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

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

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

Theratechnologies Inc., of Montreal, said partner Ferrer Internacional SA, of Barcelona, Spain, filed a marketing authorization application in Europe for tesamorelin, an analogue of the growth hormone-releasing factor, for treating excess abdominal fat in adult HIV-infected patients with lipodystrophy

Savient Pharmaceuticals Inc., of East Brunswick, N.J., said the European Medicines Agency accepted and will review the marketing authorization application for gout drug Krystexxa (pegloticase

Amsterdam Molecular Therapeutics, of Amsterdam, the Netherlands, said it submitted Day 180 questions to the European Medicines Agency as part of the marketing authorization application for Glybera (alipogene tiparvovec), its gene therapy product for the treatment of lipoprotein lipase deficiency, and expects a decision by midyear

Amsterdam Molecular Therapeutics, of Amsterdam, the Netherlands, reported that the company has submitted Day 180 questions to the European Medicines Agency as part of the marketing authorization application for Glybera (alipogene tiparvovec), its gene therapy product for the treatment of lipoprotein lipase deficiency, and anticipates a decision by mid-2011

The EMA will require data from the pediatric trial to be included in the marketing authorization application

The EMA will require data from the pediatric trial to be included in the marketing authorization application

Savient Pharmaceuticals Inc., of East Brunswick, N.J., has delivered its marketing authorization application to the European Medicines Agency for Krystexxa (pegloticase) for chronic gout

Results of the trial will be used to support a European Marketing Authorization Application, planned for the first quarter of 2012

NicOx SA, of Sophia-Antipolis, France, withdrew its marketing authorization application for osteoarthritis candidate naproxcinod from the centralized procedure in Europe, citing feedback from a meeting of the Committee for Medicinal Products for Human Use (CHMP