The company expects to submit a new drug application in PsA to the FDA in the first quarter of 2013 and a combined marketing authorization application in PsA and moderate-to-severe psoriasis to the European Medicines Agency in the second half of 2013

SFJ will provide funding and clinical development supervision to generate sufficient clinical data to support a registration dossier on dacomitinib for marketing authorization by regulatory authorities in first-line treatment of patients with NSCLC

AMAG Pharmaceuticals Inc., of Lexington, Mass., received marketing authorization in Switzerland for Reinso (ferumoxytol) for iron deficiency anemia in adults with chronic kidney disease

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency seeking conditional approval for the use of TMC207 (bedaquiline) as part of combination therapy for pulmonary, multidrug-resistant tuberculosis (MDR-TB

Pfizer Inc., of New York, said the European Commission granted marketing authorization for Inlyta (axitinib) in adult patients with advanced renal cell carcinoma after failure of prior treatment with Sutent (sunitinib) or a cytokine

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency seeking conditional approval for the use of TMC207 (bedaquiline) as part of combination therapy for pulmonary, multidrug-resistant tuberculosis (MDR-TB

Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it submitted a marketing authorization application for ponatinib, its BCR-ABL inhibitor, to the European Medicines Agency to treat adults with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL

Meda AB, of Göteborg, Sweden, said the European Commission has granted marketing authorization for Zyclara (imiquimod 3.75 percent cream) for the treatment of actinic keratosis in the EU

Meda AB, of Göteborg, Sweden, said the European Commission has granted marketing authorization for Zyclara (imiquimod 3.75% cream) for the treatment of actinic keratosis in the EU

Dynavax Technologies Corp., of Berkeley, Calif., said the European Medicines Agency (EMA) accepted the marketing authorization application (MAA) filing for Heplisav, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults, ages 18 to 70, and in patients with chronic kidney disease

It plans to apply for marketing authorization for trametinib in Europe in the coming months

It plans to apply for marketing authorization for trametinib in Europe in the coming months

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said the European Commission granted marketing authorization to Jentadueto (linagliptin/metformin hydrochlorid) in Type II diabetes...In addition, the company reported the European Commission issued marketing authorization approval for the use of Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures (the most common type of epilepsy) in people with epilepsy age 12 and older

Arena Pharmaceuticals Inc., of San Diego, transferred the Belviq (lorcaserin hydrochloride) new drug application to partner Eisai Inc., of Woodcliff Lake, N.J., which establishes Eisai as the marketing authorization holder responsible for regulatory activities in the U.S

Eisai Europe Ltd., of Hatfield, UK, part of Eisai Inc., reported the European Commission (EC) has issued marketing authorization approval for the use of Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures (the most common type of epilepsy) in people with epilepsy age 12 and older

Alimera Sciences Inc., of Atlanta, and pSivida Corp., of Watertown, Mass., said the Federal Ministry of Health of Germany granted marketing authorization to Iluvien, an intravitreal implant delivering fluocinolone acetonide, for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies

Eli Lilly and Co., of Indianapolis, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the European Commission granted marketing authorization to Jentadueto (linagliptin/metformin hydrochlorid) in Type II diabetes

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

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