Nanoviricides Inc., of West Haven, Conn., filed an orphan drug applicaton with the FDA for Denguecide, its drug candidate for the treatment of dengue and dengue hemorrhagic fever...Stemline Therapeutics Inc., of New York, received orphan drug designation from the FDA for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive hematologic malignancy for which there is no effective treatment

Advaxis Inc., submitted an application for orphan drug designation to the FDA for ADXS-HPV, its lead drug candidate, for the treatment of invasive cervical cancer

Sucampo Pharmaceuticals Inc., of Bethesda, Md., said it received orphan drug designation in Europe for unoprostone isopropyl for the treatment of retinitis pigmentosa

Aradigm has completed Phase IIb trials in noncystic fibrosis bronchiectasis (BE) patients with Pulmaquin and Lipoquin, which have been granted orphan drug designation for BE in the U.S. Under the licensing agreement, Aradigm and Grifols will move the formulations into Phase III trials in BE, with Grifols picking up all development and clinical expenses, up to $65 million

Jennerex Biotherapeutics Inc., of San Francisco, said the FDA granted orphan drug status for Pexa-Vec (JX-594, pexastimogene devacirepvec) for the treatment of hepatocellular carcinoma (HCC

Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer

Hyperion Therapeutics Inc., of South San Francisco, said the FDA notified the firm that Ravicti (glycerol phenylbutyrate) qualified for orphan drug exclusivity, giving the product exclusivity on the market for seven years from the date of approval on Feb. 1

The FDA approved Cystaran in October 2012 and granted the product orphan drug status...On Tuesday, the FDA also approved Raptor Pharmaceutical Corp.'s orphan drug Procysbi (RP103, cysteamine bitartrate delayed-release) to treat the larger indication of nephropathic cystinosis. (See BioWorld Today, May 1, 2013

Xenon Pharmaceuticals Inc., of Burnaby, British Columbia, and Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA has granted orphan drug designation to XEN402 to treat pain associated with erythromelalgia, a rare autosomal dominant condition characterized by burning pain in the feet and hands

portfolio company, received orphan drug status from the FDA for ApoCell, a treatment based on inducing immune tolerance for preventing graft-vs.-host disease

portfolio company, received orphan drug status from the FDA for ApoCell, a treatment based on inducing immune tolerance for preventing graft-vs.-host disease

Insmed Inc., of Monmouth Junction, N.J., said Arikace, its liposomal amikacin for inhalation, received orphan drug designation from the FDA for the treatment of infections caused by nontuberculus mycobacteria (NTM

Plasma-derived C1 esterase inhibitor is an orphan drug approved by the FDA to treat or prevent the symptoms of hereditary angioedema

Cangene Corp., of Winnipeg, Manitoba, said the FDA approved its Botulism Antitoxin (equine), heptavalent (A, B, C, D, E, F, G) (BAT) product for treating suspected or documented exposure to the botulinum neurotoxin A, B, C, D, E, F or G. Cangene's BAT received orphan drug designation and now has seven years of marketing exclusivity

Proteo Inc., of Irvine, Calif., said the FDA granted orphan drug designation to Elafin for the prevention of inflammatory complications of transthoracic esophagectomy

GenSpera Inc., of San Antonio, said the FDA granted orphan drug designation to G-202 for the treatment of hepatocellular carcinoma...ProMetic Life Sciences Inc., of Laval, Quebec, said the FDA granted orphan drug status for its plasma purified human plasminogen drug for use in the treatment of hypoplasminogenemia, or Type I plasminogen deficiency (T1PD

After nearly shuttering in 2009 following the failure of its initial program, in 2011 Adventrx acquired privately held SynthRx Inc., of Houston, and its rheologic and antithrombotic agent, poloxamer (ANX-188), to treat sickle cell crisis in a pediatric population, for which the compound has orphan drug designation

Pluristem Therapeutics Inc., of Haifa, Israel, said its PLacental eXpanded (PLX) cells received FDA orphan drug status in aplastic anemia...The FDA previously granted orphan drug designation to Pluristem's PLX cells in Buerger's disease

Pluristem Therapeutics Inc., of Haifa, Israel, said its PLacental eXpanded (PLX) cells received FDA orphan drug status in aplastic anemia...The FDA previously granted orphan drug designation to Pluristem's PLX cells in Buerger's disease