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
The US Food and Drug Administration (FDA) has granted orphan drug designation to GeNO for use of inhaled nitric oxide (NO) in treatment of persistant pulmonary hypertension of the newborn (PPHN). The orphan drug designation was granted ...
Tags: orphan drug designation, FDA, persistant pulmonary hypertension
Athersys has received FDA orphan drug designation for its proprietary cell therapy, MultiStem, to treat Hurler's syndrome, also known as mucopolysaccharidosis type I or MPS-I. The orphan drug designation provides substantial potential ...
Baxter International's Gammagard liquid 10% [Immune Globulin Infusion (Human)] has got approval from the US Food and Drug Administration (FDA) as a treatment for multifocal motor neuropathy (MMN). Baxter has been given Orphan Drug ...
Tags: Gammagard liquid, FDA, MMN patients
The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has recommended Orphan Drug Designation (ODD) for Erytech Pharma's investigational product Enhoxy. The drug, which is used to treat sickle cell ...
Tags: orphan drug designation, Erytech product, debilitating disease
Arno Therapeutics has received orphan-drug designation for AR-42 to treat neurofibromatosis type 2 (NF2) in the Europe. AR-42 is a broad-spectrum deacetylation inhibitor of both histone and non-histone proteins. The orally ...
Tags: Orphan-Drug designation, inhibitor, AR-42, clinical product
SK Biopharmaceuticals, a South Korean pharmaceutical company, has received orphan drug designation status for carisbamate for the management of patients with infantile spasms (IS). Carisbamate has previously been shown to have ...
REGENX BioSciences has received FDA orphan drug designation for treatment of familial hypercholesterolemia (HoFH) using NAV rAAV8 vectors. The REGENX program consists of a NAV rAAV8 vector expressing a normal copy of the human ...
Tags: orphan drug designation, familial hypercholesterolemia, clinical study