ViroPharma Inc., of Exton, Pa., received a Centralized Pediatric Use Marketing Authorization

Theratechnologies Inc., of Montreal, said an affiliate of partner Sanofi SA, of Paris, filed a marketing authorization application for tesamorelin in Argentina to treat excess abdominal fat in HIV-infected patients with lipodystrophy

Those products include IB1001, an IV recombinant factor IX therapy for hemophilia B and OBI-1, an IV recombinant factor VIII product for hemophilia A. Inspiration plans to file a marketing authorization application with the European Medicines Agency by the end of the year

Cell Therapeutics Inc., of Seattle, submitted its response to questions raised by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in relation to the company's marketing authorization application for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma

Inc., of Whitehouse Station, N.J., said the European Medicines Agency accepted for review the marketing authorization application for ridaforolimus in metastatic soft-tissue or bone sarcomas

Inc., of Whitehouse Station, N.J., submitted a marketing authorization application with the European Medicines Agency for ridaforolimus, an investigational mTOR inhibitor for treatment of patients with metastatic sarcomas

Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., reported that it met with the European Medicines Agency to discuss filing a marketing authorization application for Nudexta...Vanda Pharmaceuticals Inc., of Rockville, Md., said the European Medicines Agency accepted its marketing authorization application for oral iloperidone tablets, which are in development for schizophrenia

Plethora Solutions Holdings plc, of London, said that the Medicines Healthcare Regulatory Agency issued notification that its change of ownership of the marketing authorization for Striant from Columbia Laboratories Inc

Plethora Solutions Holdings plc, of London, said that the Medicines Healthcare Regulatory Agency issued notification that its change of ownership of the marketing authorization for Striant from Columbia Laboratories Inc

Optimer also has filed a marketing authorization application for fidaxomicin with the European Medicines Agency and has entered an exclusive collaboration and license agreement with Astellas Pharma Europe Ltd

Amsterdam Molecular Therapeutics NV, of Amsterdam, the Netherlands, filed a request for re-examination of a marketing authorization application with the European Medicines Agency (EMA) for Glybera (alipogene tiparvovec), a gene therapy for lipoprotein lipase deficiency

Amsterdam Molecular Therapeutics NV, of Amsterdam, the Netherlands, filed a request for re-examination of a marketing authorization application with the European Medicines Agency (EMA) for Glybera (alipogene tiparvovec), a gene therapy for lipoprotein lipase deficiency

The European Union validated a marketing authorization application from Nuvo Research Inc., of Mississauga, Ontario, for Pliaglis, a local dermal anesthesia product

The company plans to proceed into a pivotal Phase IIb study for late-stage pancreatic cancer and said German authorities have indicated the study could be sufficient to file for marketing authorization in the European Union

The company plans to proceed into a pivotal Phase IIb study for late-stage pancreatic cancer and said German authorities have indicated the study could be sufficient to file for marketing authorization in the European Union...Theratechnologies Inc., of Montreal, reported that the marketing authorization application (MAA) for tesamorelin submitted by its partner, Ferrer Internacional SA, of Barcelona, Spain, was accepted for review by the European Medicines Agency

Ltd., for the European Medicines Agency's acceptance of the marketing authorization application for it to treat relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma

ViroPharma Inc., of Exton, Pa., said the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of a pediatric use marketing authorization application for Buccolam (midazolam, oromucosal solution) for treating prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents

ViroPharma Inc., of Exton, Pa., announced that the European Commission has granted ViroPharma centralized marketing authorization for Cinryze (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks

Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Bayer HealthCare, of Leverkusen, Germany, announced that Bayer HealthCare submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD