The committee is recommending that the product be granted conditional marketing authorization in the European Union for the treatment of adults with previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer

Alexza Pharmaceuticals Inc., of Mountain View, Calif., said it submitted its responses regarding the Adasuve marketing authorization application to the European Medicines Agency (EMA...Ligand Pharmaceuticals Inc., of San Diego, said partner Pfizer Inc., of New York, reported that the European Medicines Agency accepted for review the marketing authorization application for bazedoxifene/conjugated estrogens (BZA/CE), under review for use in postmenopausal women with a uterus for treating estrogen

Alimera Sciences Inc., of Atlanta, said France's National Security Agency of Medicines and Health Products (L'Agence Nationale de Securite du Medicament et des Produits de Sante) granted marketing authorization to Iluvien (fluocinolone acetonide intravitreal insert) for vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies

Active Biotech AB, of Lund, Sweden, said the European Medicines Agency completed the validation process for the marketing authorization application for laquinimod in relapsing-remitting multiple sclerosis (MS), triggering a $5 million milestone payment from partner Teva Pharmaceutical Industries Ltd., of Jerusalem

Arena Pharmaceuticals Inc., of San Diego, said it filed a marketing authorization application with Swiss regulators for obesity candidate lorcaserin hydrochloride, intended as an adjunct to diet and exercise for weight control in patients with an initial body mass index of 30 kg/m(2) or greater, or 27 kg/m(2) or greater in the presence of at least one related comorbid condition

Sanofi SA, of Paris, informed the European Medicines Agency that it is withdrawing its application for marketing authorization for Mulsevo (semuloparin sodium) to prevent venous thromboembolism in certain cancer patients

The company said it plans this month to halt enrollment in its 306B study of Northera in NOH, resulting in top-line data by year-end, while evaluating additional study designs required to support marketing authorization

Sanofi SA, of Paris, informed the European Medicines Agency that it is withdrawing its application for marketing authorization for Mulsevo (semuloparin sodium) to prevent venous thromboembolism in certain cancer patients

Eisai Inc., of Woodcliff Lake, N.J., said the European Medicines Agency approved a marketing authorization application to extend the use of once-daily Zonegran (zonisamide) from adjunctive therapy to also include monotherapy for treating partial seizures in adults with newly diagnosed epilepsy

Medigene AG, of Martinsried, Germany, said Veregen (sinecatechins) received marketing authorization in France for the treatment of genital warts...by various partners, and marketing authorizations are expected in other countries within the next few months

Medigene AG, of Martinsried, Germany, said Veregen (sinecatechins) received marketing authorization in France for the treatment of genital warts...by various partners, and marketing authorizations are expected in other countries within the next few months

Astellas Pharma Inc., of Tokyo, said it submitted a European marketing authorization application for enzalutamide (MDV3100) for treatment of men with metastatic castration-resistant prostate cancer who previously have been treated with docetaxel-based chemotherapy...Buccolam was approved in September 2011 by the European Union through the Pediatric Use Marketing Authorization (PUMA), a marketing authorization procedure for medicines exclusively developed for use in children that are already

Meda AB, of Göteborg, Sweden, said the Committee for Human Medicinal Products of the European Medicines Agency issued a positive opinion regarding marketing authorization of Zyclara (imiquimod) 3.75 percent cream

The company plans to submit a European marketing authorization application for the drug in the third quarter

Meda AB, of Göteborg, Sweden, said the Committee for Human Medicinal Products of the European Medicines Agency issued a positive opinion regarding marketing authorization of Zyclara (imiquimod) 3.75 percent cream

Theratechnologies Inc., of Montreal, said partner Grupo Ferrer Internacional SA, of Barcelona, Spain, is withdrawing the marketing authorization application in Europe for tesamorelin for treating excess abdominal fat in HIV-infected patients with lipodystrophy

Biovest International Inc., of Tampa, Fla., a subsidiary of Accentia Biopharmaceuticals Inc., said it notified the European Medicines Agency (EMA) of its intent to file a marketing authorization application seeking approval in the European Union (EU) for BiovaxID, its personalized cancer vaccine in follicular non-Hodgkin's lymphoma

Gilead Sciences Inc., of Foster City, Calif., said the European Medicines Agency validated its marketing authorization application for elvitegravir, an integrase inhibitor to treat HIV-1 infection in treatment-experienced patients

A marketing authorization application for RP103 is under review for the same indication by the European Medicines Agency