BioSante Pharmaceuticals, Inc. has announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA’s Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease that affects almost 200,000 Americans. Orphan drug designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity.

Read the full story here

The U.S. Food and Drug Administration has granted the Orphan Drug Designation to a unique drug for children suffering from Ewing’s Sarcoma cancer developed by the Cure Our Children Foundation. The non profit and charitable organization was successful in development of this drug because of the generous volunteers, doctors in industry and researchers at two universities. The approval facilitates the development of the drug by providing fee waivers, FDA’s assistance for review and other benefits. The new drug is a combination of biotechnology and nanotechnology. Cell matter is modified to have the genetic code of tumor cells. When the cancer cells uptake this matter, they stop reproducing and die.

The U.S. Food and Drug Administration has granted orphan drug designation to Reata Pharmaceuticals, Inc.’s RTA 402 for treating patients suffering from pancreatic cancer. Currently in Phase 1/2 of its trial, RTA 402 receives economic incentive for further development in the form of reduction/exemption in regulatory fees, seven years of exclusivity in market and other support from FDA for R&D initiatives.