
Breaking Medicine News(10 mins):Health News:West Cancer Center Announces 2nd Annual Ride to Fight On 2Health News:West Cancer Center Announces 2nd Annual Ride to Fight On 3Health News:King Kullen Honors National Hot Dog and Blueberry Month 2Health News:King Kullen Honors National Hot Dog and Blueberry Month 3Health News:Rally Insurance Group, Inc. Connects to Customers Through Re-branded Social Media Profiles 2Health News:MDLinx Offers Three New Board Exam Prep Courses - Gastroenterology, Pulmonology and Allergy/Immunology 2Health News:MDLinx Offers Three New Board Exam Prep Courses - Gastroenterology, Pulmonology and Allergy/Immunology 3Health News:Article on Recent Pasadena Courtroom Fire Highlights the Effectiveness of Fire Alarm Systems, Says Fire Protection Group Inc 2Health News:Article on Recent Pasadena Courtroom Fire Highlights the Effectiveness of Fire Alarm Systems, Says Fire Protection Group Inc 3
... method to monitor the production and clearance rates of ... brain disorders. // ,Amyloid Beta Peptide ... humans can now be possibly diagnosed with the new ... School of Medicine in St. Louis. ,Media ...
... high-blood pressure are at a higher risk for ... ,In a study released today, "Impaired stress ... in African American youth at risk of hypertension," ... identify youth at risk for deteriorating endothelial function. ...
... Health Minister P. K. Sreemathy has announced in Thiruvananthapuram ... sanctioning 50 MBBS seats //each for medical collages in ... on Thursday, while replying to questions in the Assembly ... with the medical council. She further alleged that though ...
... North America (SANA) has welcomed the new recommendations issued ... eating foods high in fiber and using vegetable-based substitutes, ... trans fat, and cholesterol in the diet are decreased. ... by the AHA, providing fiber, high-quality protein, vitamins and ...
... Recently there has been an increase in the age ... as erectile dysfunction or ED in the scenario. Patients ... the problem. While oral medications for ED, known as ... all men respond equally. Through a series of studies, ...
... appears to be three variations of a human gene ... their susceptibility towards tuberculosis// . Researchers hope that these ... patients infected with the Mycobacterium tuberculosis pathogen develop the ... findings was published in the online edition of the ...
Cached Medicine News:Health News:Abnormal Abeta - Protein Level in Human Brain Trigger Alzheimer's Risk 2Health News:Abnormal Abeta - Protein Level in Human Brain Trigger Alzheimer's Risk 3Health News:Mental Stress Linked To Higher Risk Of Heart Disease 2Health News:Soyfoods Are Ideal For The Heart 2Health News:Non Surgical Medication Drugs Prove To Be Effective In Treating ED 2Health News:Susceptibility Of TB In Humans Might Be Due To Three Human Gene Variants 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: