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

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:8/28/2014)... WEST LAFAYETTE, Ind. A new research ... "nanomechanical" properties of tiny structures undergoing stress ... insights to improve designs for microelectronics and ... spectroscopy, reveals information about how heating and ... their mechanical properties. Researchers have discussed the ...
(Date:8/28/2014)... , Aug. 28, 2014 ... a new market research report ... Whole Exome Sequencing ... (Library Preparation, Target Enrichment), by ... by Synthesis), by Application (Cancer, ...
(Date:8/28/2014)... , Aug. 28, 2014  Next month, executives from clinical ... key industry events beginning with Patient-Centered Clinical Trials 2014 ... Boston , September 4-5. Patient recruitment experts ... Aaron Fleishman will share insights on the benefits ... variety of tactics – from media to mobile apps – ...
(Date:8/28/2014)... 2014 Sterlitech is proud to announce ... its stable of products . These additional ... and include membrane filters with surface charges. ... demand for our membrane process testing equipment, and correspondingly, ... sheet membranes,” explains Sterlitech President Mark Spatz. “The ...
Breaking Biology Technology:New analytical technology reveals 'nanomechanical' surface traits 2New analytical technology reveals 'nanomechanical' surface traits 3Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 2Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 3Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 4Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 5Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 6Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 7Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 8Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 9Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 10Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 11Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 12Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 13BBK Worldwide Leads Sessions at Key September Events 2Sterlitech Corporation Enhances Its Selection of Flat Sheet Membrane Filters 2
... Two UK companies have been awarded joint funding for ... the quest to aid detection and eradication of Tuberculosis ... (NPL) and Orla Protein Technologies (Orla) have been awarded ... methods for the detection of TB. The ...
... ... if (typeof(lpUnit)==,undefined,) var lpUnit=,PRN,; ... var shortURL = ""; BitlyCB.alertResponse = function(data) { var s ... for (var r in data.results) { first_result = data.results[r]; break; } for (var key in first_result) { //s ...
... 27 ISTA Pharmaceuticals, Inc. (Nasdaq: ... REMURA™ (bromfenac ophthalmic solution for dry eye) Phase ... in the primary endpoint of the objective sign ... The study also achieved statistical significance on the ...
Cached Biology Technology:Nanobiotechnology experts join forces to improve TB testing 2Christopher Bowe Joins Scrip as US Healthcare Analyst 2Christopher Bowe Joins Scrip as US Healthcare Analyst 3Christopher Bowe Joins Scrip as US Healthcare Analyst 4Christopher Bowe Joins Scrip as US Healthcare Analyst 5Christopher Bowe Joins Scrip as US Healthcare Analyst 6Christopher Bowe Joins Scrip as US Healthcare Analyst 7ISTA Pharmaceuticals Highlights Clinical Data from REMURA™ Phase 2 Study Presented at the 6th International Conference on the Tear Film & Ocular Surface 2ISTA Pharmaceuticals Highlights Clinical Data from REMURA™ Phase 2 Study Presented at the 6th International Conference on the Tear Film & Ocular Surface 3ISTA Pharmaceuticals Highlights Clinical Data from REMURA™ Phase 2 Study Presented at the 6th International Conference on the Tear Film & Ocular Surface 4
(Date:8/28/2014)... Access to Research Careers) Program has announced the ... Sports Medicine,s Conference on Integrative Physiology of Exercise ... These awards are meant to promote the entry ... groups into the mainstream of the basic science ... scientists at the American College of Sports Medicine,s ...
(Date:8/28/2014)... 28, 2014 Dyslexia, the most commonly diagnosed ... neurological reading disability that occurs when the regions ... function normally. , The use of non-invasive functional ... is disrupted in dyslexia. However, most prior work ... brain regions, leaving a gap in our understanding ...
(Date:8/28/2014)... homes could pose a significant health risk to people with ... Journal of Allergy and Clinical Immunology . , By critically ... the research has found that the presence of several types ... as well as increasing the likelihood of developing the condition. ... the University of Exeter Medical School and is the first ...
Breaking Biology News(10 mins):Dyslexic readers have disrupted network connections in the brain 2Indoor mold poses health risk to asthma sufferers 2
... More than 2,000 former football players are suing the National ... to deal with injuries related to concussions more seriously. ... warrants criticism, the NFL isn,t the only player deserving a ... law expert David Orentlicher, who teaches at Indiana University Robert ...
... , Fraunhofer researchers are exhibiting how renewable, biodegradable ... interior design and the packaging industry at this year,s ... 27 (Hall 5.2a, Booth 103). They consist of ... and diatomaceous earth, a material that is procured from ...
... University of Toronto Scarborough researchers gives the best description ... mental illness called Borderline Personality Disorder (BPD), and could ... shows that brain regions that process negative emotions (for ... BPD, while brain regions that would normally help damp ...
Cached Biology News:Fraunhofer shows bio-tiles and heat-resistant biopolymers 2New insights into the 'borderline personality' brain 2
... ,High Quality, Functionally-Validated, Ion Channel Cell Lines ... having a critical role in nerve and ... function in pain, CNS and the heart. ... investigated in therapeutic areas, such as neuropathic ...
Mouse monoclonal antibody raised against a partial recombinant ENTPD5. NCBI Entrez Gene ID = ENTPD5...
... Solution stains proteins in polyacrylamide gel ... >= 8 ng of protein) with ... destaining processes can be performed in ... (20 min), proteins can be seen ...
Mouse monoclonal antibody raised against a partial recombinant PASK. NCBI Entrez Gene ID = PASK...
Biology Products: