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
SYS-CON.TV
Cloud Expo & Virtualization 2009 East
PLATINUM SPONSORS:
IBM
Smarter Business Solutions Through Dynamic Infrastructure
IBM
Smarter Insights: How the CIO Becomes a Hero Again
Microsoft
Windows Azure
GOLD SPONSORS:
Appsense
Why VDI?
CA
Maximizing the Business Value of Virtualization in Enterprise and Cloud Computing Environments
ExactTarget
Messaging in the Cloud - Email, SMS and Voice
Freedom OSS
Stairway to the Cloud
Sun
Sun's Incubation Platform: Helping Startups Serve the Enterprise
POWER PANELS:
Cloud Computing & Enterprise IT: Cost & Operational Benefits
How and Why is a Flexible IT Infrastructure the Key To the Future?
Click For 2008 West
Event Webcasts
BHR Pharma Investigational Traumatic Brain Injury Treatment Receives European Medicines Agency Orphan Medicinal Product Designation
SyNAPSe® Trial Evaluating Intravenous Progesterone Formulation BHR-100 Aims to Bring First-Ever Approved TBI Treatment to Market

HERNDON, Va., Feb. 13, 2013 /PRNewswire/ -- BHR Pharma, LLC announced today the European Medicines Agency (EMA), responsible for evaluating medicines developed for use in the European Union, granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its proprietary intravenous progesterone infusion agent, BHR-100.  The agent currently is being evaluated as a neuroprotective treatment for severe traumatic brain injury (TBI) in the global, Phase III SyNAPSe® clinical trial.

BHR Pharma is sponsoring SyNAPSe with the intent to bring the first-ever approved TBI treatment to market.  The trial currently has 154 participating sites, including U.S. Level 1 and 2 trauma centers, in 21 countries on four continents. 

"Traumatic brain injury or TBI is a global problem that needs a global solution, and with providing an orphan drug designation for BHR-100 in Europe, the EMA acknowledges the importance of supporting the development of this potential treatment in TBI," said Roland Gerritsen van der Hoop, BHR Pharma Chief Medical Officer and Head of Global R&D. "BHR is committed to bringing this first-of-its-kind treatment to market with the hope of demonstrating progress in a condition with no approved therapies."

To qualify for orphan designation in Europe, a medicine must meet the following criteria:

  • The new medicine must be intended for the treatment, prevention or diagnosis of a disease that is life threatening or chronically debilitating;
  • The prevalence of the disease in the EU most not be more than five of every 10,000 people;
  • The new medicine must be of significant potential benefit to those affected by the disease.

In 2009, the U.S. Food and Drug Administration granted BHR-100 an Orphan Drug designation also for treating moderate and severe TBI and placed the drug on Fast Track status designed to accelerate its potential approval.

BHR initiated the SyNAPSe trial in June 2010 with a total enrollment target of 1,180 severe TBI patients. The trial is now more than 75 percent enrolled.  Last month, the SyNAPSe trial's Independent Data and Safety Monitoring Board (DSMB) released its formal interim analysis, concluding no safety issues exist, there was no reason to stop the study for futility and the trial may continue towards its intended completion. Patient enrollment is set to complete in 2013.

About Traumatic Brain Injury (TBI)
TBI is a serious public health problem that affects millions of people worldwide. There are approximately 66,000 deaths attributed annually to TBI in Europe.[1] According to the World Health Organization, traumatic brain injury is the leading cause of death and disability in children and young adults worldwide and is involved in nearly half of all trauma deaths. Despite significant efforts and more than 75 clinical trials over the past 20 years, there is still no approved treatment for TBI.

About BHR Pharma
Founded in January 2008, BHR Pharma, LLC (www.bhr-pharma.com) is a pharmaceutical research and development company located near Washington, DC, USA.  BHR is committed to bringing to market specialty treatments that employ non-oral delivery systems, with an emphasis on unmet and underserved medical needs. The company is a wholly owned subsidiary of Besins Healthcare SA (www.besins-healthcare.com), which markets healthcare products in 93 countries.

[1] Socin et al. JAMA273:22 (1995).

SOURCE BHR Pharma, 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.

Latest Cloud Developer Stories
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things...
up.time, from uptime software, monitors performance, availability and capacity across all servers, virtual machines, applications, IT services, and the network. Proactively find IT system performance issues before they happen, report on total capacity, easily identify troublemake...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation o...
Cloud services provider SherWeb on Tuesday announced that it has acquired ORCS Web Inc., a Windows-based managed hosting provider headquartered in Charlotte, North Carolina. OrcsWeb will continue to operate as a wholly owned SherWeb subsidiary. Other terms of the agreement have n...
Ericsson on Tuesday announced it has entered into an agreement to acquire US-based MetraTech Corp., a provider of metadata-based billing, commerce and settlement solutions uniquely adaptable to multiple business models and industries. The acquisition includes all 140 employees 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

Breaking Cloud Computing News
Inphi Corporation (NYSE: IPHI), a leading provider of high-speed mixed signal semiconductor solution...