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


FDA Advisory Committee Recommends Accelerated Approval of Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline

RARITAN, N.J., Nov. 28, 2012 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA), in a unanimous vote (18-0), agreed that the efficacy findings for investigational bedaquiline support the proposed indication for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The committee agreed in a vote of 11-7 that the safety findings supported the proposed indication.

"We are pleased with the committee's recommendation and look forward to working with the FDA to bring this important therapy to patients who suffer from MDR-TB," said Wim Parys, Global Head of Development, Infectious Diseases and Vaccines, Janssen. "The positive recommendation from the FDA advisory committee is an important step toward achieving that goal."

The FDA assigned a Priority Review designation to the New Drug Application (NDA) filed by Janssen in June seeking accelerated approval for bedaquiline. Recommendations and findings from the advisory committee will be considered by the FDA in its review of the NDA for bedaquiline, but the FDA is not bound to follow them.

About the clinical development program
The regulatory submission is supported by 24-week data from the Phase 2 clinical development program.

Bedaquiline was evaluated in two Phase 2 studies in patients with MDR-TB. TMC207-C208 was designed with two independent stages. Stage 1 was a controlled, randomized, exploratory trial in which 47 patients were treated for eight weeks with either bedaquiline or placebo in combination with a standardized background regimen for MDR-TB. In Stage 2, a controlled and randomized superiority trial, 160 patients were treated with either bedaquiline (400 mg once daily for two weeks followed by 200 mg three times a week for 22 weeks) or placebo in combination with a standardized background regimen for MDR-TB. Background therapy was continued for an additional 12 to 18 months. The primary endpoint was time to culture conversion.   

A second single-arm, open-label, Phase 2 study, TMC207-C209, enrolled 233 patients from 11 countries to evaluate the efficacy, safety and tolerability of  bedaquiline in the treatment of MDR-TB. Bedaquiline was dosed 400 mg once daily for two weeks followed by 200 mg three times weekly for 22 weeks in combination with an individualized background regimen for MDR-TB, followed by continued administration of the background regimen for 12 to18 months.

A confirmatory Phase 3 trial, TMC207-C210, is planned for 2013. It is designed as a double-blind study comparing nine months of treatment with bedaquiline versus placebo (both with a background regimen).

About Janssen Research & Development, LLC
Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. For more information about Janssen Research & Development, LLC visit www.janssenrnd.com. Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to address serious unmet medical needs around the world.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of healthcare products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Research & Development, LLC nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments).

Media Contacts:
Pamela Van Houten
Phone: (908) 295-7367
pvanhou5@its.jnj.com

Daniel De Schryver
Phone: +49 (173) 76 89 149
dschryv@its.jnj.com

Investor contacts:
Stan Panasewicz
Phone: (732) 524-2524

Louise Mehrotra
Phone: (732) 524-6491

SOURCE Janssen Research & Development, LLC

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
I had a fun conversation with Mark Van Rijmenam (@VanRijmenam) a couple of weeks ago about cloud computing, Big Data, and the IoT. Mark runs BigData-Startups.com in Den Haag, Netherlands. We were mutually amused that he had chosen the name Think Bigger for his new book just as I had ch...
We are formally announcing the IoT Project Framework at @ThingsExpo Nov 4-6 in Santa Clara, CA. it will feature four overriding goals for the IoT in the year 2040: 1. To reduce poverty & disease 2. To eliminate violence as a way of settling disputes 3. To spur beneficial economic ...
With Octoblu emerging from stealth mode, it seemed like a good idea to talk to a couple of key people there. We were able to do just that with company co-founders Geir Ramleth and Chris Matthieu. Geir Ramleth serves as CEO. He was named to CIO Magazine's Hall of Fame in 2008, and ser...
“Vote early and vote often.” Back in the 1920s and ’30s, when neither election technology nor oversight were as effective as they are today, and the likes of Al Capone were at work gaming the system, this phrase wasn’t a joke. It was a best practice. If you want guaranteed results, wh...
If you listen to the persistent murmur in the market surrounding the Internet of Things right now, you'd believe that it's all about sensors. Sensors and big data. Sensors that monitor everything from entertainment habits to health status to more mundane environmental data about your h...
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