Forster said discussions Creabilis has had with the European Medicines Agency indicated it would be possible to get labeling covering dermatological and other systemic diseases

Colin Reisner, chief medical officer for Pearl, told BioWorld Today that the company completed its dose-ranging studies at the end of 2012 and has had discussions with the European Medicines Agency, Health Canada and the FDA, including an end-of-Phase-II meeting with the FDA

In addition to ALL, the agreement covers use of Graspa in treating acute myeloid leukemia, and in January Erytech received approval from the French medicine agency to start a Phase IIb trial in the indication

Marketing authorization application (MAA) filings for both vintafolide and etarfolatide have been accepted for review by the European Medicines Agency (EMA), and they are are currently being evaluated in a Phase III randomized, double-blind trial for platinum-resistant ovarian cancer (PROCEED trial) and a Phase IIb trial in patients with non-small-cell lung cancer (NSCLC

EMA = European Medicines Agency

Forster said discussions Creabilis has had with the European Medicines Agency indicated it would be possible to get labeling covering dermatological and other systemic diseases

Isis and Genzyme, a unit of Paris-based Sanofi SA that licensed Kynamro in 2008 for up to $1 .9 billion, continue to pursue approval in Europe, where the European Medicines Agency's Committee for Medicinal Products for Human Use has twice given the drug a thumb's down in HoFH, and in broader cardiovascular indications, including the more common familial hypercholesterolemia, which is being investigated in the 60-week FOCUS FH study under an FDA special protocol assessment. (See BioWorld Today

Europe's regulator, the London-based European Medicines Agency (EMA) suffered a recent setback to its plans to introduce a new data transparency regime from the beginning of next year. (See BioWorld Today, March 12, 2013.) AbbVie Inc., of Chicago, and Brisbane, Calif.-based InterMune Inc

In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting an indication extension to include treatment of earlier-line metastatic breast cancer patients

Active Biotech AB, of Lund, Sweden, and Ipsen SA, of Paris, said they now plan to conduct the primary progression-free survival analysis for the 10TASQ10 global Phase III trial of tasquinimod in 2014, at the same time as the first interim overall survival analysis, when more mature data are available. The product, a small molecule that binds to S100A9, is the subject of a study across 37 countries in 1,245 metastatic castrate-resistant prostate cancer patients who have not yet received

In March 2012, the European Medicines Agency accepted Raptor's marketing authorization application for RP103

Omeros Corp., of Seattle, said the European Medicines Agency granted eligibility for centralized review of the company's planned marketing authorization application (MAA) for ophthalmology candidate OMS302 (ketorolac and phenylephrine

Almac Discovery, a Craigavon, Northern Ireland-based member of Almac Group Ltd., licensed its anti-angiogenic peptide ALM201 to Shin Poong Pharmaceutical Co. Ltd., of Seoul, South Korea, for clinical development and marketing in South Korea. Shin Poong will make undisclosed up-front and milestone payments, along with royalties. The South Korean development program will run parallel with Almac's development program in Europe, where the cancer compound is entering Phase I/II trials in the UK

BioMarin Pharmaceutical Inc., of San Rafael, Calif., said it submitted a marketing authorization application to the European Medicines Agency for Vimizim (BMN-110, elosulfase alfa), an enzyme replacement therapy for patients with rare lysosomal storage disorder mucopolysaccharidosis Type IVA, also called Morquio A syndrome

Medivir AB, of Stockholm, Sweden, said Janssen-Cilag International NV, of Beerse, Belgium, part of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency seeking approval for the protease inhibitor simeprevir (TMC435) for hepatitis C virus patients

The European Medicines Agency's Committee for Orphan Medicinal Products has granted the hESC-derived RPE cells orphan medicinal product designation for the treatment of SMD

As a result, Flunisyn matches the wish list of the FDA, the European Medicines Agency and the World Health Organization for a vaccine that is effective against multiple strains of both seasonal and pandemic flu, provides coverage for immune-compromised groups, does not need to be reformulated for each flu season, can be manufactured in a low-cost, timely way and is stable enough to be stockpiled

As a result, Flunisyn matches the wish list of the FDA, the European Medicines Agency and the World Health Organization for a vaccine that is effective against multiple strains of both seasonal and pandemic flu, provides coverage for immune-compromised groups, does not need to be reformulated for each flu season, can be manufactured in a low-cost, timely way and is stable enough to be stockpiled

EMA = European Medicines Agency