Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency for a fixed-dose combination of canglifozin and immediate-release metformin for Type II diabetes

Ltd., of Osaka, Japan, said it submitted a marketing authorization application to the European Medicines Agency for vedolizumab, a gut-selective humanized monoclonal antibody, for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency for a fixed-dose combination of canglifozin and immediate-release metformin for Type II diabetes

A new drug application and marketing authorization are planned for the third quarter...The marketing authorization applies to all 27 European Union member states

The marketing authorization applies to all 27 European Union member states...Mechlorethamine gel has orphan status in the U.S. Ceptaris said it also plans to submit a marketing authorization application in Europe in mid-2013. (See BioWorld Today, Aug. 30, 2012

Anika Therapeutics Inc., of Bedford, Mass., notified the European Medicines Agency that it decided to withdraw its application for centralized marketing authorization for Hyalograft C autograft (cultured autologous chondrocytes on hyaluronan-based scaffold), intended for the surgical repair of symptomatic cartilage defects of the femoral condyle or trochlea caused by acute or repetitive trauma in adults

The European Medicines Agency has accepted the marketing authorization application for Cometriq...After considering the grounds for this request, CHMP again declined the marketing authorization on Feb. 21

Alexza Pharmaceuticals Inc., of Mountain View, Calif., and Grupo Ferrer Internacional SA, of Barcelona, Spain, said the European Commission granted marketing authorization for Adasuve (Staccato loxapine...Gentium SpA, of Villa Guardia, Italy, made an oral presentation for the European Medicines Agency's Committee for Medicinal Products for Human Use supporting its marketing authorization application for Defibrotide in hepatic veno-occlusive disease in adults and children receiving hematopoietic

and Europe to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adults with active psoriatic arthritis and for active axial spondyloarthritis

Intercell AG, of Vienna, Austria, said the pediatric indication for Ixiaro, a vaccine to protect against Japanese encephalitis (JE), was granted marketing authorization by the European Medicines Agency and the European Commission

GlaxoSmithKline plc, of London, said it submitted a marketing authorization application to the European Medicines Agency (EMA) for trametinib (ME) as a monotherapy and in combination with dabrafenib (BRAF) for the treatment of adults with unresectable or metastatic melanoma with a BRAFV600 mutation...Ipsen SA, of Paris, and Braintree Laboratories Inc., of Braintree, Mass., said that Eziclen/Izinova (BLI-800) completed the European decentralized registration procedure, giving member states 30 days

Intercell AG, of Vienna, Austria, said the pediatric indication for Ixiaro, a vaccine to protect against Japanese encephalitis (JE), was granted marketing authorization by the European Medicines Agency and the European Commission

GlaxoSmithKline plc, of London, said it submitted a marketing authorization application to the European Medicines Agency (EMA) for trametinib (ME) as a monotherapy and in combination with dabrafenib (BRAF) for the treatment of adults with unresectable or metastatic melanoma with a BRAFV600 mutation...Ipsen SA, of Paris, and Braintree Laboratories Inc., of Braintree, Mass., said that Eziclen/Izinova (BLI-800) completed the European decentralized registration procedure, giving member states 30 days

Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Sanofi SA, of Paris, said the European Commission granted marketing authorization in the European Union for Zaltrap (ziv-aflibercept) for infusion in combination with irinotecan/5-fluorouracil/folinic acid (Folfiri) chemotherapy in metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen

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

Pfizer Inc., of New York, said the Committee for Medicinal Products for Human Use of the European Medicines Agency offered a positive opinion on the conditional marketing authorization of bosutinib in the European Union (EU) in chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukemia patients previously treated with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment

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...pSivida Corp., of Watertown, Mass., and Alimera Sciences Inc., of Atlanta, said the Spanish Agency of Drugs and

Theravance Inc., of South San Francisco, and GlaxoSmithKline plc, of London, submitted a marketing authorization application in the European Union for UMEC-VI, for chronic obstructive pulmonary disease

Savient Pharmaceuticals Inc., of Bridgewater, N.J., said the European Commission granted marketing authorization to Krystexxa (pegloticase) for the treatment of severe debilitating chronic tophaceous gout in adults who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom those medications are contraindicated