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
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
Today's Top SOA Links

GSK receives FDA approval for raxibacumab anti-toxin for the treatment of inhalational anthrax

LONDON, Dec. 14, 2012 /PRNewswire/ -- GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.

The effectiveness of raxibacumab is based solely on efficacy studies in animal models as it is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax. The safety of raxibacumab has been studied in healthy adult volunteers, however, there have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using modelling based on data in adults. Raxibacumab does not have direct antibacterial activity. Raxibacumab does not cross into the brain and does not prevent or treat anthrax meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs.

"Raxibacumab is an important part of an ongoing collaboration between GSK and the US government to address a range of public health concerns," said Zhi Hong, Senior Vice President and Head of Infectious Diseases, GlaxoSmithKline. "It will be an important addition to the new approaches required to address our critical biodefense needs."

"Human Genome Science began work on raxibacumab in 2001 in response to the anthrax attacks in the United States. Our development program charted new territory in terms of the science and the regulatory pathway and was a result of our successful collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and FDA," said Sally Bolmer, Senior Vice President of Development and Regulatory Affairs at HGS, where the drug was discovered and developed. HGS was recently acquired by GSK.

Raxibacumab is the first monoclonal anti-toxin to be approved for inhalational anthrax. Anthrax is a rare and lethal disease, caused by a toxin producing bacterium. While antibiotics target the anthrax bacteria, raxibacumab offers an additional mechanism by blocking the activity of the anthrax toxin, which plays a key role in the progression of the disease. Raxibacumab demonstrated an improved survival rate over  control in two relevant animal models both in combination with antibiotics and alone.

The safety of raxibacumab has been evaluated in 326 healthy adult volunteers treated with the recommended dose. Infusion reactions were reported in clinical trials including reports of rash, urticaria (hives) and pruritus (itching). If these reactions occur, slow or interrupt raxibacumab infusion and administer appropriate treatment based on the severity of the reaction. Patients should be premedicated with diphenhydramine (an antihistamine) before treatment. The most frequently reported adverse reactions (less than or equal to 1.5%) were rash, pain in an extremity (arms and legs), pruritus (itching) and somnolence.

The recommended adult dosage of raxibacumab is a single dose of 40 mg/kg given intravenously over a period of two hours and 15 minutes. Administer diphenhydramine within an hour of treatment to reduce the risk of infusion reactions. The recommended dose for children is based on weight.

Raxibacumab is not approved or licensed in Europe and currently is not approved in other parts of the world for the treatment or prophylaxis of patients with inhalational anthrax. For Full US Prescribing Information, please visit,

About raxibacumab
Raxibacumab was discovered and developed by Human Genome Sciences (HGS) in conjunction with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS) under contract number HHS010020050006C.  It is now part of GSK's portfolio, following GSK's acquisition of HGS in July 2012.  The development of raxibacumab is the result of a coordinated response to a recognised public health threat and the US government's request for new medical countermeasures in the event of an anthrax attack against the civilian population. The US Government is currently the sole recipient of raxibacumab supplies.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.

SOURCE GlaxoSmithKline plc

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
This is how a typical software product lifecycle works : You gather requirements, build a prototype, detail out the architecture and design, develop the product, test it, deploy the product, handle migration and maintenance and ensure product support. This is a closed loop where the Pr...
Certain CIOs for incomprehensible reasons keep off their cloud transformation projects several key IT disciplines including Enterprise Architecture (EA), IT Service Management (ITSM) and most importantly Project Management. Do they consider them obsolete? useless? irrelevant? ITaaS St...
In today’s pharmaceutical supply chain, counterfeit activity is thriving. As pharma companies have expanded target markets and outsourced production over the last decade, the supply chain has become increasingly global, virtual, and vulnerable. Illicit activity has thrived, and patient...
Intuit uses deep-data analytics to gain a 360-degree view of its TurboTax application's users’ behavior and preferences for rapid applications improvements. The next BriefingsDirect big-data innovation case study highlights how Intuit uses deep-data analytics to gain a 360-degree view...
Here’s the thing: as sure as we’ll have another record-setting year for NFL streaming, you can also be sure that apps will fail and streaming services will go down. Whether you are dabbling in streaming or diving in whole-hog, you need to know what to do to give your users the most rel...
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