The US Patent and Trademark Office (USPTO) has granted a patent for the use of Aeterna Zentaris' oral ghrelin agonist, AEZS-130 (EP1572) as a diagnostic test for adult growth hormone deficiency (AGHD). AEZS-130, which has been granted ...
Tags: AEZS-130, growth hormone deficiency, AGHD
Inhaled nitric oxide drug products developer GeNO has received four additional US patents on its proprietary inhaled nitric oxide (NO) generation chemistry and delivery technology, bringing the total number of US patents to sixteen. The ...
Tags: inhaled nitric oxide drug, NO, NO2, GeNO
The European Commission (EC) has granted orphan drug designation to Sunesis Pharmaceuticals' Vosaroxin drug. Vosaroxin is a first-in-class anti-cancer quinolone derivative, (AQD), used for the treatment of acute myeloid leukemia (AML). ...
Tags: vosaroxin, AQD, AML, anti-cancer quinolone derivative
Aerial BioPharma, a biopharmaceutical company, has won FDA orphan drug designation for its narcolepsy drug in development. The issuance of designation from the FDA follows the completion of a Phase IIa study in which N05 demonstrated ...
Takeda Pharmaceutical Company and NPS Pharmaceuticals have announced positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Teduglutide (Revestive) for patients with short bowel syndrome (SBS). Teduglutide, ...
Tags: short bowel syndrome, teduglutide, glucagon-like peptide 2
NewLink Genetics HyperAcute-Pancreas Immunotherapy (algenpantucel-L) has gained European orphan designation. Orphan designation provides NewLink with access to multiple incentives for drug development in EU. Incentives include decreased ...
Tags: algenpantucel-L, NewLink Genetics, HyperAcute-Pancreas Immunotherapy
The US Federal Drug Administration (FDA) has received an application from Sobi for Kineret (anakinra) for the indication of neonatal-onset multisystem inflammatory disease (NOMID). The filing is made under an Orphan Drug Designation for ...
Capstone Therapeutics and LipimetiX have formed LipimetiX Development , a joint venture (JV), to develop drugs that are used to treat indications of lowering blood cholesterol levels. The JV will develop a family of Apo E mimetic peptides ...
Tags: Apolipoprotein E, lipoprotein metabolism, Capstone Therapeutics
The US Food and Drug Administration(FDA)has granted orphan drug designation to Savara Pharmaceuticals'first inhaled antibiotic,designed for the treatment of pulmonary methicillin-resistant Staphylococcus aureus(MRSA)infection in cystic ...
Tags: Orphan Drug, Savara Pharma, FDA, inhaled antibiotic, MRSA
The US Food and Drug Administration (FDA) has accepted GeNO's filing of new drug application (NDA) for GeNOsyl MVG-2000 nitric oxide delivery system. GeNOsyl nitric oxide is a vasodilator which is indicated for the treatment of term and ...
Tags: GeNOsyl nitric oxide, FDA
Clinical-stage biopharmaceutical company OXiGENE's acute myelogenous leukemia (AML) drug candidate, OXi4503, has received FDA orphan drug status. The second-generation anticancer agent with a dual-mechanism vascular disrupting feature ...
The US FDA has granted fast track review to Glenveigh Medical’s Digoxin Immune Fab (DIF), which is being developed as severe preeclampsia therapy. Glenveigh Medical founder and chairman Dr. David Adair said DIF is taking ...
The US FDA has granted fast track status to Soligenix's SGX203 for the treatment of pediatric Crohn's disease. SGX203 contains an active corticosteroid, beclomethasone 17,21-dipropionate (BDP), that targets local inflamed tissue. ...
The European Medicines Agency (EMA) has granted orphan drug status to AlphaCore Pharma's ACP-501 (rhLCAT) to treat familial LCAT deficiency (FLD). FLD causes lipid deposition in eyes, red blood cells and kidneys which can lead to corneal ...
Tags: EMA, orphan drug status, AlphaCore FLD
American biotechnology firm XOMA has obtained orphan drug designation by the US Food & Drug Administration (FDA) for its IL-1 beta modulating antibody 'Gevokizumab', which treats non-infectious intermediate, posterior, pan-uveitis, or ...
Tags: American biotechnology, XOMA, orphan drug, FDA