The European Medicines Agency accepted submission of a marketing authorization application for aripiprazole depot formulation by Otsuka Pharmaceutical Co

The European Medicines Agency accepted submission of a marketing authorization application for aripiprazole depot formulation by Otsuka Pharmaceutical Co

Finox Biotech AG, of Burgdorf, Switzerland, said it submitted a marketing authorization application for its biosimilar recombinant follicle-stimulating hormone to the European Medicines Agency Oct. 30...Intercell AG, of Vienna, Austria, said the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a marketing authorization application by for Ixiaro, a vaccine against Japanese encephalitis

Finox Biotech AG, of Burgdorf, Switzerland, said it submitted a marketing authorization application for its biosimilar recombinant follicle-stimulating hormone to the European Medicines Agency Oct. 30

Intercell AG, of Vienna, Austria, said the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a marketing authorization application by for Ixiaro, a vaccine against Japanese encephalitis

Gentium SpA, of Villa Guardia, Italy, said it submitted responses to the second list of outstanding issues to the European Committee for Medicinal Products for Human Use in connection with the company's marketing authorization application for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

Algeta ASA, of Oslo, Norway, said partner Bayer AG, of Leverkusen, Germany, submitted a marketing authorization application to the European Medicines Agency for Alpharadin (radium-223 dichloride) for the treatment of castration-resistant prostate cancer patients with bone metastases

Genzyme Corp., of Cambridge Mass., a unit of Sanofi SA, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for Kynamro (mipomersen) for the treatment of patients with homozygous familial hypercholesterolemia

Algeta ASA, of Oslo, Norway, said partner Bayer AG, of Leverkusen, Germany, submitted a marketing authorization application to the European Medicines Agency for Alpharadin (radium-223 dichloride) for the treatment of castration-resistant prostate cancer patients with bone metastases

Alfa Wassermann SpA, of Bologna, Italy, and Norgine BV, of Amsterdam, the Netherlands, received European marketing authorization for Xifaxan 550-mg (rifaximin-alpha)/Refero/Targaxan/Tixteller for hepatic encephalopathy, a neuropsychiatric condition that can occur with cirrhosis of the liver...AOP Orphan Pharmaceuticals AG, of Vienna, Austria, said it plans to initiate a Phase III study to support European marketing authorization of a monopegylated interferon alpha 2b candidate (AOP2014/P1101) for

Alfa Wassermann SpA, of Bologna, Italy, and Norgine BV, of Amsterdam, the Netherlands, received European marketing authorization for Xifaxan 550-mg (rifaximin-alpha)/Refero/Targaxan/Tixteller for hepatic encephalopathy, a neuropsychiatric condition that can occur with cirrhosis of the liver

PTC Therapeutics Inc., of South Plainfield, N.J., said the European Medicines Agency (EMA) validated a marketing authorization application seeking conditional approval for ataluren, its investigational compound in nonsense mutation Duchenne's muscular dystrophy (nmDMD...Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Bayer AG, of Leverkusen, Germany, said Bayer HealthCare Corp., of Deerfield, Ill., submitted a marketing authorization application in Europe for Eylea (aflibercept) injection

Exelixis Inc., of South San Francisco, said the European Medicines Agency accepted for review the marketing authorization application for Cometriq (cabozantinib) for the proposed indication of progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC...While the product, an intravitreal implant that delivers fluocinolone acetonide, received marketing authorization in the UK, the independent appraisal committee concluded that the evidence provided did not show that the

Inc., of Whitehouse Station, N.J., said it formally notified the European Medicines Agency (EMA) of its decision to withdraw the marketing authorization application for ridaforolimus

Gilead Sciences Inc., of Foster City, Calif., said the European Commission granted marketing authorization for two new indications for once-daily Viread (tenofovir disoproxil fumarate...Ironwood Pharmaceuticals Inc., of Cambridge, Mass., and partner Almirall SA, of Barcelona, Spain, received marketing authorization from the European Commission for Constella (linaclotide 290 mg) for irritable bowel syndrome with constipation

LEO Pharma A/S, of Ballerup, Denmark, said the European Commission granted marketing authorization for Picato (ingenol mebutate) gel as a treatment for actinic keratosis, a skin condition that can lead to squamous cell carcinoma if not treated

Inc., of Whitehouse Station, N.J., said the European Medicines Agency accepted for review a marketing authorization application for vintafolide (MK-8109/EC145) and the diagnostic imaging agent etarfolatide (EC20), which are in development for targeted treatment of folate-receptor-positive, platinum-resistant ovarian cancer in combination with pegylated liposomal doxorubicin

The TGA approval will enable health professionals to prescribe Aubagio 14 mg in Australia, which is now the second country to gain marketing authorization for the treatment, following FDA approval in September. (See BioWorld Today, Sept. 14, 2012

LEO Pharma A/S, of Ballerup, Denmark, said the European Commission granted marketing authorization for Picato (ingenol mebutate) gel as a treatment for actinic keratosis, a skin condition that can lead to squamous cell carcinoma if not treated