Navigation Links
Amsterdam Molecular Therapeutics Receives Opinion on Re-examination of Glybera® Marketing Authorisation Application
Date:10/21/2011

AMSTERDAM, The Netherlands, October 21, 2011 /PRNewswire/ --

Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has maintained its earlier opinion that Glybera (alipogene tiparvovec) is not approvable at this time. The decision was made contrary to the positive recommendation of CHMP Rapporteurs, the Scientific Advisory Group (SAG), an expert panel specifically selected to evaluate clinical results and the science of the product, and the Committee for Advanced Therapies (CAT), which provides guidance on advanced therapeutics such as gene and cell therapy. These expert groups after extensive review and analysis of the data advised the CHMP that Glybera should be approved now under exceptional circumstances. The CHMP Rapporteurs, SAG and the CAT concluded that data from three Glybera clinical trials demonstrated meaningful evidence of clinical efficacy, without any major safety concerns. However, the CHMP is not bound to follow this advice. While AMT carefully reviews the grounds of the CHMP refusal, the Company will focus on strategic advancement of other promising projects in its development pipeline.

"The decision from the CHMP is disappointing particularly because a treatment will now not be available to European patients who suffer from LPLD for whom Glybera is the only therapeutic option. We are encouraged by the validation provided by the CHMP Rapporteurs, Scientific Advisory Group and the Committee for Advanced Therapies regarding our gene therapy platform, indicating that safety is not an issue," said Jörn Aldag, CEO of AMT. "We are evaluating thoroughly and expediently the next steps available to the Company and will provide an update on the future developments of our validated gene therapy pipeline."

On Tuesday October 25, 2011 at 10:00 AM CET, AMT will provide an update on
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. Amsterdam Molecular Therapeutics Reports Half Year Results 2008
2. Amsterdam Molecular Therapeutics Reports Full Year Results 2008
3. Amsterdam Molecular Therapeutics Reports Half Year Results 2009
4. The University of Amsterdam Joins the MetaMiner Metabolic Diseases Project
5. Amsterdam Molecular Therapeutics Reports Full Year Results 2009
6. Amsterdam Molecular Therapeutics Reports Half-Year Results 2010
7. Amsterdam Molecular Therapeutics Successfully Lowers Cholesterol In Vivo With Enhanced Novel MicroRNA AAV Gene Therapy
8. Amsterdam Molecular Therapeutics Appoints Dr. Carlos R. Camozzi as Chief Medical Officer
9. Amsterdam Molecular Therapeutics Files Glybera® European Marketing Application for Re-examination
10. Amsterdam Molecular Therapeutics Reports Half-Year Results 2011
11. Amsterdam Molecular Therapeutics Licenses Additional Novel Gene Therapy Vectors from National Institutes of Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/29/2015)... 2015  Neuralstem, Inc. (NYSE MKT: CUR), a biopharmaceutical ... molecule and cell therapy treatments for central nervous system ... listing on the NASDAQ Capital Market under the symbol ... on the NYSE MKT until the market close on ... is expected to commence on July 13, 2015. ...
(Date:6/29/2015)... ... June 29, 2015 , ... The StampedeCon 2015 ... for the fourth year in a row, will bring top technology professionals to St. ... at the intersection of data and technology. The event is proudly sponsored by DataStax, ...
(Date:6/29/2015)... NEW YORK , June 29, 2015   For ... of life sciences to assess their overall digital maturity ... to show that these companies are not maturing fast ... the healthcare industry in numerous ways overall and customers ... industries in terms of digital customer engagement.  ...
(Date:6/26/2015)... , June 26, 2015  SeraCare Life Sciences, ... manufacturers, today announced that it has signed a ... National Cancer Institute (NCI), part of the National ... positive controls for cancer assays.  The CRADA will ... accurately quantitate control DNA biosynthetics spiked into a ...
Breaking Biology Technology:Neuralstem, Inc. Announces Approval for Listing on the NASDAQ Capital Market 2Neuralstem, Inc. Announces Approval for Listing on the NASDAQ Capital Market 3StampedeCon Announces 2015 Agenda 2StampedeCon Announces 2015 Agenda 3Results from Digital Maturity Study Show Pharma Lagging 2Results from Digital Maturity Study Show Pharma Lagging 3Results from Digital Maturity Study Show Pharma Lagging 4SeraCare Life Sciences Signs CRADA with NCI to Advance Cancer Diagnostics 2SeraCare Life Sciences Signs CRADA with NCI to Advance Cancer Diagnostics 3
... BOSTON, March 12 Vical Incorporated (Nasdaq:,VICL) announced ... of its,product development programs on Monday, March 17, ... Conference (Boston -- March 17-20)., About Vical, ... on its,patented DNA delivery technologies for the prevention ...
... 11:00 a.m. ET; 8:00 a.m. PT, VANCOUVER and ... OTC: MGIFF), a clinical-stage developer of drugs for infectious,diseases, ... March 13,2008 at 11:00 a.m. ET (8:00 a.m. PT) ... January 31, 2008 and provide an update on,company activities. ...
... (Nasdaq: IDEV ) today announced the Company will ... Care Conference, on,Tuesday, March 18, 2008 at 1:40 pm ... presentation will be web cast live and may be,accessed ... at, http://www.indevus.com ., About Indevus, Indevus Pharmaceuticals, ...
Cached Biology Technology:Vical to Present at Cowen and Company Health Care Conference 2Indevus Pharmaceuticals to Present at Cowen and Company 28th Annual Health Care Conference 2Indevus Pharmaceuticals to Present at Cowen and Company 28th Annual Health Care Conference 3
(Date:6/17/2015)... HILDEN , Deutschland und GERMANTOWN, Maryland ... Investigator ®   Produktlinie mit ... QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt Prime ... neue STR-Testkits der Produktlinie Investigator ... DNA-Spuren in den Markt eingeführt. Die neuen Kits zur ...
(Date:6/16/2015)... /CNW Telbec/ - handyem Inc. and FlowMetric Diagnostics ... of handyem,s HPC-150 portable flow cytometer within FlowMetric ... unprecedented model of mobile laboratory platform is presented ... Pennsylvania Convention Center, ... to 18 th 2015.  By virtue of ...
(Date:6/15/2015)... -- According to a new market research ... and Hybrid), Technologies (Recognition, IVR, OCR, Pattern & Image ... The Natural Language Processing Market is expected to grow ... the forecast period 2015-2020. Browse 65 ... spread   through 155 P ages and in-depth ...
Breaking Biology News(10 mins):QIAGEN bringt in den USA neue Kits für die forensische DNA-Analyse auf den Markt 2QIAGEN bringt in den USA neue Kits für die forensische DNA-Analyse auf den Markt 3QIAGEN bringt in den USA neue Kits für die forensische DNA-Analyse auf den Markt 4QIAGEN bringt in den USA neue Kits für die forensische DNA-Analyse auf den Markt 5QIAGEN bringt in den USA neue Kits für die forensische DNA-Analyse auf den Markt 6handyem and FlowMetric Diagnostics announce their partnership in the development of Flow Cytometry- Based Solutions in diagnostic capabilities 2handyem and FlowMetric Diagnostics announce their partnership in the development of Flow Cytometry- Based Solutions in diagnostic capabilities 3Natural Language Processing Market Worth $13.4 Billion by 2020 2Natural Language Processing Market Worth $13.4 Billion by 2020 3Natural Language Processing Market Worth $13.4 Billion by 2020 4Natural Language Processing Market Worth $13.4 Billion by 2020 5
... protein that regulates gene expression may play a role in ... psychiatric disease. As reported in the latest issue of ... Bipolar Disorders, levels of SP4 (specificity protein 4) were lower ... from patients with bipolar disorder. The study suggests that normalization ...
... DST Health Solutions , LLC, today announced ... (CCHP) has implemented its PowerMHC® core claims administration platform ... new market requirements and enhance data integration. In addition, ... line service for CCHP, which supports more than 31,000 ...
... of a cellular mechanism linked to the toxicity of ... study, published in Environmental Science & Technology , ... neurological diseases such as Alzheimer,s. "I,m not implying ... Michael Plewa, lead scientist and professor of genetics in ...
Cached Biology News:Gene regulatory protein is reduced in bipolar disorder 2Gene regulatory protein is reduced in bipolar disorder 3DST Health Solutions' Integrated Care Management Suite Improves Care Quality, Population Management of 31,000+ Member Health Plan 2DST Health Solutions' Integrated Care Management Suite Improves Care Quality, Population Management of 31,000+ Member Health Plan 3Research links water disinfection byproducts to adverse health effects 2Research links water disinfection byproducts to adverse health effects 3
Mynox is intended for research use only. Mynox is used for the elimination of Mycoplasma and Acholeplasma in cell and virus cultures, and other biologicals....
Convenient 10X buffer concentrate used to maximize binding to the solid phase in microwell ELISA. Formulated to provide optimal pH and ionic strength for binding of antibodies and some antigens. Co...
... can be used to label ... covalently bound acridinium NHS ester ... presence of hydrogen peroxide. Acridinium ... used as a detection method ...
A trigger solution for Flashlight labeled materials....
Biology Products: