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.

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
Today's Top SOA Links


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:  http://photos.prnewswire.com/prnh/20110414/NY80976LOGO )

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 novonordisk.com.

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 novonordisk-us.com 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.

Web 2.0 Latest News
Cloud computing changed data analytics for good. It enabled companies to drastically decrease resources and architecture previously assigned with business intelligence departments. It also enabled laymen to run advanced business analytics. Cloud was also the architecture of choice for ...
One look at the comments section of an April column on digital marketing in TechCrunch, and it becomes obvious that contributor Samuel Scott, the marketing and communications director for data analytics software firm Logz.io, pushed a few hot buttons with his take on marketing tech. S...
The current version of Angular is Release Candidate 1. This version changed the way how the framework is distributed – it comes as a set of scoped npm packages now. Any imports of the Angular classes will be done from @angular instead of angular2, for example: import {bootstrap} from ...
Are you evaluating a software asset for a potential purchase, investment, decision making for the future, possible termination, etc? Here are some questions to consider. Is this a revenue generating asset? How much revenue does it generate? - Establishing the true business value of a...
If the cloud was once (ever) bleeding edge, now the cloud is sheer necessity for anyone doing anything on the Internet. It has changed the way we architect applications, build IT budgets, grow userbases, even write individual lines of code. As the Internet continues to lambdify, cloud ...
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