Gentium SpA, of Villa Guardia, Italy, said it was informed that its marketing authorization application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy will be on the agenda for discussion at the European Committee for Medicinal Products for Human Use meetings set for Feb. 18-21

Del Mar Pharmaceuticals Ltd., of Vancouver, British Columbia, reported that the European Committee for Orphan Medicinal Products recommended the designation of VAL-083 as an orphan drug for the treatment of glioma

Gentium SpA, of Villa Guardia, Italy, said it submitted responses to the second list of outstanding issues to the European Committee for Medicinal Products for Human Use in connection with the company's marketing authorization application for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy...Intercell AG, of Vienna, Austria, said the European Committee for Medicinal Products for Human Use (CHMP) issued

Intercell AG, of Vienna, Austria, said the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a marketing authorization application by for Ixiaro, a vaccine against Japanese encephalitis

Gentium SpA, of Villa Guardia, Italy, said it submitted responses to the second list of outstanding issues to the European Committee for Medicinal Products for Human Use in connection with the company's marketing authorization application for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

Genzyme Corp., of Cambridge Mass., a unit of Sanofi SA, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for Kynamro (mipomersen) for the treatment of patients with homozygous familial hypercholesterolemia

Vanda Pharmaceuticals Inc., of Rockville, Md., said the European Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion recommending against approval of Fanaptum (oral iloperidone tablets) for the treatment of schizophrenia in adult patients

At the time of the withdrawal, it was under review by the agency's Committee for Medicinal Products for Human Use (CHMP

Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, said that the European Committee for Orphan Medicinal Products issued a positive opinion on an application for orphan status for Somatoprim, a somatostatin analogue, for treating acromegaly...ATIRT is a cell-based medicinal product candidate enabling stem cell transplantations from mismatched (haploidentical) family donors to patients suffering from blood cancer

Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, said the European Committee for Orphan Medicinal Products issued a positive opinion on an application for orphan status for Somatoprim, a somatostatin analogue, for treating acromegaly

Galen Ltd., of Craigavon, Northern Ireland, said the European Commission designated liposomal daunorubicin as an orphan medicinal product for the treatment of acute myeloid leukemia...and Brazil for the treatment of advanced HIV-related Kaposi's sarcoma, as the medicinal product DaunoXome

Alexza Pharmaceuticals Inc., of Mountain View, Calif., received a Committee for Medicinal Products (CHMP) for Human Use Day 180 Second List of Outstanding Issues from the European Medicines Agency regarding the marketing authorization application for Adasuve (Staccato loxapine

Janssen-Cilag International NV, of Beerse, Belgium, part of Johnson & Johnson, said the European Committee for Medicinal Products for Human Use granted a positive opinion recommending approval of Zytiga (abiraterone acetate) for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer (mCRPC) in men who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy and in whom chemotherapy is not yet clinically

Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Sanofi SA, of Paris, said the European Committee for Medicinal Products for Human Use adopted a positive opinion and recommended approval for Zaltrap (ziv-aflibercept) for intravenous infusion in combination with irinotecan/5-fluorouracil/folinic acid chemotherapy in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen

Galen Ltd., of Craigavon, Northern Ireland, said the European Commission designated liposomal daunorubicin as an orphan medicinal product for the treatment of acute myeloid leukemia...and Brazil for the treatment of advanced HIV-related Kaposi's sarcoma, as the medicinal product DaunoXome

Protalix BioTherapeutics Inc., of Carmiel, Israel, and Pfizer Inc., of New York, said the European Commission refused to grant the marketing authorization application for taliglucerase alfa, an enzyme replacement therapy for Gaucher disease, following a negative recommendation from the Committee for Medicinal Products for Human

Protalix BioTherapeutics Inc., of Carmiel, Israel, and Pfizer Inc., of New York, said the European Commission refused to grant the marketing authorization application for taliglucerase alfa, an enzyme replacement therapy for Gaucher disease, following a negative recommendation from the Committee for Medicinal Products for Human Use (CHMP

In July, the Committee for Medicinal Products for Human Use issued a positive opinion on the drug in the indications, which were approved by the FDA last year

Astellas Pharma Inc., of Tokyo, said the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Betmiga (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adults with overactive bladder syndrome...for turoctocog alfa, a third-generation recombinant coagulation Factor VIII intended for prevention and treatment of bleeding with people with hemophilia A. In other news