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Mesothelioma Immunotherapy Vaccine Receives Orphan Drug Designation From FDA, Baron & Budd Reports
2015-04-29 04:58:10| drugdiscoveryonline Home Page
The mesothelioma law firm of Baron & Budd reports the U.S
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PBT2 Recommended For Orphan Designation In Europe
2015-04-29 03:49:41| drugdiscoveryonline Home Page
Prana Biotechnology is pleased to announce the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending designation of PBT2 for the treatment of Huntington disease as an orphan medicinal product to the European Commission (EC)
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Oncolytics Biotech Inc. Announces Filing for Orphan Drug Designation...
2015-04-07 16:18:08| Biotech - Topix.net
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in at any given time.
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Oncolytics Biotech's REOLYSIN receives Orphan Drug Designation for treatment of pancreatic cancer
2015-02-17 15:06:44| Biotech - Topix.net
Oncolytics Biotech Inc. , a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation for its lead product candidate, REOLYSIN, for the treatment of pancreatic cancer. "This is the second indication for which we have received Orphan Drug Designation in the United States," said Dr. Brad Thompson, President and CEO of Oncolytics.
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Oncolytics Biotech submits Orphan Drug Designation for high grade gliomas in pediatric patients
2015-02-09 15:30:43| Biotech - Topix.net
Oncolytics Biotech Inc. today announced that it has submitted an application for Orphan Drug Designation to the U.S. Food and Drug Administration for REOLYSIN for the treatment of high grade gliomas in pediatric patients. Oncolytics has conducted three previous clinical studies in brain cancers including gliomas, and has found that REOLYSIN can infect a variety of brain tumors when delivered intravenously.
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