Navigation Links
BHR Pharma Files Investigational New Drug Application, Receives Orphan Drug Designation, for Traumatic Brain Injury Treatment
Date:12/8/2009

r biologics that treat a rare disease or condition affecting less than 200,000 Americans. The designation offers a number of incentives to the treatment developer. This includes a seven-year period of U.S. marketing exclusivity if the drug receives marketing authorization by the agency. Funding for clinical studies, study design assistance, waiver of FDA user fees and tax credits are additional potential incentives.

The company plans to request that the treatment be fast tracked during the regulatory approval process.

"Traumatic brain injury is a terrible condition with high rates of mortality and disability, and currently there are no drugs approved for treating these patients," said Tom MacAllister, BHR president and CEO. "We're excited about achieving the IND milestone and believe that the orphan status will help facilitate a development program with the potential to give these patients and their families hope for better quality of life."

About BHR

Founded in January 2008, BHR Pharma, LLC (www.bhr-pharma.com) is a pharmaceutical research and development (R&D) company located near Washington, DC. BHR is committed to bringing to market specialty treatments that employ non-oral delivery systems, with an emphasis on unmet and underserved medical needs.

A wholly owned subsidiary of Besins Healthcare SA (www.besins-healthcare.com), which markets healthcare products in 93 countries, BHR manages all of Besins' global R&D activities. Those activities primarily leverage proprietary parenteral drug formulations, including the Enhanced Hydroalcoholic Gel (EHG(R)) technology pioneered and commercially launched by Besins in 1975.

SOURCE BHR Pharma, LLC


'/>"/>
SOURCE BHR Pharma, LLC
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Anemia and tropical diseases; Is pharmacogenomics ready for the clinic?
2. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
3. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
4. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
5. The Pharma & Life Sciences Best Practice Database: an Industry Resource for Successful Techniques and Performance Benchmarks for Reaching the Top
6. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
7. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
8. National Pharmaceutical Council Announces New Strategic Focus, Search for New Leadership
9. AKELA Pharma Inc. announces positive results for the extension part of its Phase IIb Fentanyl TAIFUN(R) trial
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
11. Innocoll Agrees the Sale of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT and European Sales and Marketing Infrastructure to EUSA Pharma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... Are you tired of having to repeatedly ... allergies or sinus congestion? Fortunately, an inventor from Newmanstown, ... She conceived of Nose Pal to avoid the worry ... public. Since it prevents nasal drip and the constant ... when cooking or working closely with others. What's more, ...
(Date:9/19/2014)... (PRWEB) September 19, 2014 BearCom, ... solutions, today detailed the key role played by ... radios in the healthcare industry. , “In ... patient care – and in emergency situations, can ... between life and death,” said Hugh Johnston, Product ...
(Date:9/19/2014)... NY (PRWEB) September 19, 2014 On ... News at the Platinum PR and Top Places to ... in New York City. Camino received honorable mentions in ... Campaign” — for its work elevating Latina voices in ... incredible organization and be a part of its efforts ...
(Date:9/19/2014)... Hastings and Hastings, a discount accident lawyer in Phoenix, Arizona, ... number of visitors to its new Phoenix personal injury website. ... as well as auto accident cases and slip & fall ... others. Having served the state of Arizona for over 30 ... when it comes to dedicated and focused personal injury legal ...
(Date:9/19/2014)... NJ (PRWEB) September 19, 2014 Visiting ... provider of home health care, hospice and palliative care ... to ring the Opening Bell yesterday at the New ... New Jersey philanthropist and social entrepreneur to care for ... Health Group has always worked to meet the urgent ...
Breaking Medicine News(10 mins):Health News:Nasal Drip Eliminator Invented by InventHelp Client (LCC-218) 2Health News:BearCom Releases Guidelines on Using Two-Way Radios to Improve Communications and Enhance Patient Service in Healthcare 2Health News:BearCom Releases Guidelines on Using Two-Way Radios to Improve Communications and Enhance Patient Service in Healthcare 3Health News:BearCom Releases Guidelines on Using Two-Way Radios to Improve Communications and Enhance Patient Service in Healthcare 4Health News:Camino Public Relations Honored for Raising Latina Voices in National Health Care, Immigration Debates 2Health News:Hastings And Hastings Announces a Record Number of Visitors to Its New Phoenix Personal Injury Website 2Health News:NJ Largest Home Healthcare Not-for-Profit Joins Deutsche Bank to Ring NYSE Opening Bell 2Health News:NJ Largest Home Healthcare Not-for-Profit Joins Deutsche Bank to Ring NYSE Opening Bell 3
... lines, Bihar legislators today resolved to constitute a high-level body ... awareness among the people of the state on the disease. ... moved by state RJD President and national spokesman Abdul Bari ... the Houses of the legislature. , ,The resolution was ...
... can help lessen the intensity of migraines, says a ... //at the University of North Carolina Medical School, studied ... improved their sleep habits had reduced headache frequencies. ... frequency by 29 percent and headache intensity by 40 ...
... The dean of the All India Institute of Medical Sciences ... subjected to humiliation //by "some colleagues and misguided students". ... was offered the post of vice-chancellor of K.G. Medical University ... in view of the prevalent situation (in AIIMS)," said R.C. ...
... the moon walk which will be held at Edinburgh. About 7999 ... star Lorraine Kelly. ,They are going topless wearing decorated ... and the Maggie’s Centre. They will start the walk at midnight ... ,Hence the name Moon Walk was given as it started ...
... Karnataka insist on a HIV certificate from the foreign/NRI ... The Visvesvaraya Technological University (VTU) in Karnataka has over ... has issued strict orders not to ask for HIV ... VTU vice-chancellor said that when our own students are ...
... researchers will be able to re-establish growth of ... deafness//. ,These tiny hairs in the ear are capable of ... sound. Once lost, these hairs could not be replaced ... out of every twenty-four people, across the globe, suffered from ...
Cached Medicine News:Health News:'Humiliated' Dean Contemplates Leaving AIIMS 2Health News:'Humiliated' Dean Contemplates Leaving AIIMS 3
(Date:9/19/2014)... -- UBM Medica US announces that  OncoTherapy ... oncologists and other clinicians gain a better understanding of ... therapies and immunotherapies, discusses some of the latest news ... Every September, Blood Cancer Awareness Month is ... cancers—helping to increase survival rates and improve the quality ...
(Date:9/19/2014)... 19, 2014  Pressure BioSciences, Inc. (OTCQB: PBIO) ... received and approved all parts required to build ... begun to manufacture the new PCT-based instrument system.  ... ready for shipment by mid-October and that additional ... a rate of about one per week thereafter.  ...
(Date:9/19/2014)... , Sept. 19, 2014  Over 200 runners participated ... to Benefit the Radiation Oncology Institute (ROI), hosted by ... Golden Gate Park in San Francisco.  ... , CEO of Radiation Business Solutions, "but at ... raised over $70,000 for the ROI this year. This ...
Breaking Medicine Technology:OncoTherapy Network Highlights National Blood Cancer Awareness Month 2OncoTherapy Network Highlights National Blood Cancer Awareness Month 3OncoTherapy Network Highlights National Blood Cancer Awareness Month 4Pressure BioSciences Announces Completion of the First Phase of Its Commercialization Plan for the Barozyme HT48, the Company's Recently Released High Throughput PCT-based Instrument System 2Pressure BioSciences Announces Completion of the First Phase of Its Commercialization Plan for the Barozyme HT48, the Company's Recently Released High Throughput PCT-based Instrument System 3Fifth Annual 5K Run for the Future to Benefit the Radiation Oncology Institute Breaks Attendance, Donation Records 2Fifth Annual 5K Run for the Future to Benefit the Radiation Oncology Institute Breaks Attendance, Donation Records 3
... DIEGO, June 19 The Australian company Fermiscan,who ... of a new breast cancer,screening test through the ... rate of 69% in detecting breast cancer., ... published in the Journal of the American Medical,Association(1) ...
... 19 iCAD, Inc. (Nasdaq:,ICAD), an industry-leading provider ... of cancer, today announced it has,initiated a clinical ... in partnership with ACR Image Metrix, a subsidiary ... ACR Image Metrix, having completed the,development portion of ...
Cached Medicine Technology:New Australian Technology: Detecting Breast Cancer With Hair 2New Australian Technology: Detecting Breast Cancer With Hair 3New Australian Technology: Detecting Breast Cancer With Hair 4iCAD Initiates Clinical Study of Its Virtual Colonoscopy CAD in Partnership with ACR Image Metrix 2iCAD Initiates Clinical Study of Its Virtual Colonoscopy CAD in Partnership with ACR Image Metrix 3iCAD Initiates Clinical Study of Its Virtual Colonoscopy CAD in Partnership with ACR Image Metrix 4
... believe that the trocar should be a ... precision and speeding the process. So we ... that meets the needs of the most ... - The only trocar that affords the ...
Operate with confidence. Autosuture is advancing the sate of both open and minimally invasive surgery by providing surgical tools that feel right, function right, and facilitate the right outcome eve...
... Many special order products are offered as ... long lengths. The modular instruments may be ... options such as ratchets, insulation and flush ... Mediflex stock. Customer specifications may affect delivery ...
Operate with confidence. Autosuture is advancing the sate of both open and minimally invasive surgery by providing surgical tools that feel right, function right, and facilitate the right outcome eve...
Medicine Products: