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

2008 West
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
How Can AJAX Improve Homeland Security?
Beyond Widgets: What a RIA Platform Should Offer
REAs: Rich Enterprise Applications
Click For 2008 Event Webcasts
Top Links You Must Click On

Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee

WASHINGTON, Nov. 8, 2012 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Applications (NDA) for insulin degludec and insulin degludec/insulin aspart.

(Logo: )

At the meeting, the Advisory Committee was asked to discuss the data contained in the NDAs and subsequent submissions regarding the benefits and risks of the products, including a lower rate of hypoglycemia and the potential cardiovascular risk profiles of the two products.

The FDA asked the panel members to vote on whether a cardiovascular outcomes trial should be conducted and whether sufficient safety and efficacy data had been provided to support marketing of insulin degludec and insulin degludec/insulin aspart.

The committee unanimously recommended that a cardiovascular outcomes trial should be conducted and voted 8-4 in favor of approving the products with a post-approval outcomes trial commitment.

"The positive vote from the Advisory Committee marks an important step toward making insulin degludec and insulin degludec/insulin aspart available to adult patients with diabetes in the U.S. We look forward to completing the regulatory process with the agency, including the design of the post-approval cardiovascular outcomes trial," said Alan Moses, global chief medical officer of Novo Nordisk.

The FDA has not informed Novo Nordisk of when it expects to complete its review of the NDAs.

Conference call

On November 9 at 8:30 am CET (Central European Time), corresponding to 2:30 am EST, a conference call for investors will be held. Investors will be able to listen in via a link on the investor section of

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy, and hormone replacement therapy. For more information, visit or follow our news in the US on Twitter: @NovoNordiskUS

SOURCE Novo Nordisk

About PR Newswire
Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Enterprise Open Source Magazine Latest Stories . . .
Using any programming framework to the fullest extent possible first requires an understanding of advanced software architecture concepts. While writing a little client-side JavaScript does not necessarily require as much consideration when designing a scalable software architecture, t...
Developers generally like to share their code, and many of them do so by open sourcing it on GitHub, a social code hosting and collaboration service. Many companies also use GitHub as a convenient place to host both private and public code repositories by creating GitHub organizations ...
Test-driven development (TDD) has been around for a while now. Behavior-driven development (BDD), a comparably recent methodology, emerged from the practice of TDD and could reasonably be called a narrower application of TDD. The TDD process allows a developer to use a failing unit t...
It is no surprise that OpenStack has evolved into a widely adopted cloud management framework. As it hurtles on a trajectory of rapid growth, a new breed of demands are making themselves felt – demands that a mature platform of this nature and scope must satisfy. One such requirement i...
The combined notions of open source and the ‘community contribution’ model of collaborative software application development are, of course, not new. The history of open source is actually traced back to early software exchanges between universities driven by academic principles of kn...
Cloud computing delivers on-demand IT resources that provide businesses flexibility. The challenge is the cost and complexity of cloud security compliance (PCI, HIPAA, FFIEC). Raxak Protect automated cloud security enables cloud apps to be deployed quickly and cost-effectively. Get the...
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 Kinja Digest View Additional SYS-CON Feeds
Publish Your Article! Please send it to editorial(at)!

Advertise on this site! Contact advertising(at)! 201 802-3021

SYS-CON Featured Whitepapers