Can-Fite BioPharma Ltd., of Petah-Tikva, Israel, said the FDA granted orphan drug status to CF102, its candidate in hepatocellular carcinoma (primary liver cancer

Arno Therapeutics Inc., of Flemington, N.J., said its investigational compound, AR-42, was granted orphan drug designation by the FDA for the treatment of meningioma and schwannoma of the central nervous system...SecreFlo, a synthetic version of the human hormone secretin, has orphan drug status

CSL Behring LLC, of King of Prussia, Pa., a subsidiary of CSL Ltd., received orphan drug designation from the FDA for rVIIa-FP, its recombinant fusion protein linking coagulation Factor VIIa with albumin, for the treatment and prophylaxis of bleeding episodes in patients with congenital hemophilia and inhibitors to coagulation Factor VIII or IX

Glenveigh Medical LLC, of Chattanooga, Tenn., said the FDA granted orphan drug designation for digoxin immune fab (ovine) as a potential therapy for severe preeclampsia and eclampsia

Scenesse received orphan drug designation in 2008 and will be reviewed under the EMA's centralized procedure...DCPrime BV, of Amsterdam, the Netherlands, said it received orphan drug designation in Europe for DCP-001 , a therapeutic vaccine, in acute myeloid leukemia (AML

Scenesse received orphan drug designation in 2008 and will be reviewed under the EMA's centralized procedure. (See BioWorld Today, Dec. 21, 2011...DCPrime BV, of Amsterdam, the Netherlands, said it received orphan drug designation in Europe for DCP-001, a therapeutic vaccine, in acute myeloid leukemia (AML

DelMar Pharmaceuticals Ltd., of Vancouver, British Columbia, said the FDA granted orphan drug designation for VAL-083, a small-molecule chemotherapeutic for the treatment of glioma, including glioblastoma multiforme (GMB

Ikaria Inc., of Hampton, N.J., said the FDA granted orphan drug designation for the use of inhaled nitric oxide with the INOpulse DS drug delivery system as a combination product for pulmonary arterial hypertension

Ceptaris Therapeutics Inc., of Malvern, Pa., said the European Medicines Agency granted orphan drug designation to its investigational drug chlormethine gel, also known as mechlorethamine gel in the U.S., for cutaneous T-cell lymphoma (CTCL

Phytopharm has orphan drug status in Europe and the U.S

AiCuris GmbH & Co., of Wuppertal, Germany, said the FDA granted orphan drug status for AIC246 (letermovir), an inhibitor of human cytomegalovirus (HCMV), for the prevention of HCMV viremia and disease in at-risk populations...orphan drug status for its hemophilia B program to the European orphan status granted in November 2011

AiCuris GmbH & Co., of Wuppertal, Germany, said the FDA granted orphan drug status for AIC246 (letermovir), an inhibitor of human cytomegalovirus (HCMV), for the prevention of HCMV viremia and disease in at-risk populations

Halo Therapeutics LLC, of Newton, Mass., said the FDA granted orphan drug designation for HT-100 (halofuginone) for treatment of the neuromuscular disorder Duchenne's muscular dystrophy (DMD

However, since German law requires orphan drugs to be deemed beneficial, the IQWiG assessed Esbriet's additional benefit as given but not quantifiable

Emergent BioSolutions Inc., of Rockville, Md., said its humanized anti-CD37 mono-specific protein therapeutic, TRU-016, for B-cell malignancies was granted orphan drug designation by the FDA for chronic lymphocytic leukemia (CLL

Summit Corp., of Oxford, UK, said the FDA granted orphan drug status to SMT C1100 to treat Duchenne's muscular dystrophy...That follows the European Medicines Agency granting the product orphan drug status in December 2008

Summit Corp., of Oxford, UK, said the FDA granted orphan drug status to SMT C1100 to treat Duchenne's muscular dystrophy, a genetic neuromuscular disorder...The European Medicines Agency granted SMT C1100 orphan drug status in December 2008

Amsterdam Molecular Therapeutics NV, of Amsterdam, the Netherlands, received orphan drug designation from the European Medicines Agency for its hemophilia B gene therapy

Amsterdam Molecular Therapeutics NV, of Amsterdam, the Netherlands, received orphan drug designation from the European Medicines Agency for its hemophilia B gene therapy