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:7/10/2014)...  Major advances in radiation therapy and radiosurgery ... in a three-day Oncology Summit taking place in ...  Renowned national and international cancer experts from seven countries ... knowledge on modern technologies making treatment for cancer ... The Summit will address a wide spectrum ...
(Date:7/10/2014)... 10, 2014 Integrated Silicon Solution, Inc. (Nasdaq: ... and analog IC solutions, today announced that it will ... 2014, at 7:00 a.m. Pacific Time (10:00 a.m. Eastern ... fiscal 2014 third quarter ended June 30, 2014. ... 1-888-556-4997 before 6:50 a.m. Pacific time on July 24, ...
(Date:7/10/2014)...  Valeant Pharmaceuticals International, Inc. (NYSE: VRX ... the sale to Galderma of all rights to Restylane, ... Valeant for $1.4 billion in cash, pursuant to the ... its acquisition of Galderma. "We are ... a company that is firmly committed to the aesthetic ...
Breaking Medicine Technology:Improving quality and access to advanced cancer care in India and South Asia 2Improving quality and access to advanced cancer care in India and South Asia 3Improving quality and access to advanced cancer care in India and South Asia 4Improving quality and access to advanced cancer care in India and South Asia 5
... organiser UBM Live , a division of UBM ... CPhI Japan events line-up that is set to return ... March, 2012. The Pharmatech Japan event, which focuses on ... veterinary and medical industries, will join the Japan Pharma ...
... Pharmaceuticals, Inc. (Nasdaq: AUXL ) today announced ... Capital Global Healthcare Conference to be held March 13-14, ... Sargent, Vice President, Investor Relations and Corporate Communications, is ... its product pipeline at 8:00 a.m. ET on Tuesday, ...
Cached Medicine Technology:New Pharmatech Event to be Introduced Alongside CPhI and P-MEC Japan 2New Pharmatech Event to be Introduced Alongside CPhI and P-MEC Japan 3Auxilium Pharmaceuticals to Present at the 2012 Barclays Capital Global Healthcare Conference 2Auxilium Pharmaceuticals to Present at the 2012 Barclays Capital Global Healthcare Conference 3Auxilium Pharmaceuticals to Present at the 2012 Barclays Capital Global Healthcare Conference 4
(Date:7/13/2014)... Athletes with a certain genetic make-up are ... to research presented today at the American Orthopaedic Society ... research marks the first of its kind investigating a ... events that occur after a head injury. , ... the (GT)n genotype were four times more likely to ...
(Date:7/13/2014)... Recently, 2014QuinceaneraDresses.com, the distinguished special occasion dress manufacturer ... gorgeous Quinceanera dresses . , In ... outfits is huge. Therefore, 2014QuinceaneraDresses.com is striving to ... released dresses are made according to the latest ... , It is worthy of mention that ...
(Date:7/13/2014)... Recently, MyDressCity.com, one of the most popular suppliers ... released its new range of elegant Quinceanera dresses ... at discounted prices. Worldwide clients can enjoy this special ... company’s online shop, there are plenty of beautiful dresses ... great materials. MyDressCity.com’s hot items are prom gowns, bridesmaid ...
(Date:7/13/2014)... 13, 2014 Epidemiologists forecast an increase ... 6MM, from 8,062 diagnosed incident cases in 2013 to ... Growth Rate (AGR) of 4.35%, during the forecast period. ... of diagnosed incident cases of aGVHD in the 6MM, ... the lowest number of diagnosed incident cases of aGVHD, ...
(Date:7/13/2014)... 13, 2014 A decreased ability to identify ... and Alzheimer,s disease, while examinations of the eye ... associated with Alzheimer,s, in the brain, according to ... at the Alzheimer,s Association International Conference 2014 (AAIC ... studies, the decreased ability to identify odors was ...
Breaking Medicine News(10 mins):Health News:Genetic Factors May Be Responsible for Slowing Concussion Recovery in Athletes 2Health News:2014QuinceaneraDresses.com Releases Its New Quinceanera Dresses 2Health News:Cheap Elegant Quinceanera Dresses Unveiled by MyDressCity.com 2Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 2Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 3Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 4Health News:Smell and eye tests show potential to detect Alzheimer's early 2Health News:Smell and eye tests show potential to detect Alzheimer's early 3Health News:Smell and eye tests show potential to detect Alzheimer's early 4Health News:Smell and eye tests show potential to detect Alzheimer's early 5Health News:Smell and eye tests show potential to detect Alzheimer's early 6Health News:Smell and eye tests show potential to detect Alzheimer's early 7
... Rajasthan High Court issued notice to the state government ... silicosis. ,The public interest litigation (PIL), filed ... pleaded that the labor force needed to be protected ... of the state government and the malpractice of the ...
... $100,000 of their money to help// construct the first modern ... the donation to the Duk Lost Boys Clinic through the ... spring and serve more than 150,000 people. ... "lost boys" of Sudan who is the director of non-profit ...
... governments to join the anti-tuberculosis global plan, which would ... disease has become extremely drug-resistant. ,Ban's message ... on Saturday. The World Health Organization (WHO) recently reported ... of tuberculosis, XDR-TB, which threatens to derail efforts to ...
... An alarming 20 percent of the people availing re-treatment of ... India. According to a leading global health advocacy, India witness ... the eve of the World TB Day, March 24, the ... TB drug resistance is becoming a major threat for several ...
... harmful for pregnant women and may cause degeneration of their ... ,The musculoskeletal system gives human beings and animals the ability ... The cardiovascular system is composed of the heart, blood vessels, ... the blood. ,Doctors often advice women to ...
... Court about its plan to technologically upgrade its forensic ... up all its vacancies to facilitate quick investigation into ... appearing before a bench of Justice T.S. Thakur and ... steps to fill up about 45 vacancies in the ...
Cached Medicine News:Health News:Public Interest Litigation Filed Favoring Mineworkers Against Silicosis 2Health News:Tuberculosis Drug Resistance 'alarming' in India 2Health News:Rohini Forensic Lab to Be Upgraded 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: