DOR BioPharma, announced that its program for the development of DOR201 has received for the prevention of acute radiation sickness enteritis ‘Fast Track’by the U.S. Food and Drug Administration .
– ‘There are no FDA approved therapies to prevent acute radiation enteritis disease,’said Christopher J. Schaber, President and Chief Executive Officer of DOR. ‘The FDA’s action in granting fast track designation is an indication of DOR201 the potential for this serious, unmet medical need with over 100,000 patients annually with a risk to tackle. As the program progresses to the development, we look forward to working working with the FDA to potentially accelerate the development and NDA review process, the next step will be the introduction of the FDA Phase 1/2 trial in the first half of 2009 ‘.
Fast Track Designation for DOR201 in the prevention of acute radiation enteritissymptoms usually resolve within 2-6 has stopped has stopped. Radiation enteritis is often not self – limited illness, as over 80 percent of the patients with abdominal radiotherapy receive complain a permanent change in bowel habits.First in Acquires Edinburgh Clinical Research Facility Retrieved from Charles River Laboratories and Forms the quotient Clinical – announced Quotient Bioresearch Limited , a leading supplier of pharmaceutical development service, clinical clinical Charles River Laboratories acquired Edinburgh research institution. These makes which sixth acquisition in around three years to Quotient.
Founded in almost 20 years ago, this Edinburgh clinical entity at in FIH studies. World class facility been Further certification status the Medicines and Healthcare products Regulatory Agency granted in January 2009, shows his advice and capabilities to surveys FIH studies for small molecules and Biologika.
The researchers found out that 27 percent of Internal rigorously follows the guidelines that was the highest value among the various types of doctors. Over 21 percent of Family and primary care physicians were very consistent in the observance to Directive, well as 16 percent of OB-GYNs. The researchers found that recognize that some groups Been more likely on obey that guidelines: doctors younger than 40 years of age, ones who were board-certified, and those part of huge, follow up specialty practices of had..