Funds for research through Orphan Products
Grants Programs benefit from a 50% deduction tax credit for clinical trial expenses (9) and a market exclusivity of 7 years.
Since its creation in 1983, the Orphan Products
Clinical Trials Grants Program has provided more than $370 million to fund more than 590 new clinical studies and supported the marketing approval of more than 55 products.
Cote rejoin the FDA as the new head of the Orphan Products
Development office," said Janet Woodcock, M.D.
1379 will fortify the ORD by making it a permanent office at NIH; giving it statutory authority which will allow it to form its own research agenda; doubling its budget to $4 million in Fiscal Year 2002 and "such sums as may be necessary" for each subsequent fiscal year; authorizing new funds for Rare Disease Research Centers of Excellence in the amount of $20 million; and doubling the funding of the Orphan Product
Research Grant Program at the FDA-which receives 100 grant applications yearly-to $25 million in FY 2002.
- Israeli clinical-stage company Ayala Pharmaceuticals has been granted Orphan Drug Designation from the US Food and Drug Administration's Office of Orphan Products
Development for AL101, a potent and selective inhibitor of gamma secretase-mediated Notch signalling, for the treatment of ACC, the company said.
Fibrocell Science announced that the FDA office of orphan products
development, or OOPD has awarded a $1.4M clinical trial research grant for Fibrocell's continued clinical development of FCX-007, the company's gene therapy candidate for the treatment of recessive dystrophic epidermolysis bullosa, or RDEB, a rare skin blistering disease with high mortality.
Biopharmaceutical company Stealth BioTherapeutics revealed on Monday the receipt of the US Food and Drug Administration (FDA) Office of Orphan Products
Development's orphan drug designation for investigational drug candidate, elamipretide, for the treatment of Leber's hereditary optic neuropathy (LHON).
This will be the first time the FDA will provide funding through its Orphan Products
Grants to conduct these types of studies for rare diseases.
are developed to treat rare diseases or conditions that affect fewer than 200,000 people in the U.S.
The French Ministry of Research is backing orphan products
research through national programmes covering genome research with funding of over Euro 30 million per year.German legislation provides for the rapid authorisation of medicines of great therapeutic value, with simplified procedures where the treatment is in the public interest, and the federal Government's new health research programme include creation of a national network for groups of rare diseases.
Techniclone Corporation (Nasdaq:TCLN), Tustin, Calif., a developer of leading-edge unique therapeutics for the advanced treatment of cancer, has announced that the Office of Orphan Products
Development of the FDA has determined that Oncolym qualifies for orphan designation for the treatment of intermediate and high-grade B-Cell Non-Hodgkin's Lymphoma.
According to a report recently released by the Pharmaceutical Manufacturers Association, in cooperation with the Food and Drug Administration's Office of Orphan Products
Development and the National Organization for Rare Disorders, 133 orphan drugs that combat 96 rare diseases are currently being developed.