The study was published Friday by the European Commission and by the influential Paris-based policy think tank the Organization for Economic Cooperation and Development (OECD), which is backed by 34 governments

Formal European Commission approval should follow after 67 days, paving the way for a European launch early next year

Galen Ltd., of Craigavon, Northern Ireland, said the European Commission designated liposomal daunorubicin as an orphan medicinal product for the treatment of acute myeloid leukemia

Bristol-Myers Squibb Co., of New York, and Pfizer Inc., also of New York, said the European Commission approved Eliquis (apixaban) for prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation with one or more risk factors...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

Gene therapy, "on the cusp of being successful," as Washer put it, has proved encouraging to the point that labs have begun testing not only in life-threatening diseases, but those with less dire potential outcomes. (See BioWorld Today, Nov. 12, 2012.) This month, Glybera (alipogene tiparvovec) became the first gene therapy to be approved in a regulated market, when the European Commission gave its nod to the compound from uniQure BV, of Amsterdam, the Netherlands

The study was published Friday by the European Commission and by the influential Paris-based policy think tank the Organization for Economic Cooperation and Development (OECD), which is backed by 34 governments

A decision is expected from the European Commission in the first quarter of 2013

Formal European Commission approval should follow after 67 days, paving the way for a European launch early next year

European Commission approved Dacogen 10/1/12 Cytheris SA (Paris) CYT017 Glycosylated recombinant human interleukin-7 Progressive multifocal leukoencephalopathy European Commission granted orphan drug status 10/25/12 Dendreon Corp. (Seattle) Provenge Sipuleucel-T Metastatic castrate-resistant prostate cancer Started enrolling patients in an open-label European study 10/1/12 CARDIOVASCULAR InterMune Inc. (Brisbane, Calif.) Esbriet Pirfenidone Mild to moderate idiopathic pulmonary fibrosis Health

European Commission granted marketing authorization 10/8/12 Chiesi Group (Parma, Italy) CHF 6001 PDE4 inhibitor Asthma and chronic obstructive pulmonary disease Completed a Phase I trial 10/17/12 CSL Behring LLC (King of Prussia, Pa.) Hizentra Immune globulin subcutaneous...European Commission approved Cialis 10/31/12 Eli Lilly and Co. (Indianapolis) Ramucirumab An antibody designed to bind the extracellular domain of vascular endothelial growth factor receptor 2 Metastatic gastric cancer Phase III

Galen Ltd., of Craigavon, Northern Ireland, said the European Commission designated liposomal daunorubicin as an orphan medicinal product for the treatment of acute myeloid leukemia

Bristol-Myers Squibb Co., of New York, and AstraZeneca plc, of London, said the European Commission approved Forxiga (dapaglifozin) tablets for Type II diabetes in the European Union

NewLink Genetics Corp., of Ames, Iowa, said the European Commission designated HyperAcute-Pancreas Immunotherapy (algenpantucel-L) an orphan product, giving the firm development incentives and guaranteeing 10 years of marketing exclusivity upon European approval

The candidate previously received orphan drug designation in the same indications from the European Commission, based on a preclinical data package showing A4250 has high potency, minimal systemic exposure and benefits in an animal model of cholestasis, the predominant feature of PFIC and PBC

The candidate previously received orphan drug designation in the same indications from the European Commission, based on a preclinical data package showing A4250 has high potency, minimal systemic exposure and benefits in an animal model of cholestasis, the predominant feature of PFIC and PBC

In April, the European Commission approved pasireotide under the brand name Signifor for the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed

LONDON – Glybera formally became the first gene therapy to be approved in a regulated market, as the European Commission gave the rubber stamp to the treatment for the ultra-rare inherited disorder lipoprotein lipase deficiency (LPL) on Friday

Protalix BioTherapeutics Inc., of Carmiel, Israel, and Pfizer Inc., of New York, said the European Commission refused to grant the marketing authorization application for taliglucerase alfa, an enzyme replacement therapy for Gaucher disease, following a negative recommendation from the Committee for Medicinal Products for Human

The European Commission approved New York-based Bristol-Myers Squibb Co.'s Baraclude (entecavir) Summary of Product Characteristics update after reviewing new efficacy and safety data in patients with chronic hepatitis B following a liver transplant