US-based XOMA Corporation (XOMA) has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its IL-1 beta modulating antibody 'gevokizumab' for the treatment of pyoderma gangrenosum (PG). Gevokizumab is a ...
Tags: Orphan Drug, Medicine
Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval of ADCETRIS (brentuximab vedotin) from the Japanese Ministry of Health, Labour and Welfare ...
RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) ("the Company" or "RegeneRx") announced that it has received Orphan Drug designation from U.S. FDA's Office of Orphan Products Development (OOPD) for its drug candidate, Thymosin beta 4 ...
Tags: RegeneRx Biopharmaceuticals, Orphan Drug designation, Thymosin beta 4
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the European Commission has granted orphan drug ...
The US Food and Drug Administration (FDA) has granted orphan drug designation to Conatus Pharmaceuticals' drug candidate emricasan for the treatment of liver transplant patients with reestablished fibrosis to delay the progression to ...
NanoViricides has secured orphan drug designation from the European Medicines Agency (EMA) for its drug candidate DengueCide, for the treatment of dengue and dengue hemorrhagic fever. Dengue fever is a mosquito-borne disease that affects ...
Tags: Nanoviricides Drug
Cornerstone Pharmaceuticals has received the US Food and Drug Administration (FDA) orphan drug designation for its altered energy metabolism directed (AEMD) drug candidate 'CPI-613' for treatment of myelodysplastic syndrome (MDS). MDS is ...
The US Food & Drug Administration (cof Orphan Product Development has granted orphan drug designation for Lumena Pharmaceuticals' LUM001 clinical program. Lumena obtained orphan designation for LUM001 in four rare cholestatic liver ...
Tags: Orphan Drug, Rare Liver Diseases
RNAi therapeutics company Alnylam Pharmaceuticals has obtained additional orphan drug designation from US FDA for a RNAi therapeutic, ALN-AT3, to treat hemophilia A. With the additional approval, orphan drug designation for GalNAc ...
Tags: Alnylam, Orphan Drug
The European Commission has granted orphan drug designation to BrainStorm Cell Therapeutics’ stem cell therapy NurOwn to treat Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease. NurOwn consists of autologous ...
Tags: Orphan Drug, Medicine
La Jolla Pharmaceutical Company has reported a comprehensive net loss attributable to common stockholders of $3.74m, or $0.14 per share, for the second quarter ended on 30 June 2013 compared with $7.77m, or $0.67 per share in 2012. ...
Tags: La Jolla Pharmaceutical, Net Loss
Biopharmaceutical development company Chelsea Therapeutics has announced the US FDA acceptance of Northera (droxidopa) new drug application (NDA) resubmission to treat symptomatic neurogenic orthostatic hypotension (NOH). The company is ...
Stemline Therapeutics' SL-401 has won orphan drug designation from the Food and Drug Administration (FDA) for the treatment of aggressive hematologic malignancy blastic plasmacytoid dendritic cell neoplasm (BPDCN). With an orphan drug ...
Tags: Stemline Therapeutic, Orphan Drug
The US Food and Drug Administration (FDA) has cleared Omeros' investigational new drug application (IND) for OMS824 in Huntington's disease. OMS824 is developed to selectively inhibit phosphodiesterase 10 enzyme that is expressed in areas ...
Tags: Omeros'IND, Medicine
Teva Pharmaceutical and Xenon Pharmaceuticals have announced the FDA orphan drug designation for analgesic XEN402 being developed to treat pain associated with erythromelalgia (EM). The novel chemical entity XEN402 is designed to inhibit ...
Tags: Pharmaceutical, FDA, Orphan Drug