The FDA has granted orphan drug designation for Andromeda Biotech's DiaPep277 to treat type 1 diabetes (T1D) patients with residual beta cell function. The orphan drug status offers seven years marketing exclusivity from the time of ...
Tags: DiaPep277, type 1 diabetes, T1D, residual beta cell
CSL Behring has received FDA orphan drug designation for its recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The designation was granted for the treatment and prophylaxis of bleeding episodes in ...
Tags: CSL Behring, rIX-FP, hemophilia B
Threshold Pharmaceutical has received orphan drug designation for TH-302, a cancer drug, from the US FDA. Threshold is presently testing TH-302 along with a commonly used chemotherapeutic agent, doxorubicin, in a late-stage trial to treat ...
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
FDA has designated Stratatech's universal human skin substitute, StrataGraft, as an orphan drug for the treatment of partial and full thickness skin burns. As per the orphan drug status, the company will be able to market StrataGraft once ...
The US Food and Drug Administration (FDA) has cleared Sigma-Tau Pharmaceuticals' topical ophthalmic therapeutic to treat corneal cystine crystals in cystinosis patients. The CYSTARAN 0.44% solution, which is developed in collaboration ...
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
Pluristem Therapeutics, a developer of placenta-based cell therapies, is seeking FDA orphan drug status for its PLacental eXpanded (PLX) cells for the treatment of aplastic anemia. Pluristem earlier received an orphan drug status from the ...
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
US affiliate of Merz Pharma, Merz has acquired Cuvposa (glycopyrrolate) oral solution, the only FDA approved treatment for pediatric chronic severe drooling (sialorrhea) associated with neurologic conditions such as cerebral palsy. ...
Tags: Merz Pharmaceuticals, CP, Cerebral palsy, Cuvposa
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 ...
ChiRhoClin has relaunched an orphan drug product,ChiRhoStim(Human Secretin for Injection)used to diagnose pancreatic cancer and pancreatic exocrine dysfunction. The company has received permission to market the current batch of ...
Tags: ChiRhoClin, Chirhostim Drug, orphan drug product, pancreatic cancer