Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AST-120 for the treatment of Pouchitis.
Jazz Pharmaceuticals, Inc. announced today that it has received orphan drug designation from the FDA for its JZP-8 product candidate for the treatment of recurrent acute repetitive seizures. In December 2007, Jazz Pharmaceuticals dosed the first patient in a Phase II clinical trial of JZP-8.
TransMolecular, Inc., a biotechnology company focused on targeted therapies for cancer, today announced that the FDA has granted Orphan Drug Designation for the non-radiolabeled version of its anti-cancer compound TM601, which is currently entering clinical trials for the treatment of malignant glioma. The company had previously received Orphan designation for the radiolabeled version, 131I-TM601, which recently completed patient enrollment in a Phase 2 clinical trial in glioma and a Phase 1 trial in multiple tumor types.
Fovea Pharmaceuticals SA, which, last December 2007, raised $44M in a Series B financing, today announced that its product, Recombinant human rod-derived cone viability factor (rh-RdCVF), has received designation as Orphan Medicinal Product from the European Commission, following the positive opinion from the European Agency for the Evaluation of Medicinal Products (EMEA) Committee for Orphan Medicinal Product (COMP) for the treatment of retinitis pigmentosa, a genetic disease leading to progressive loss of vision.
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