Navigation Links
Kuvan Receives Priority Review Status From Health Canada
Date:6/10/2009

NOVATO, Calif., June 10 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that it has received notice of priority review status for Kuvan(R) (sapropterin dihydrochloride) as an oral treatment for patients with phenylketonuria (PKU) from Health Canada. Priority review provides for a shortened submission review of 180 days versus the standard twelve months. BioMarin plans to file a marketing application for Kuvan in Canada in the third quarter of 2009, and with priority review status, a decision for marketing approval is expected in the first half of 2010.

"Priority review status from Health Canada marks another milestone in our efforts to commercialize Kuvan worldwide as it is granted for serious, life-threatening or severely debilitating diseases for which no approved medical therapy exists in Canada," said Steve Aselage, Senior Vice President and Chief Business Officer of BioMarin. "Along with our partners Merck Serono and Asubio, we remain dedicated to serving the PKU community and providing a therapeutic option in the management of this disease."

About Kuvan

Kuvan(R) (sapropterin dihydrochloride) Tablets are indicated in the United States to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.

The active ingredient in Kuvan, sapropterin dihydrochloride, is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase (PAH) to metabolize Phe.

Kuvan has received orphan drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Kuvan ha
'/>"/>

SOURCE BioMarin Pharmaceutical Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Exclusive Rights to Kuvan(TM) Data Licensed to Asubio Pharma in Japan
2. Kuvan, Naglazyme and Aldurazyme Data to Be Presented at the 57th Annual Meeting of the American Society of Human Genetics
3. Kuvan Receives Positive Opinion From CHMP for European Approval
4. Kuvan Receives Marketing Approval in the European Union
5. BioMarin Receives Notice of Allowance for Once Daily Dosing Patent for Kuvan
6. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
7. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
8. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
9. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
10. IsoTis Receives FDA Clearance for Accell Family of Products
11. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/3/2015)... 3, 2015 /CNW/- SQI Diagnostics Inc. (TSX:V: SQD), a life ... and products for advanced microarray diagnostics, today announced ...  to its Management team. In his capacity as ... transition from a development stage to a commercially ... the Company,s capital market strategy and to secure ...
(Date:3/3/2015)... , March 3, 2015 Fried, Frank, ... Jeffrey I.D. Lewis has joined the Firm as ... in the New York office. ... trademark matters, as well as other intellectual property and ... attorney, Mr. Lewis represents both plaintiffs and defendants in ...
(Date:3/3/2015)... Calif. , March 3, 2015  Rosa & ... in drug-disease modeling and simulation research, today announced it ... 2015 American Society for Clinical Pharmacology and Therapeutics meeting ... 3-7 2015.   Logo - http://photos.prnewswire.com/prnh/20150302/179058LOGO ... Rosa will present a poster describing a quantitative systems ...
(Date:3/3/2015)... Cambridge Semantics, the leading provider of ... announced that it has been named to KMWorld’s 2015 ... Management.’ , To create the list each year, ... system integrators who identify organizations dedicated to the true ... to the right people at the right time. ...
Breaking Biology Technology:SQI Diagnostics Appoints Chief Financial Officer 2SQI Diagnostics Appoints Chief Financial Officer 3Leading Patent Attorney Jeffrey Lewis Joins Fried Frank's Intellectual Property Litigation Practice 2Leading Patent Attorney Jeffrey Lewis Joins Fried Frank's Intellectual Property Litigation Practice 3Rosa & Co. Announces Two Poster Presentations at the American Society for Clinical Pharmacology and Therapeutics 2015 Annual Meeting 2Rosa & Co. Announces Two Poster Presentations at the American Society for Clinical Pharmacology and Therapeutics 2015 Annual Meeting 3Cambridge Semantics Named to KMWorld’s 2015 ‘100 Companies That Matter in Knowledge Management’ 2
... and ST. PAUL, Minn., Jan. 3 /Xinhua-PRNewswire/ ... premier provider of pharmaceutical R&D,outsourcing services, has ... Laboratory Services, Inc. (AppTec). The acquisition of ... capabilities and expertise,gain a significant U.S. operational ...
... Life Sciences,Holdings, Inc. (Nasdaq: ADLS ), a ... of novel drugs in the,therapeutic areas of infection, ... and participate in a panel discussion during a ... Conference on January 9,2008., (Logo: http://www.newscom.com/cgi-bin/prnh/20050428/CGTH039LOGO ...
... Inc., a fully,integrated critical care biopharmaceutical company, announced ... present at the 26th Annual JPMorgan,Healthcare Conference on ... The,conference will be held January 7-10 at The ... Ikaria Holdings, Inc., Ikaria Holdings, Inc. is ...
Cached Biology Technology:WuXi PharmaTech to Acquire AppTec Laboratory Services, Inc. 2WuXi PharmaTech to Acquire AppTec Laboratory Services, Inc. 3WuXi PharmaTech to Acquire AppTec Laboratory Services, Inc. 4WuXi PharmaTech to Acquire AppTec Laboratory Services, Inc. 5Advanced Life Sciences to Present at Biodefense Session of 26th Annual JPMorgan Healthcare Conference 2
(Date:2/12/2015)... NXT-ID, Inc. (NASDAQ: NXTD ... company focused on the growing mobile commerce market, announced ... DISTRIBUTED METHOD AND SYSTEM TO IMPROVE COLLABORATIVE ... establishes NXT-ID,s position in the emerging "Internet of Things" ... for multiple devices to collaborate with one another to ...
(Date:2/9/2015)... 9, 2015  Lintec of America recently announced an ... nanotube (CNT) macrostructures, including sheets, yarns and ribbons, developed ... Leveraging the vast industrial resources of the global ... , Lintec of America is forming the Nano-Science and ... , focusing on scaling up the manufacturing and commercialization ...
(Date:2/5/2015)... , Jan. 26, 2015   Epic Sciences , a ... today announced that Murali Prahalad , Ph.D., president and ... World Conference (PMWC) 2015: Silicon Valley, which is taking ... View, Calif. on January 26-28, 2015. ... of Age as Biomarkers." Last year, Epic Sciences was a ...
Breaking Biology News(10 mins):NXT-ID Patents Collaborative Services to Enable the "Internet of Things" 2NXT-ID Patents Collaborative Services to Enable the "Internet of Things" 3Lintec announces exclusive license to commercialize innovative carbon nanotube technology from the University of Texas at Dallas 2Lintec announces exclusive license to commercialize innovative carbon nanotube technology from the University of Texas at Dallas 3Lintec announces exclusive license to commercialize innovative carbon nanotube technology from the University of Texas at Dallas 4Epic Sciences to Present at Personalized Medicine World Conference 2015 on the Use of Circulating Tumor Cells as Cancer Biomarkers 2
... identified, characterized and cloned ovarian cancer stem cells and ... source of ovarian cancers recurrence and its resistance to ... more effective and targeted treatment for epithelial ovarian cancer, ... Gil Mor, M.D., associate professor in the Department of ...
... Kirkham Soil Physics Gold Medal was awarded to Donald ... the medal at the Third Kirkham Conference, held February ... of America (SSSA) and the Agronomic Science Foundation (ASF). ... physics and hydrology and is held every four years ...
... to analyzing water quality could help reduce the number ... polluted and diseased water for survival. Writing in a ... and Management, an Inderscience publication, researchers from the University ... quality assessment uses fuzzy logic to combine disparate problems ...
Cached Biology News:Ovarian cancer stem cells identified, characterized 2Inaugural Kirkham Gold Medal presented to expert on soil physics 2Fuzzy logic water quality 2
Phosphorylcholine hapten is conjugated to BSA protein by use of p-diazonium phenylphosphorylcholine....
TAR DNA binding protein...
Cyan Standard is 7-hydroxy-4-trifluoromethylcoumarin...
Endothelin-converting enzyme 1 (EC 3.4.24.71) (ECE-1). [Source:Uniprot/SWISSPROT;Acc:P42892] Antigen: Recombinant Protein Epitope Signature Tag (PrEST)....
Biology Products: