Navigation Links
EMA Starts Formal Review of Glybera(R) Dossier
Date:1/25/2010

AMSTERDAM, The Netherlands, January 25 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, has reached another important milestone in the official marketing authorisation process for its lead product Glybera(R), AMT's proprietary product for lipoprotein lipase deficiency (LPLD). The submission of the Glybera(R) Marketing Authorisation Application (MAA), announced earlier, has cleared the validation stage with The European Medicines Agency (EMA, formerly known as EMEA). The EMA will now commence its formal review of Glybera(R).

AMT has concluded two clinical studies for LPLD, in Europe and Canada, and long term follow-up from both of these is ongoing, as is a third clinical study in Canada. In these three studies Glybera(R) has shown a sizeable decrease in the incidence of pancreatitis, or acute inflammation of the pancreas, the most debilitating complication of LPLD. In addition, these studies indicate that Glybera(R) has an excellent safety profile.

"The acceptance of the Glybera(R) dossier by EMA is a significant step towards marketing approval for Glybera(R). Moreover, it demonstrates AMT's development capability. A future approval of the MAA for Glybera would fully validate our gene therapy approach and our adeno-associated viral (AAV) vector delivery platform. We believe this step offers hope to many patients, as gene therapy may become the therapeutic approach of choice for inherited disorders" said Jorn Aldag, Chief Executive Officer of AMT.

The EMA formal review will be conducted via the centralised procedure, which is the standard route for all advanced therapies. During 2010, AMT expects to provide further updates on the r
'/>"/>

SOURCE Amsterdam Molecular Therapeutics B.V
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related biology technology :

1. KBI Biopharma Starts Cell Line Generation Process under Vendor Network Agreement for PER.C6(R)
2. AMT Starts Preregistration Trial for Glybera(TM)
3. Pierre Fabre Dermatologie Starts Clinical Trials on a Beta-Blocker to Treat Severe Infantile Haemangioma
4. BioCis Pharma Starts Phase IIa Trial in Psoriasis
5. The Pittsburgh Life Sciences Greenhouse Starts 2009 With Investment Momentum
6. China Sky One Medical, Inc. Starts Production at Newly Acquired Facility and Reaffirms Guidance
7. Oncolytics Biotech Inc. Starts Patient Enrolment in U.S. Phase 2 Clinical Trial Investigating REOLYSIN(R) in Combination with Paclitaxel and Carboplatin
8. Gerresheimer Starts Process to Sell off its Business Segment of Technical Plastics
9. Roche starts acquisition process of ARIUS to gain access to new screening platform for antibody therapeutics
10. AMT Starts Collaboration With St. Jude Childrens Research Hospital on Gene Therapy for Hemophilia B. Company Accesses Exclusive Commercial Rights to Final Therapy
11. Anesiva Launches Needle-Free Zingo(TM) to Reduce Pain from IV Starts and Blood Draws in Children
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... Mississauga, Ontario (PRWEB) May 21, 2013 ... expert scientists of the ITN to design the ... usefulness of two key clinical models used in ... Chamber (EEC) and Nasal Allergen Challenge (NAC) models. ... supported by numerous publications, to date no direct ...
(Date:5/21/2013)... May 21, 2013 The Formulate Fusion ... solution for sales and marketing teams looking for a fully-functional ... the kit as “everything you’ll need to put together a ... Kit comes with a number of displays and accessories that ... 20 feet by 20 feet in size. These components vary ...
(Date:5/20/2013)... , May 20, 2013  MiMedx Group, Inc. ... and marketer of patent protected regenerative biomaterials and bioimplants ... has secured a revolving line of credit with Bank ... is secured by the Company,s accounts receivable and inventory, ... May 1, 2014.  The facility will be used for ...
(Date:5/20/2013)... May 20, 2013 With bed bugs' presence ... that although bed bugs need to be eliminated, one must ... compromise a person's health. And so to help bed bug ... get rid of bed bugs without using harmful ... bug spray it called Bed Bug Bully. , According to ...
Breaking Biology Technology:Inflamax Research selected by the Immune Tolerance Network and the National Institutes of Health to conduct a landmark clinical study on the underlying mechanisms of allergic inflammation. 2GLM Displays Announces All-in-One Formulate Fusion Fabric Display Kit 2New Non Pesticide Discovery on How to Get Rid of Bed Bugs Tipped by My Cleaning Products 2
... of how business is conducted today, how important is ... ,Important enough that the expectations bar has been raised ... in recent years with the number of costly or ... in importance. But IT failures are just the tip ...
... the seventh in a series of articles on developing start-up ... article focused on business taxes. , , ... are ready to begin hiring workers. As discussed in the ... taxes, Social Security and Medicare taxes, ...
... . - Third Wave Technologies of Madison has ... lawsuit brought against it by Digene Corp . , ... for the Western District of Wisconsin in Madison, where ... includes counterclaims against Digene, alleging that it has abused its ...
Cached Biology Technology:Fusion 2007: CEOs say bar is raised for CIOs 2Fusion 2007: CEOs say bar is raised for CIOs 3Fusion 2007: CEOs say bar is raised for CIOs 4Early Stage 7, Part I: Just what is an employee? 2Early Stage 7, Part I: Just what is an employee? 3Early Stage 7, Part I: Just what is an employee? 4Early Stage 7, Part I: Just what is an employee? 5
(Date:5/21/2013)... new University of Michigan Water Center today awarded ... Great Lakes restoration and protection efforts. , The ... diverse projects, including efforts to track the remediation ... techniques to control non-native weedy plant invasions; study ... fish responses to restoration activities. , The grants ...
(Date:5/21/2013)... pharmacies and health stores, phosphatidylserine is a natural ... Proven to improve cognition and slow memory loss, ... memory impairment. Now a team headed by Prof. ... Aviv University,s Department of Human Molecular Genetics ... the functioning of genes involved in degenerative brain ...
(Date:5/21/2013)... University of Illinois at Chicago College of Medicine will study ... -- its main energy source -- and how changes in ... new $2 million, 4-year grant from the National Heart, Lung ... it uses fuel for energy. These changes may play a ... different in men and women, says E. Douglas Lewandowski, director ...
Breaking Biology News(10 mins):U-M Water Center awards $570K in Great Lakes restoration grants 2U-M Water Center awards $570K in Great Lakes restoration grants 3U-M Water Center awards $570K in Great Lakes restoration grants 4Common food supplement fights degenerative brain disorders 2Do men's and women's hearts burn fuel differently? 2
... this time of global change, understanding the basics ... as important as predicting and planning for widespread ... animal behaviorsuch as plant toxin detection in bushbaby ... of native lizards to red imported fire ant ...
... WI, August 2nd, 2010 Scientists demonstrate that biochar, ... capture and store carbon, can reduce emissions of nitrous ... from agriculture settings. The finding will help develop strategies ... reduce agriculture,s influence on climate change. A research ...
... Bioengineers at the University of Pennsylvania have created ... substrate surfaces on which cells are grown without ... more controlled lab experiments on cellular mechanobiology, an ... how cells sense and respond to mechanical forces ...
Cached Biology News:Ecological scientists assess the fundamentals of animal behavior 2Ecological scientists assess the fundamentals of animal behavior 3Ecological scientists assess the fundamentals of animal behavior 4Is biochar the answer for ag? 2Mechanical regulation of cell substrates effects stem cell development, adhesion 2
Mouse polyclonal antibody to BTG2 - BTG family, member 2...
...
... used to quantitate double-stranded DNA (dsDNA) in solution, ... With this kit, DNA is stained with Hoechst ... VersaFluor or other fluorometer. The kit quantitates dsDNA ... to 5 micrograms per ml and contains Hoechst ...
... Source of colony stimulating factors for ... marrow, spleen, blood and fetal liver. ... CFU-M, CFU-G and CFU-GEMM when added to ... with addition of erythropoietin. Will also ...
Biology Products: