The company said it is under regulatory review in 18 territories around the world and was granted marketing authorization under the trade name Brilique by the European Commission on Dec. 6

Pfizer Inc., of New York, announced that the European Commission has approved Sutent (sunitinib malate) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (NET) with disease progression in adults

Taliglucerase alfa earlier this year was granted orphan designation by the European Commission for that indication

Taliglucerase alfa earlier this year was granted orphan designation by the European Commission for that indication

Earlier this year, GlaxoSmithKline was granted marketing authorization from the European Commission for Revolade. (See BioWorld Today, March 15, 2010...Pharming Group NV, of Leiden, the Netherlands, and Swedish Orphan Biovitrum AB, of Stockholm, Sweden, said the European Commission granted approval of Ruconest, a recombinant C1 inhibitor, in acute attacks of hereditary angioedema, triggering a €5 million (US$7 million) to Pharming

Roche, of Basel, Switzerland, said the European Commission approved the use of MabThera (rituximab) as a maintenance treatment for people suffering from follicular lymphoma who have responded to initial induction therapy

Inspiration Biopharmaceuticals Inc., of Laguna Niguel, Calif., said the European Commission granted orphan drug status for OBI-1 in hemophilia

The European Commission (EC) granted orphan drug status to a JAK2 inhibitor by S*BIO Pte Ltd

The European Commission (EC) granted orphan drug status to a JAK2 inhibitor by S*BIO Pte Ltd

Allos Therapeutics Inc., of Westminster, Colo., received orphan drug status from the European Commission for pralatrexate in Hodgkin lymphoma

Archimedes Pharma Ltd., of Reading, UK, received marketing authorization from the European Commission for PecFent, a fentanyl nasal spray for breakthrough cancer pain for patients already on maintenance opioid therapy

Archimedes Pharma Ltd., of Reading, UK, received marketing authorization from the European Commission for PecFent, a fentanyl nasal spray for breakthrough cancer pain for patients already on maintenance opioid therapy

Pluristem Therapeutics Inc., of Haifa, Israel, said that its PLX cell therapy product, derived from human placenta, a noncontroversial, nonembryonic, adult stem cell source, was selected as the only cell therapy product candidate to enter into a study seeking treatments for diastolic heart failure in the European Commission's Seventh Framework Program...Shire plc, of Basingstoke, UK, said the European Commission granted marketing approval for Vpriv (velaglucerase alfa), a human cell line-derived

Pluristem Therapeutics Inc., of Haifa, Israel, said that its PLX cell therapy product, derived from human placenta, a noncontroversial, nonembryonic, adult stem cell source, was selected as the only cell therapy product candidate to enter into a study seeking treatments for diastolic heart failure in the European Commission's Seventh Framework Program

Shire plc, of Basingstoke, UK, said the European Commission granted marketing approval for Vpriv (velaglucerase alfa), a human cell line-derived enzyme replacement therapy, for the long-term treatment of Type I Gaucher disease

Through a separate process, ImmunoGen has received a positive opinion for lorvotuzumab mertansine as an orphan medicinal product for the treatment of SCLC from the European Medicines Agency Committee for Orphan Medicinal Products and is awaiting final designation from the European Commission

Neurim Pharmaceuticals Ltd., of Tel Aviv, Israel, said the European Commission approved a change in treatment duration with Circadin from three weeks to 13 weeks

Bristol-Myers Squibb Co., of New York, said the European Commission approved Orencia (abatacept) in combination with methotrexate in moderate to severe active rheumatoid arthritis in adults who have responded inadequately to previous therapy with one or more disease-modifying drugs, including MTX or a TNF-alpha inhibitor

Neurim Pharmaceuticals Ltd., of Tel Aviv, Israel, said the European Commission approved a change in treatment duration with Circadin from three weeks to 13 weeks