Also, this orphan drug
designation for glepaglutide enables the company to have a closer and more frequent dialogue with the FDA throughout its late stage clinical development.
The study also forecasts a relatively stable amount of spending on orphan drugs
as an overall total of drug spending, which contradicts other research and analyses estimating, in some cases, that by 2020 orphan drug
spending would account for 20% of global spending on drugs, excluding generics.
At issue in the Depomed case was whether the FDA's regulations promulgated to implement the Orphan Drug
Act required the regulator to grant "orphan" status for Gralise without proof of its clinical superiority.
This report provides analysis of this sector and includes brands that have gained orphan drug
approval from the FDA, as well as Phase III pipeline candidates that have gained orphan drug
designation from the FDA.
This is Pluristem's second orphan drug
designation from the FDA.
Since the Orphan Drug
Act was passed by Congress in 1982, more than 200 drugs and biological products have been brought to market, Cruzan said.
Biopharmaceutical company Wilson Therapeutics AB (STO:WTX) announced on Friday the grant by the US Food and Drug Administration (FDA) of Orphan Drug
Designation for WTX101 for the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).
The US Food and Drug Administration (FDA) Office of Orphan Product Development has granted orphan drug
designation to Amplyx Pharmaceuticals' lead drug candidate APX001 to treat multiple invasive fungal and mould infections, it was announced yesterday.
The analysis examines the basis for the agency's approval of 135 noncancer "orphan drugs
" (those for rare diseases) since the Orphan Drug
Act was enacted in 1983 to provide incentives to encourage development of treatments for rare diseases.
a privately held drug development company, has announced that the European Agency for the Evaluation of Medicinal Products (EMEA) has granted Orphan Drug
designation to DTI-015 (carmustine, intratumoral), a novel anti-cancer agent designed for direct injection to malignant brain tumors.
These two biologicals/drugs have been designated as orphan drugs
pursuant to the Orphan Drug
Act of 1983.
M2 EQUITYBITES-November 18, 2016-Amplyx Pharmaceuticals' APX001 receives USFDA orphan drug
M2 PHARMA-February 23, 2015-BioGaia's subsidiary granted Orphan Drug
Designation in Europe
WASHINGTON -- Incentives incorporated in the Orphan Drug
Act have helped with the clearance of over 250 such medications over the last two decades, according to the Food and Drug Administration.
has announced that the Committee for Orphan Medical Products of the European Agency for the Evaluation of Medicinal Products (COMP/EMEA) has rendered a positive opinion on the company's application for orphan drug
designation in the European Community for rhASB (recombinant human arylsulfatase B), as enzyme replacement therapy for patients with Mucopolysaccharidosis (MPS) VI.