Navigation Links
OneWorld Health drug receives 'Orphan' designation from U.S. and European regulatory agencies

The Institute for OneWorld Health, the first nonprofit pharmaceutical company in the U.S., announced today it has received Orphan Drug Designation from the two leading regulatory agencies in the world, the Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA), for paromomycin to treat visceral leishmaniasis (VL).

VL, also known as kala azar ("black fever"), is a fatal disease transmitted by sand flies, which spread leishmania parasites that attack internal organs. An estimated 1.5 million people worldwide are currently infected; the number of new VL cases per year is estimated at 500,000; and as many as 200,000 people die annually. More than 90 percent of VL cases occur in five countries: India, which bears the greatest disease burden, Bangladesh, Nepal, Sudan, and Brazil.

The U.S. Orphan Drug Act provides for formal protocol assistance when requested by the sponsors of drugs for rare diseases or conditions. The EMEA regulations are similar, and have the added advantage of applying to all 25 members of the European Union. Orphan Drug Designation also provides incentives such as exemption from certain registration fees, and may help pave the way for approvals in other countries.

OneWorld Health will file for approval of paromomycin in India this year where the need is greatest. It will begin the drug approval process with the FDA and/or the EMEA next year.

"We are pleased with the swift, positive responses by the FDA and EMEA agencies," said Victoria Hale, Ph.D., CEO and Founder of OneWorld Health. "By meeting the rigorous standards of either agency, we will be prepared to accelerate approvals in countries that have a critical need to treat VL."

Paromomycin is an off-patent aminoglycoside antibiotic first used in the 1960s and is still marketed in the U.S. as an oral formulation to treat intestinal parasites. The largest-ever Phase III clinical trial for visceral leishmaniasis
'"/>

Source:Institute for OneWorld Health


Page: 1 2

Related biology news :

1. BioMed Central welcomes the new National Institutes of Health public access policy
2. Health costs soar as 60 million Americans classed as obese
3. Going To Extremes To Improve Human Health
4. Patient-choice C-section rate rises 36%: HealthGrades study
5. Grand Challenges in Global Health initiative funds Yale project
6. Health benefits of a Christmas brandy
7. Health of coral reefs detected from orbit
8. Health of Acehnese reefs in the wake of the tsunami shows human impacts more harmful
9. Healthy coral reefs of Madagascar resisting damage from climate change
10. Health Canada approves cold and flu medicine
11. Mailman School of Public Health researchers report blood DNA can be early predictor of liver cancer
Post Your Comments:
(Date:5/17/2013)... proteins in the brain responsible for protecting nerve cells ... increase cell survival. , The discovery, made by researchers ... the EMBO journal with additional comment in ... stroke and other brain diseases. , The research builds ... protein, known as SUMO, responsible for controlling the chemical ...
(Date:5/17/2013)... Dartmouth College study finds human-caused climate change may ... lizards, contradicting a host of recent studies that ... planet. , The findings, which appear in the ... hope for survival of a creature thought to ... that tropical cold-blooded animals, especially forest lizards, will ...
(Date:5/16/2013)... 17, 2013) Illustrating a commitment to the ... Gastroenterological Association (AGA) Research Foundation has announced the ... Fellowship Award recipients. Supported by the National Institute ... this new award helps underrepresented minority students to ... nutrition research. , "By establishing this new award, ...
Breaking Biology News(10 mins):SUMO wrestling cells reveal new protective mechanism target for stroke 2Climate change may have little impact on tropical lizards 2Underrepresented minority students receive fellowships in digestive disease and nutrition research 2
... 18, 2007)Researchers at The University of Texas Medical School ... glucose metabolism and spina bifida. The decade-long study looked ... their children with that birth defect. UT Medical ... take part in glucose metabolism to look for a ...
... 400 grizzly bears are stored at Montana State University, waiting ... Ecosystem. Ranging from pale blond to almost black, the ... is minus-77.8 degrees. Some of the tufts are almost 25 ... a few months to be analyzed at Wildlife Genetics International ...
... Developing fetuses are extremely sensitive to radiation, which ... of screening or treatment for cancer. Now researchers from ... modeling tools that could enable safer, more accurate, and ... for pregnant women. Radiation is a doubled-edged sword: ...
Cached Biology News:UT-Houston's Northrup and colleagues uncover genetic link to spina bifida 2Study of bear hair will reveal genetic diversity of Yellowstone's grizzlies 2Safer, more accurate radiation therapy for expecting mothers 2Safer, more accurate radiation therapy for expecting mothers 3
(Date:5/17/2013)... May 17, 2013 The new Public-Private ... at the association’s recent annual meeting drew praise ... Vice-President Neelie Kroes, who called the action “a huge ... a stimulant to European innovation.” , The Board of ... the new Photonics PPP at its 29 April meeting ...
(Date:5/17/2013)... 17, 2013  Cellular Biomedicine Group (OTCQB: CBMG) ... of the total projected enrollment required for its ... preliminary efficacy of the medical technology haMPC (Human ... (KOA). To date the trial has had no ... Phase I open label clinical research trial for ...
(Date:5/17/2013)...  Insero Health, Inc., a company developing natural compounds ... neurological disorders, is today reporting top-line results from a ... patients with drug-resistant epilepsy.  The data are being presented ... meeting by Dr. Steven Schachter , ... Advisory Board.  In this study, INS001 appeared safe and ...
(Date:5/17/2013)... Frederick, MD (PRWEB) May 17, 2013 ... release of ezColony version 4.1, a versatile refinement ... world-class premier software solution, improves its advanced methodical ... animal facilities with ezColony 4.1. The network-based platform ... to conduct effective research. While continuing to emphasize ...
Breaking Biology Technology:SPIE Joins in Praise for ‘Huge Step Forward’ for Innovation R&D Enabled by Photonics21 Actions 2SPIE Joins in Praise for ‘Huge Step Forward’ for Innovation R&D Enabled by Photonics21 Actions 3Cellular Biomedicine Group Achieves 50% Enrollment Milestone in Phase I Clinical Trial for Knee Osteoarthritis 2Insero Health Reports Positive Data on Phase I Trial of Novel Therapy for Drug-resistant Epilepsy 2RURO Introduces ezColony 4.1 – The Versatile Transgenic Animal Colony Management Software 2
... April 27 Cellectricon, a leading,provider of ... announced,its collaboration with BioFocus DPI, a contract ... screening. BioFocus DPI will utilize,Cellectricon,s Dynaflow(R)HT, a ... increase its electrophysiology-based screening capacity, particularly,for fast ...
... SALEM, Mass., April 27 LaVoie Group, a life ... been selected as investor relations agency of record for ... of LaVoie Group, commented, "Pegasus has the opportunity to ... The Company is changing the standard of care ...
... MISSISSAUGA, ON, April 24 /PRNewswire-FirstCall/ - Vasogen Inc. (NASDAQ: ... will succeed Terrance H. Gregg as Chairman of its Board ... Gregg,s resignation from Vasogen,s Board is due to the requirements ... , Dr. Smith, a Vasogen Board member since 1998, is ...
Cached Biology Technology:Cellectricon and BioFocus DPI Advance High Throughput ion Channel Drug Discovery 2LaVoie Group Adds Bio-Surgery Company, Pegasus Biologics, to Its Life Sciences Agency Roster 2Vasogen Appoints Dr. Eldon Smith Chairman 2Vasogen Appoints Dr. Eldon Smith Chairman 3
XEDAR Antibody...
Pharmalyte, narrow range pH 4.2-4.9, 25 ml. Category: Electrophoresis Systems & Standards & Reagents, Electrophoresis Standards and Reagents, Immobiline for IEF and Carrier Ampholytes....
...
...
Biology Products: