To further encourage
orphan drug availability, accompanying market-oriented incentives for
orphan drug development were issued by the Office of Orphan Products Development, under the auspices of FDA (11).
Under the terms of the agreement, Bristol-Myers Squibb asked the UFDA to approve Taxol for the treatment of ovarian cancer, anticipating that the firm would receive exclusive marketing protection under the Federal Government's poorly drafted and much-abused
Orphan Drug Act.
It has been a strategy of pharmaceutical and biotechnology firms to have their compounds designated as
orphan drugs under the provisions of the 1983
Orphan Drug Act, which provide government credit for R&D expenses for an
orphan drug and marketing exclusivity for seven years.
M2 EQUITYBITES-August 8, 2019-US FDA grants
orphan drug designation to Stoke Therapeutics' STK-001
M2 PHARMA-August 8, 2019-US FDA grants
orphan drug designation to Stoke Therapeutics' STK-001
Global Banking News-September 20, 2018-OBI Pharma Inc wins US FDA's
orphan drug designation for OBI-3424 for Acute Lymphoblastic Leukemia
Trovagene, Inc.'s PCM-075 for the treatment of acute myeloid leukemia (AML) was granted an
orphan drug designation by the FDA.
Pluristem Therapeutics announced that the FDA has granted the company an
orphan drug designation for its PLX-R18 cell therapy for the prevention and treatment of acute radiation syndrome, or ARS.
NEW YORK -- Since its passage in 1983, the
Orphan Drug Act--legislation to facilitate development of
orphan drugs, defined as medications for rare conditions such as Huntington's Disease, myoclonus, ALS, Tourette syndrome and muscular dystrophy --has long been considered a success for encouraging the production of hundreds of medications for the Americans suffering from these diseases.
(PSTI) announced that the FDA has designated its PLacental expanded (PLX) cells
orphan drug status for the treatment of aplastic anemia.
NORDIC BUSINESS REPORT-2 November 2009-Norwegian Clavis Pharma's pancreatic cancer treatment gets
orphan drug status in EU(C)1994-2009 M2 COMMUNICATIONS http://www.m2.com
DOR BioPharma, Inc., Ewing, NJ, announced the Therapeutics Goods Administration (TGA) of Australia has designated orBec as an
Orphan Drug for the treatment of patients with gastrointestinal Graft versus Host Disease (GI GvHD) following allogeneic hematopoietic cell transplantation.