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

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

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

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

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

The FDA previously granted orphan drug designation to Pluristem's PLX cells in Buerger's disease

The FDA previously granted orphan drug designation to Pluristem's PLX cells in Buerger's disease

SOV Therapeutics Inc., of Morrisville, N.C., said the FDA granted orphan drug designation for the use of oral testosterone undecanoate, a prodrug of testosterone, in the treatment of constitutional delay of growth and puberty (CDGP) in adolescent boys, ages 14 to 17

At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...To date, almost 50 percent of planned patients have been enrolled in about 30 European centers...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

Verastem Inc., of Cambridge, Mass., filed for orphan drug designation for VS-6063 in the U.S

Eisai Inc., of Woodcliff Lake, N.J., said the FDA granted orphan drug designation to its investigational drug lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer

It received orphan drug designation in June 2011...Prolor Biotech Inc., of Ness-Ziona, Israel, received orphan drug designation from the European Commission and the European Medicines Agency for hGH-CTP, a longer-acting human growth hormone being developed for growth hormone deficiency

Addex Therapeutics SA, of Geneva, will focus its resources in its clinical rare disease pipeline, advancing current clinical and pre-investigational new drug application programs that are amenable to orphan drug designation in major markets, including the U.S., Europe and Japan...Apogenix GmbH, of Heidelberg, Germany, said the FDA granted orphan drug designation to Apocept, a drug designed to bind to the CD95 ligand and block activation of the CD95 receptor, in myelodysplastic syndromes (MDS

Addex Therapeutics SA, of Geneva, will focus its resources in its clinical rare disease pipeline, advancing current clinical and pre-investigational new drug application programs that are amenable to orphan drug designation in major markets, including the U.S, Europe and Japan...Apogenix GmbH, of Heidelberg, Germany, said the FDA granted orphan drug designation to Apocept, a drug designed to bind to the CD95 ligand and block activation of the CD95 receptor, in myelodysplastic syndromes (MDS

Diamyd Medical AB, of Stockholm, Sweden, said it's planning to start a new 60-patient study in February with diabetes vaccine Diamyd, testing it in combination with other drugs – relatively high doses of vitamin D and anti-inflammatory drug ibuprofen – to potentiate the effect of the vaccine's ability to help the body control blood sugar levels in newly diagnosed Type I diabetics

The FDA granted orphan drug designation to the product for retinitis pigmentosa

Prosensa Therapeutics BV, of Leiden, the Netherlands, received orphan drug designation in the European Union and the U.S...Soligenix has also previously received orphan drug designation from the FDA for oral BDP for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster