Biovest International Inc., a subsidiary of Accentia Biopharmaceuticals Inc., both of Tampa, Fla., said it plans to file a marketing authorization application with the European Medicines Agency (EMA) for BiovaxID, its personalized cancer vaccine in follicular non-Hodgkin's lymphoma, following pre-filing meetings with the EMA

Cell Therapeutics Inc., of Seattle, received conditional marketing authorization from the European Commission for Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas

In other news, Gentium said it received the Day 180 list of outstanding issues from the European Committee for Medicinal Products for Human Use in connection with the marketing authorization application for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

pSivida Corp., of Watertown, Mass., said the UK's Medicines and Healthcare products Regulatory Agency granted marketing authorization for Iluvien as a second-line treatment for vision impairment associated with chronic diabetic macular edema

Gentium SpA, of Villa Guardia, Italy, said it received the Day 180 list of outstanding issues from the European Committee for Medicinal Products for Human Use in connection with the marketing authorization application for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

Pharmaxis Ltd., of Sydney, Australia, received marketing authorization from the European Commission for Bronchitol as an add-on therapy to treat cystic fibrosis in adults

Pharmaxis Ltd., of Sydney, Australia, received marketing authorization from the European Commission for Bronchitol as an add-on therapy to treat cystic fibrosis in adults

pSivida Corp., of Watertown, Mass., said the Austrian Agency for Health and Food Safety granted marketing authorization to Iluvien, a sustained-release intravitreal insert designed to release submicrogram levels of fluocinolone acetonide for up to 36 months, to treat vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies

In other news, Biostar, via its Xhaanxi Winan subsidiary, has been selected to exclusively supply Huanghangning tablets, for cardiovascular disease, to all hospitals in Liaoning, Hebei, and Shandong for up to three years...In other news, Boehringer launched a worldwide registry to study treatment regimes for stroke prevention in nonvalvular atrial fibrillation and respective patient outcomes...In other news, Janssen launched a division, Janssen Therapeutics EMEA, dedicated to bringing investigational

Allos Therapeutics Inc., of Westminster, Colo., said the European Committee for Medicinal Products for Human Use (CHMP) confirmed its previous negative opinion on the marketing authorization application for Folotyn (pralatrexate) in peripheral T-cell lymphoma (PTCL) patients whose disease has progressed after at least one prior systemic therapy...SkyePharma plc, of London, reported Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a

Raptor Pharmaceuticals Corp., of Novato, Calif., said the European Medicines Agency accepted for review the marketing authorization application for RP103 (cysteamine bitartrate gastroresistant capsules) as a potential treatment of nephropathic cystinosis...Vivus Inc., of Mountain View, Calif., said a marketing authorization application was accepted for review by the European Medicines Agency for avanafil in erectile dysfunction

Aegerion Pharmaceuticals Inc., of Cambridge, Mass., said the European Medicines Agency accepted a marketing authorization application for review regarding lomitapide in homozygous familial hypercholesterolemia

Merck Serono SA, of Geneva, a division of Merck KGaA, said Russian regulators granted marketing authorization of Pergoveris (recombinant human follitropin alfa and recombinant human lutropin alfa) for the stimulation of follicular development in women with severe luteinizing hormone and follicle-stimulating hormone deficiency, and for controlled ovarian stimulation in suboptimal responders in assisted reproductive technologies

Merck Serono SA, of Geneva, a division of Merck KGaA, said Russian regulators granted marketing authorization of Pergoveris (recombinant human follitropin alfa and recombinant human lutropin alfa) for the stimulation of follicular development in women with severe luteinizing hormone and follicle-stimulating hormone deficiency, and for controlled ovarian stimulation in suboptimal responders in assisted reproductive technologies

If conditional marketing authorization is granted, its ongoing PROCEED trial would serve as a confirmatory trial to support conversion to regular marketing authorization

Aegerion Pharmaceuticals Inc., of Cambridge, Mass., said it submitted a new drug application and a marketing authorization application seeking approval of lead compound lomitapide as an adjunct to a low-fat diet and other lipid-lowering therapies to reduce cholesterol in patients with homozygous familial hypercholesterolemia (HoFH...Repligen Corp., of Waltham, Mass., said it submitted a marketing authorization application in Europe for SecreFlo (synthetic human secretin) to improve pancreatic

Baxter International Inc., of Deerfield, Ill., said the European Commission granted marketing authorization of Vepacel, a pre-pandemic influenza vaccine indicated for active immunization in adults, ages 18 and older, against the H5N1 subtype of influenza A. The label includes use in immunocompromised and chronically ill patients

Arena Pharmaceuticals Inc., of San Diego, said it filed a marketing authorization application in Europe for weight loss drug lorcaserin for use in patients who are obese, with a body mass index (BMI) of 30 or higher or who are overweight (BMI > 27) and have at least one weight-related co-morbidity

The company said it would submit a marketing authorization application in Europe within days