Gilead Sciences Inc., of Foster City, Calif., said the European Medicines Agency validated and will review its marketing authorization application for HIV pill Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate

Genzyme and Isis already have submitted a marketing authorization application to the European Medicines Agency...Additionally, the European Medicines Agency (EMA) validated its marketing authorization

Astellas Pharma Europe Ltd., a subsidiary of Tokyo-based Astellas Pharma Inc., and Optimer Pharmaceuticals Inc., of San Diego, said the European Commission granted marketing authorization for Dificlir (fidaxomicin) tablets for the treatment of adults with Clostridium difficile infections (CDI), also known as Clostridium difficile-associated diarrhea...MediGene AG, of Martinsried, Germany, reported that regulators of 17 additional European countries accepted marketing authorization applications for

MediGene AG, of Martinsried, Germany, reported that regulators of 17 additional European countries accepted marketing authorization applications for Veregen ointment to treat genital warts...Optimer Pharmaceuticals Inc., of San Diego, and Astellas Pharma Europe Ltd., a subsidiary of Tokyo-based Astellas Pharma Inc., said the European Commission granted marketing authorization for Dificlir (fidaxomicin) tablets for the treatment of adults with Clostridium difficile infections (CDI), also known as

Protalix BioTherapeutics Inc., of Carmiel, Israel, said the Irish Medicines Board completed a successful GMP audit of the firm's manufacturing facility in Israel, performed as part of the European Medicines Agency's marketing authorization application review for Gaucher's disease candidate taliglucerase alfa

Ampio said the drug delivery agreement would speed the filing of its marketing authorization applications for Zertane worldwide and enhance licensing and pricing agreements currently in negotiations

Protalix BioTherapeutics Inc., of Carmiel, Israel, said the Irish Medicines Board completed a successful GMP audit of the firm's manufacturing facility in Israel, performed as part of the European Medicines Agency's marketing authorization application review for Gaucher's disease candidate taliglucerase alfa

Pierre Fabre Medicament, of Castres, France, received marketing authorization from the Therapeutic Goods Administration, making its Joncia (milnacipran) the first drug approved in Australia to treat fibromyalgia

Pierre Fabre Medicament, of Castres, France, received marketing authorization from the Therapeutic Goods Administration, making its Joncia (milnacipran) the first drug approved in Australia to treat fibromyalgia

Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., said the European Medicines Agency accepted the marketing authorization application filing for Nuedexta (dextromethorphan HBr and quinidine sulfate) to treat pseudobulbar affect

Dyax Corp., of Cambridge, Mass., said it has decided with partner Sigma-Tau Group, of Rome, to withdraw the European marketing authorization application for hereditary angioedema drug Kalbitor (ecallantide

DuoCort Pharma AB, of Helsingborg, Sweden, said the European Commission granted European Marketing Authorization for Plenadren (hydrocortisone, modified-release tablet), an orphan drug for the treatment of adrenal insufficiency in adults

DuoCort Pharma AB, of Helsingborg, Sweden, said the European Commission granted European Marketing Authorization for Plenadren (hydrocortisone, modified-release tablet), an orphan drug for the treatment of adrenal insufficiency in adults

Alexza Pharmaceuticals Inc., of Mountain View, Calif., submitted a marketing authorization application to the European Medicines Agency for its Adasuve (loxapine) for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder

In other news, Elan and Biogen said the FDA extended by three months the initial PDUFA date for its review of the supplemental biologics license application (sBLA) for Tysabri (natalizumab...Up to 55 percent of cases of wet AMD in Chinese, Japanese and Malay populations are caused by polypoid choroidal vasculopathy, which differs from

Pharmaxis Ltd., of Sydney, Australia, reported that the Committee for Medicinal Products for Human Use recommended the granting of a marketing authorization for Bronchitol, clearing the way for the product to be used in Europe as an add-on therapy to treat cystic fibrosis in adults

Theratechnologies Inc., of Montreal, said an affiliate of partner Sanofi SA, of Paris, submitted a marketing authorization application for Egrifta (tesamorelin) in Mexico with the Federal Commission for the Protection against Sanitary Risk...ThromboGenics NV, of Leuven, Belgium, said the European Medicines Agency accepted for review the marketing authorization application for ocriplasmin (2.5 mg/ml, solution for injection) in symptomatic vitreomacular adhesion including macular hole

European regulators previously accepted a marketing authorization application for the oral mTOR inhibitor

Ipsen also reported that its partner, Inspiration Biopharmaceuticals Inc., has been informed the European Medicines Agency (EMA) has validated and accepted the filing of the marketing authorization application (MAA) for IB1001, a recombinant factor IX product for the treatment of hemophilia B. In January 2010, Inspiration and Ipsen entered into a partnership to develop and commercialize a portfolio of hemophilia products