Comments
yourfanat wrote: I am using another tool for Oracle developers - dbForge Studio for Oracle. This IDE has lots of usefull features, among them: oracle designer, code competion and formatter, query builder, debugger, profiler, erxport/import, reports and many others. The latest version supports Oracle 12C. More information here.
Cloud Expo on Google News

2008 West
DIAMOND SPONSOR:
Data Direct
SOA, WOA and Cloud Computing: The New Frontier for Data Services
PLATINUM SPONSORS:
Red Hat
The Opening of Virtualization
GOLD SPONSORS:
Appsense
User Environment Management – The Third Layer of the Desktop
Cordys
Cloud Computing for Business Agility
EMC
CMIS: A Multi-Vendor Proposal for a Service-Based Content Management Interoperability Standard
Freedom OSS
Practical SOA” Max Yankelevich
Intel
Architecting an Enterprise Service Router (ESR) – A Cost-Effective Way to Scale SOA Across the Enterprise
Sensedia
Return on Assests: Bringing Visibility to your SOA Strategy
Symantec
Managing Hybrid Endpoint Environments
VMWare
Game-Changing Technology for Enterprise Clouds and Applications
Click For 2008 West
Event Webcasts

2008 West
PLATINUM SPONSORS:
Appcelerator
Get ‘Rich’ Quick: Rapid Prototyping for RIA with ZERO Server Code
Keynote Systems
Designing for and Managing Performance in the New Frontier of Rich Internet Applications
GOLD SPONSORS:
ICEsoft
How Can AJAX Improve Homeland Security?
Isomorphic
Beyond Widgets: What a RIA Platform Should Offer
Oracle
REAs: Rich Enterprise Applications
Click For 2008 Event Webcasts
SYS-CON.TV
Top Links You Must Click On


Galapagos opens IND for GLPG0634 in the US

MECHELEN, BELGIUM -- (Marketwire) -- 12/03/12 -- Galapagos NV (EURONEXT BRUSSELS: GLPG) announced today that it has opened its Investigational New Drug application for GLPG0634 with the US Food and Drug Administration.

Galapagos intends to conduct a Phase 1 drug interaction study in the United States, which is expected to be completed in the first quarter of 2013. Acceptance of the IND was based on a review by the FDA of the GLPG0634 data package, including chemical/pharmaceutical data, preclinical data up to the formal 13-week toxicology studies and currently completed clinical studies.

"This is an important step in our clinical development plan for GLPG0634," said Piet Wigerinck, CSO of Galapagos. "The FDA has reviewed all the GLPG0634 pre-clinical and clinical data to date and found these supportive of the conduct of our first clinical trial within the United States. We will follow up with studies in rheumatoid arthritis patients next year, and intend to include US study centers in our Phase 2b program."

About Investigational New Drug (IND) Application

United States Federal law requires a pharmaceutical company to obtain an exemption to ship an experimental drug across state lines, usually to clinical investigators, before a marketing application for the drug has been approved. The IND is the means by which the sponsor technically obtains this exemption. The FDA reviews the IND for safety to assure that research subjects will not be subjected to unreasonable risk. The IND application contains information in three broad areas: animal pharmacology and toxicology studies, clinical protocols and investigator information, and manufacturing information.

About Galapagos

Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is a mid-size clinical stage biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action. The Company is progressing its JAK1 inhibitor GLPG0634, as well as one of the largest pipelines in biotech, with four programs in development and over 30 discovery programs. The Galapagos Group has over 800 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com

This release may contain forward-looking statements, including, without limitation, statements containing the words "believes," "anticipates," "expects," "intends," "plans," "seeks," "estimates," "may," "will," "could," "stands to," and "continues," as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Galapagos NV via Thomson Reuters ONE

[HUG#1661929]

CONTACT

Galapagos NV
Dr Piet Wigerink
Chief Scientific Officer
Tel. +32 477 627103

Elizabeth Goodwin
Director Investor Relations
Tel: +31 6 2291 6240
Email Contact

About Marketwired .
Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Enterprise Open Source Magazine Latest Stories . . .
SYS-CON Events announced today that Grid Dynamics, the leading provider of scalable eCommerce technology solutions, will exhibit at DevOps Summit Silicon Valley, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Grid Dynamics is a le...
Appcore aims to simplify private cloud through Apache CloudStack solutions. Nate Gordon serves as the Des Moines, IA-based company's Director of Technology, in its effort to enhance Apache CloudStack and Citrix CloudPlatform for its customers. We had a few questions for him, and this i...
StackIQ offers a comprehensive software suite that automates the deployment, provisioning, and management of Big Infrastructure. With StackIQ’s software, you can spin up fully configured big data clusters, quickly and consistently — from bare-metal up to the applications layer — and ma...

Unless you have been living under a rock the last year, you have probably heard about Docker. Docker describes itself as an open platform for distributed applications for developers and sysadmins. That sounds great, but why does it matter? Wait, virtualization isn’t new!? Virt...

When I took my operating systems fundamentals course in college I was taught that an operating system provides very specific capabilities that provides users with access compute resources for building and running applications. Over time as networking capabilities and bandwidth increase...
There's fog coming to the world of IT. Some people are calling this "The Cloud." This fog turns everything inside out. It will take your monolithic applications, the guts of which are contained within large bodies of code, and break them apart so that discrete units of functionality a...
Subscribe to the World's Most Powerful Newsletters
Subscribe to Our Rss Feeds & Get Your SYS-CON News Live!
Click to Add our RSS Feeds to the Service of Your Choice:
Google Reader or Homepage Add to My Yahoo! Subscribe with Bloglines Subscribe in NewsGator Online
myFeedster Add to My AOL Subscribe in Rojo Add 'Hugg' to Newsburst from CNET News.com Kinja Digest View Additional SYS-CON Feeds
Publish Your Article! Please send it to editorial(at)sys-con.com!

Advertise on this site! Contact advertising(at)sys-con.com! 201 802-3021




SYS-CON Featured Whitepapers
ADS BY GOOGLE