Navigation Links
Amsterdam Molecular Therapeutics Announces European Commission Delays Decision on Glybera® Marketing Authorisation and Requests Further Information From the CHMP
Date:1/29/2012

vely work with the European Commission and the EMA to find the best process going forward, not only for Glybera but also for further advanced therapies on their way to patients," said Jörn Aldag, CEO of AMT. "While gaining clarity for the process involving Glybera, we will continue to implement our revised business strategy revealed following the last CHMP decision. This involves moving forward in partnering discussions for several of our gene therapy products, including hemophilia B and GDNF."

AMT's current business plan, organizational structure and financing have been developed on the basis of the current CHMP opinion for Glybera's non-approval. It involved a reduction of its workforce by about 50%. In the event that Glybera could be commercialized in Europe, the Company will evaluate how the opportunity arising from passing this important milestone could be realized most efficiently.

About Glybera®

AMT has developed Glybera as a treatment for patients with the genetic disorder lipoprotein lipase deficiency. LPLD is an orphan disease for which no treatment exists today. The disease is caused by mutations in the LPL gene, resulting in highly decreased or absent activity of LPL protein in patients. This protein is needed in order to break down large fat-carrying particles that circulate in the blood after each meal. When such particles, called chylomicrons, accumulate in the blood, they may obstruct small blood vessels. Excess chylomicrons result in recurrent and severe acute inflammation of the pancreas, called pancreatitis, the most debilitating and life-threatening clinical complication of LPLD. Glybera has orphan drug status in the EU and US.

About Amsterdam Molecular Therapeutics

AMT is a world leader in the development of human gene based therapies. In addition to Glybera, AMT has a product pipeline of several gene therapy products in development for hemophilia B, Duchenne muscular dystrophy, acute interm
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Amsterdam Molecular Therapeutics Receives Orphan Designation in the European Union for Hemophilia B Gene Therapy
2. Amsterdam Molecular Therapeutics Glybera(R) Significantly Reduces the Risk of Pancreatitis in LPLD Patients
3. Amsterdam Molecular Therapeutics Receives Opinion on Glybera(R) Marketing Authorisation Application
4. Pharma and Food Thought Leaders Set to Converge in Amsterdam Next April 2011
5. Amsterdam Molecular Therapeutics Reports Promising Data From Cholesterol Lowering Gene Therapy Study
6. MolecularHealth to Introduce Knowledge-Driven Solutions that Enhance Drug Safety and Enable Molecularly-Guided Treatment Decision Support
7. Molecular Imaging, Inc. Enters Relationship with Dana-Farber Cancer Institute to Expand Luciferase-reporter Cancer Cell Lines for Preclinical in vivo Imaging
8. Quest Diagnostics Launches Simplexa™ Dengue Test in Brazil, First Commercial Molecular Test Approved for Nations Public and Private Health Testing
9. Roche Diagnostics, Cedars-Sinai Medical Center Enter Strategic Alliance for Center to Operate as a Roche Molecular Center of Excellence
10. Pieris Announces Results and Successful Completion of its PRS-050 Anticalin Phase I Trial at AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics Conference
11. GenturaDx to Host Poster Presentation at Association for Molecular Pathology 2011 Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/1/2015)... April 1, 2015 International Isotopes Inc. (OTCQB: ... year ended December 31, 2014.  The Company reports a ... loss, and positive cash flow for the year ended ... in 2014 was approximately $7.5 million compared to approximately ... approximately 10%.  With the exception of the radiological services ...
(Date:4/1/2015)... 2015 LifeScienceIndustryResearch.com announces ... Industry and 2015 Deep Research Report on ... Pharmaceutical category in its database.  ... basic information, including definition, classification, application, industry ... news analysis, etc. Azithromycin Key Manufacturers Analysis ...
(Date:4/1/2015)... -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP ... on the development of oral drug delivery systems, announced ... Glucose Clamp Study. The study will be performed at ... San Antonio and University Health System,s ... Ralph DeFronzo . The glucose clamp is ...
Breaking Medicine Technology:International Isotopes Inc. Announces 2014 Year End Financial Results 2International Isotopes Inc. Announces 2014 Year End Financial Results 3International Isotopes Inc. Announces 2014 Year End Financial Results 4International Isotopes Inc. Announces 2014 Year End Financial Results 5International Isotopes Inc. Announces 2014 Year End Financial Results 6International Isotopes Inc. Announces 2014 Year End Financial Results 7Azithromycin Market & Polypeptide Drug Industry - Global Research Reports 2Azithromycin Market & Polypeptide Drug Industry - Global Research Reports 3Azithromycin Market & Polypeptide Drug Industry - Global Research Reports 4Azithromycin Market & Polypeptide Drug Industry - Global Research Reports 5Oramed Enrolls First Patient in its Glucose Clamp Study for Oral Insulin 2Oramed Enrolls First Patient in its Glucose Clamp Study for Oral Insulin 3
... Reportlinker.com announces that a new market research report is available ... http://www.reportlinker.com/p0324750/Virtual-Pharma.html ... in the pharmaceutical market has slowed – almost to a ... cutting costs in a faltering world economy. ...
... NEW YORK, Nov. 3, 2010 Pfizer Inc. (NYSE: ... public to view and listen to a webcast of ... Primary Care, at the 2010 Annual Credit Suisse Healthcare ... Mountain Standard Time. (Logo: http://photos.prnewswire.com/prnh/20100416/PFIZERLOGO) ...
Cached Medicine Technology:Reportlinker Adds Virtual Pharma 2Reportlinker Adds Virtual Pharma 3Reportlinker Adds Virtual Pharma 4Reportlinker Adds Virtual Pharma 5Reportlinker Adds Virtual Pharma 6
(Date:4/1/2015)... April 01, 2015 EB Medicine, ... Pediatric Emergency Medicine Practice, and Hospital Medicine Practice, ... with AgileMD to provide the content from its ... a mobile application format available on iPhones, iPads ... collaboration with AgileMD to develop mobile applications for ...
(Date:4/1/2015)... 2015 The U.S. Department of Health ... 123,000 patients who are waiting for a lifesaving organ ... surprising statistic. , In the “Play Through ... a PGA TOUR golfer and two-time heart transplant recipient, ... become organ donors. He inspires viewers by reminding ...
(Date:4/1/2015)... Pricing Healthcare has added facilities to its ... to a third of all US states. The new ... Iowa, and the first dedicated eye center in the country in ... also added. , In addition, the site reached a milestone of ... the platform continue to grow across the country. , 1. ...
(Date:4/1/2015)... Amercanex Corporation, today announced that Native Roots ... and will conduct its wholesale business thru Amercanex proprietary ... as one of the oldest and largest dispensaries in ... in 9 locations with plans of expansion to other ... to have Native Roots join Amercanex as they are ...
(Date:4/1/2015)... April 01, 2015 The term “420” is ... p.m.) when a group of California teenagers would regularly get ... started, 420 has since become a short-hand term for cannabis ... something of a national holiday for the marijuana culture. , ... rapidly-growing group of websites that help bring cannabis businesses and ...
Breaking Medicine News(10 mins):Health News:EB Medicine Partners With AgileMD on Mobile Application for Emergency Medicine Clinicians 2Health News:EB Medicine Partners With AgileMD on Mobile Application for Emergency Medicine Clinicians 3Health News:Donate Life America and Genentech have Partnered to Develop the “Play Through with Erik Compton to Donate Life" Public Service Announcement 2Health News:PricingHealthcare.com Adds Facilities in 5 States, Hits 10,000 Monthly Users Milestone 2Health News:PricingHealthcare.com Adds Facilities in 5 States, Hits 10,000 Monthly Users Milestone 3Health News:Amercanex, Native Roots form Exclusive Relationship to facilitate Wholesale Business 2Health News:Amercanex, Native Roots form Exclusive Relationship to facilitate Wholesale Business 3Health News:The WeedLife Network Marks the Marijuana Culture’s 420 Celebrations by Offering Steep Advertising Discounts 2Health News:The WeedLife Network Marks the Marijuana Culture’s 420 Celebrations by Offering Steep Advertising Discounts 3
... PAT System, Tied Directly ... to Increased Production Efficiency, NEW ORLEANS, March ... challenges that couldn,t previously be,solved, Waters Corporation (NYSE: WAT ... on Analytical Chemistry and,Applied Spectroscopy, March 2 - 6, 2008 ...
... Barras of Nederland,Texas, along with her husband and ... because she has developed mesothelioma from,washing and handling ... are represented by Dallas-based Baron & Budd, P.C., ... refinery worker at the,Beaumont DuPont facility between 1957 ...
... Institute of Diabetes and Digestive and Kidney Diseases ... information to raise awareness about diabetes, digestive diseases, ... yet diagnosed with these illnesses. The NIDDK developed ... fairs, workplace health forums, family reunions, and other ...
... 2008) New high-throughput methods are revolutionizing our ... Cold Spring Harbor Protocols ( www.cshprotocols.org/TOCs/toc3_08.dtl ) ... genes on and off. Both methods are freely ... Harbor Protocols ( www.cshprotocols.org ). , Our knowledge ...
... 3 Park Dental, a Twin Cities area,group ... the Minnesota Dental,community for 40-years, announced today that ... separating its practice from its Boston, Massachusetts-based,administrative services ... is the result of the settlement of a ...
... United,States has been fortifying some foods with folic acid (the ... public health effort to prevent neural,tube defects in newborns. The ... down by 30%. But there,s also evidence that the added ... issue of,Harvard Women,s Health Watch., In the early years ...
Cached Medicine News:Health News:Waters UPLC and HDMS Ignite Scientific Ingenuity with New System Solutions at Pittcon 2008 2Health News:Waters UPLC and HDMS Ignite Scientific Ingenuity with New System Solutions at Pittcon 2008 3Health News:Waters UPLC and HDMS Ignite Scientific Ingenuity with New System Solutions at Pittcon 2008 4Health News:Waters UPLC and HDMS Ignite Scientific Ingenuity with New System Solutions at Pittcon 2008 5Health News:Waters UPLC and HDMS Ignite Scientific Ingenuity with New System Solutions at Pittcon 2008 6Health News:Woman Sues DuPont and Asbestos Manufacturers After Developing Mesothelioma From Exposure to Asbestos in Husband's Work Clothes 2Health News:Cold Spring Harbor Protocols features high-throughput methods for analyzing gene activity 2Health News:Park Dental Announces Separation From Its Administrative Service Provider 2Health News:Park Dental Announces Separation From Its Administrative Service Provider 3Health News:Folic Acid in the Food Supply Reduces Birth Defects, but May Cause Extra Cancers, Reports the Harvard Women's Health Watch 2
This blanket is ideal for warming the large child or small adult during upper body surgery....
The torso blanket is designed to affix to the lower abdominal area and cover the upper half of the body....
The fabric is antistatic and non-linting and is both oil and water repellent.These superior blankets are an environmental friendly alternative to disposable blankets....
The fabric is antistatic and non-linting and is both oil and water repellent.These superior blankets are an environmental friendly alternative to disposable blankets....
Medicine Products: