Navigation Links
BHR Pharma Enrolls First Patient in Phase 3 SyNAPSe Traumatic Brain Injury Trial
Date:7/23/2010

>

"This drug has the potential to help a gravely ill population that includes car crash and battlefield injuries and we could not be more pleased to initiate this important trial," said Tom MacAllister, J.D., Ph.D., BHR president and CEO.  "The annual incidence of TBI is higher than breast cancer and HIV/AIDS combined, yet it is largely ignored.  We are proud to lead the efforts to make a difference for these patients and their families."

The leading cause of death and disability in children and young adults worldwide, TBI is involved in nearly half of all trauma deaths.  Traffic accidents account for 40-50 percent of the hospitalizations related to the condition.

BHR was notified in June that the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research had completed its special protocol review and the SyNAPSe trial design and planned analysis adequately address the objectives necessary to support a regulatory submission.  Under the FDA Special Protocol Agreement, BHR will be able to seek marketing approval of BHR-100 without additional pivotal trials, provided the SyNAPSe study results meet specific statistical significance targets and other measures.  The trial is posted on www.clinicaltrials.gov.

Last December, BHR announced that its product had been granted orphan drug status by the FDA Office of Orphan Products Development for early intervention in the treatment of moderate-to-severe closed-head TBI.  The FDA only designates orphan-drug status on novel drugs or biologics that treat a rare disease or condition affecting less than 200,000 A
'/>"/>

SOURCE BHR Pharma, LLC
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Health Outcomes Data Essential to Biopharmaceutical Sales Process
2. Horizon Pharma, Inc. Announces Results of Phase 3 Study of LODOTRA® Demonstrate 12-Month Sustained Efficacy and Safety in Rheumatoid Arthritis
3. Alexza Pharmaceuticals Appoints Joseph L. Turner to Its Board of Directors
4. Poniard Pharmaceuticals Receives NASDAQ Deficiency Notice Related to Minimum Bid Price
5. Bayer HealthCare Pharmaceuticals Supports New Jersey Governors School in the Sciences at Drew University
6. Anadys Pharmaceuticals to Report Second Quarter 2010 Financial Results
7. Lotus Pharmaceuticals Terminates SEDA
8. Patrick J. Zenner Elected to Board of Directors of Par Pharmaceutical Companies, Inc.
9. Huifeng Bio-Pharmaceutical Technology Announces a New Spain Order
10. Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Flomax®
11. Ampio Pharmaceuticals Announces Initiation of Phase II Clinical Trial of Optina™
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... N.C. , Jan. 23, 2015 For the pharmaceutical ... in dealing with payers. Likewise, the importance of the managed ... will only continue to grow as payer formularies and provider ... therapies. At the same time, managed markets leaders ...
(Date:1/23/2015)... 2015 Research and Markets ( http://www.researchandmarkets.com/research/5dh22x/urinary_catheters ) ... Market (Indwelling or Foley Catheters, Intermittent Catheters and Male ... Share, Growth, Trends and Forecast 2014 - 2020" ... present, the global market for urinary catheters is experiencing ...
(Date:1/23/2015)...  MedScope ( www.medscope.org ), the leading provider of medical ... Connected World magazine Connected World Award for its ... be used anywhere, anytime. The nomination was made by ... nominating MedScope, Landon Garner , Director of Marketing ...
Breaking Medicine Technology:As Payer Influence Rises, Pharmaceutical Companies work to Optimize the Managed Markets Function 2Urinary Catheters Market (Indwelling or Foley Catheters, Intermittent Catheters and Male External or Condom Catheters) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Urinary Catheters Market (Indwelling or Foley Catheters, Intermittent Catheters and Male External or Condom Catheters) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3MedScope Nominated by RacoWireless for Prestigious 2015 Connected World Magazine Connected World Award 2
... WEST BEND, Wis., Aug. 8, 2011 Eurofins ... service provider and Spaulding Clinical Research, LLC., US-based, ... Device Manufacturer, announce a joint partnership agreement.  This ... facilitates collaboration on integrated clinical services to engage ...
... Va., Aug. 8, 2011 Science Applications International ... has completed the acquisition of Vitalize Consulting Solutions ... and information technology (IT) services for healthcare enterprises. ... the commercial hospital market that are implementing electronic ...
Cached Medicine Technology:Spaulding Clinical Announces New Joint Partnership for Global Studies with Eurofins Optimed Clinical Research 2SAIC Completes Acquisition of Vitalize Consulting Solutions, Inc. 2
(Date:1/22/2015)... The City of West Hollywood hosted a news conference ... 42nd anniversary of the Supreme Court decision Roe v. Wade, which ... since the Roe vs. Wade decision and the fight to protect ... said City of West Hollywood Councilmember Abbe Land. “We need to ...
(Date:1/22/2015)... January 22, 2015 The Incredible Bulk is ... Pakulski to increase lean muscle by up to 30lbs in ... the attention of HealthyandFitZone.com’s Stan Stevenson, prompting an investigative review. ... is a step-by-step, scientific diet formula that allows the body ...
(Date:1/22/2015)... Juvent Sports ( http://www.juventsports.com ) and David ... Show to bestow a Juvent Sports Achievement award upon ... McKitrick. The award commemorated and congratulated McKitrick for her ... won her first amateur tournament in 1979 and most ...
(Date:1/22/2015)... January 22, 2015 Carinsurancesavings.biz has released a ... death and dismemberment insurance . , Purchasing an accidental ... be very advantageous. This type of rider provides benefits if ... can be considered a lesser form of life insurance. ...
(Date:1/22/2015)... January 22, 2015 IsoComforter, Inc. has introduced ... with patented IsoTube design to treat specific body parts and ... most progressive and easy to use patented cold therapy machine ... sports related orthopedic and muscle injuries. IsoComforter has become ...
Breaking Medicine News(10 mins):Health News:The Incredible Bulk: Review Examining Ben Pakulski’s Brand New Bulking Muscle Building Diet Program Released 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Accidental Death and Dismemberment Insurance Can Be Purchased at Low Prices Online 2Health News:IsoComforter Introduces Best of Class Cold Therapy Product to the Worldwide Market 2
... ... by selecting Sensotech cutting edge wireless monitoring system to monitor its main hospital, ... ... improves safety and regulatory compliance and increases operational efficiency by selecting Sensotech cutting ...
... Department of Health Urges All Pennsylvanians to Get Vaccinated , ... Control and Prevention, or CDC, has allocated a total of ... the state Department of Health said today. , The ... departments, and state health centers. , The Department ...
... role in the multisystem disease tuberous sclerosis complex ... role for enhanced activation of the signaling protein Notch ... or the TSC2 protein. As indicated by Warren Pear, ... commentary, these data provide a rationale for testing whether ...
... up, but they,re there, study finds , MONDAY, Dec. 28 (HealthDay ... the long term, a new study finds. , "There appears to ... by Dr. Johan Arnlov, an associate professor of cardiovascular epidemiology at ... 28 in the journal Circulation . , That assessment is ...
... early stages of Alzheimer,s disease are thought to occur ... memory dysfunction. Evidence suggests that amyloid beta (Aβ) ... little has been understood about Aβ,s effect on the ... short outgrowths of dendrites (extensions of neurons) that relay ...
... , , STERLING, Va., Dec. 28 IceWEB, Inc.(TM) (OTC ... purpose built appliances and building blocks for cloud storage networks, ... GIS (Geographic Information System) server technology to augment their efforts ... "IceWEB is proud to Partner with Canadian Health to assist ...
Cached Medicine News:Health News:New Mexico VA Health Care System Selects Sensotech Wireless Temperature Monitoring System 2Health News:JCI table of contents: Dec. 28, 2009 2Health News:JCI table of contents: Dec. 28, 2009 3Health News:JCI table of contents: Dec. 28, 2009 4Health News:JCI table of contents: Dec. 28, 2009 5Health News:JCI table of contents: Dec. 28, 2009 6Health News:JCI table of contents: Dec. 28, 2009 7Health News:JCI table of contents: Dec. 28, 2009 8Health News:Study Debunks Notion of 'Healthy Obese' Man 2Health News:Study Debunks Notion of 'Healthy Obese' Man 3Health News:How amyloid beta reduces plasticity related to synaptic signaling 2Health News:Canadian Health Organization Deploys IceWEB GIS To Track H1N1 Flu Pandemic 2
... classic designs paired with modern, feminine styling. ... materials including ultra-light titanium to 3-D acetate ... almonds and squares. Three-piece mounts and nylon ... wear collection is the perfect combination of ...
... The new Chanel optical collection, ... elegance dear to Mademoiselle's heart, ... to the quilted effect. Combining ... the sparkle of Strass and ...
... Luxury and professionalism. Glamour and style. Creativity ... Luxottica, two market-leading companies, signed a new ... Gabbana brand was formed in 1985 by ... Stefano Gabbana, who blended sensuality with their ...
... includes three collections - Nike Suns, Nike ... active lifestyle consumers the latest vision technology ... sun collections feature Nikes Max Lens technology ... larger vision sweet spot for optimal sport ...
Medicine Products: