Millennium: The Takeda Oncology Co., of Cambridge, Mass., said the European Commission (EC) granted conditional marketing authorization for Adcetris (brentuximab vedotin) in relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant or at least two prior therapies in transplant-ineligible patients and in relapsed or refractory systemic anaplastic large-cell lymphoma...The marketing authorization, which will be held by Takeda Global Research & Development Centre

Sosei Group Corp., of Tokyo, and Novartis AG, of Basel, Switzerland, said a marketing authorization application was filed in Europe for QVA149 (indacaterol maleate/glycopyrronium bromide) in chronic obstructive pulmonary disease

Pfizer Inc., of New York, said the European Commission gave conditional marketing authorization for Xalkori (crizotinib) for the treatment of adults with previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer

AB Science SA, of Paris, said masitinib has been submitted in a marketing authorization application in Europe for the treatment of pancreatic cancer...Under the agreement, Shafayab will get rights to import, promote and market the product in Iranian territories, though BioAlliance will remain the marketing authorization holder

Under the agreement, Shafayab will get rights to import, promote and market the product in Iranian territories, though BioAlliance will remain the marketing authorization holder

AB Science SA, of Paris, said masitinib has been submitted in a marketing authorization application in Europe for the treatment of pancreatic cancer

Gentium SpA, of Villa Guardia, Italy, said it received a second list of outstanding issues from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use in connection with its marketing authorization application for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing haematopoietic stem cell transplantation therapy

Gentium SpA, of Villa Guardia, Italy, said it received a second list of outstanding issues from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use in connection with its marketing authorization application for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing haematopoietic stem cell transplantation therapy

Bristol-Myers Squibb Co., of New York, said the European Commission granted marketing authorization for the subcutaneous formulation of Orencia (abatacept) in combination with methotrexate for the treatment of adults with moderate to severe active rheumatoid arthritis

AcelRx Pharmaceuticals Inc., of Redwood City, Calif., said the European Medicines Agency (EMA) agreed to permit registration of the Sufentanil NanoTab PCA System (ARX-01) via its centralized review process, enabling AcelRx to submit a single marketing authorization application for ARX-01 in all 27 European Union member states and four European Free Trade Association countries through a single evaluation by the Committee for Medicinal Products for Human Use...Early last year, the European Commission

In exchange, Vestiq will become the marketing authorization holder of the product and will assume all related responsibilities...Gentium SpA, of Villa Guardia, Italy, said the European Committee for Medicinal Products for Human Use (CHMP) decided to adopt a second List of Outstanding Issues relating to its marketing authorization application for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation therapy

Endocyte said it expects to submit marketing authorization applications to European health authorities in the fourth quarter of 2012...Protalix BioTherapeutics Inc., of Carmiel, Israel, said it received marketing authorization in Israel for Elelyso (taliglucerase alfa) for injection, an enzyme replacement therapy for the long-term treatment of adults with Type I Gaucher disease

Gentium SpA, of Villa Guardia, Italy, said the European Committee for Medicinal Products for Human Use (CHMP) decided to adopt a second List of Outstanding Issues relating to its marketing authorization application for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation therapy

In exchange, Vestiq will become the marketing authorization holder of the product and will assume all related responsibilities

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it submitted a marketing authorization application to the European Medicines Agency for approval of afatinib, an irreversible ErbB family blocker, as a treatment for patients with EGFR mutation-positive non-small-cell lung cancer

If a negative recommendation is issued, depending on the nature of the objections, the company said it either will resubmit the marketing authorization application at a later date or will appeal the decision and request and re-examination

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it submitted a marketing authorization application to the European Medicines Agency for approval of afatinib, an irreversible ErbB family blocker, as a treatment for patients with EGFR mutation-positive non-small-cell lung cancer...Lundbeck A/S, of Copenhagen, Denmark, said it submitted a marketing authorization application to the European Medicines Agency seeking approval of multimodal antidepressant vortioxetine (lu AA21004

Biovest International Inc., of Tampa, Fla., a subsidiary of Accentia Biopharmaceuticals Inc., said it recently conducted a regulatory meeting with the European Medicines Agency regarding its personalized cancer vaccine BiovaxID for non-Hodgkin's lymphoma, and said the meeting should support final preparation and filing of a marketing authorization application anticipated early next year

In other news, 3SBio said its special committee of independent directors has retained Cleary Gottlieb Steen & Hamilton LLP, of New York, as the committee's legal counsel...In other news, Boehringer said it started an open-label U.S...The objectives are to decrease or stabilize the number of blood-circulating CLL cells and to delay the onset of other signs of progression, such as swelling of lymph nodes, which then requires immunochemotherapy treatment