Forest/Pierre Fabre now aiming for Q4 levomilnacipran MDD filing
This article was originally published in Scrip
Executive Summary
Forest Laboratories and Pierre Fabre Medicament plan to file a new drug application (NDA) for levomilnacipran for the treatment of adults with major depressive disorder (MDD) with the US FDA by the end of this year, after the third out of four Phase III trials produced positive top-line results. This timing is a little later than the mid-2012 date previously given, and follows a difficult development programme with the product.
You may also be interested in...
Topotarget reconfirms mid-2013 US NDA for belinostat as it looks to Q3 milestone
Danish firm Topotarget said it was 'very confident' that it will be able to raise its first milestone from partner, Spectrum Pharmaceuticals, by the third quarter as it reported that final top-line data confirm that the primary endpoint was met in the Phase II BELIEF trial investigating an intravenous formulation of the histone deacetylase (HDAC) inhibitor, belinostat, for peripheral T-cell lymphoma (PTCL).
AstraZeneca wins EU approval of rare thyroid cancer drug vandetanib
AstraZeneca's Caprelsa (vandetanib) has become the first treatment to be approved for advanced medullary thyroid cancer (MTC) in Europe after being granted marketing authorisation by the European Commission.
Solid but not spectacular: Victoza's weight loss verdict in non-diabetics
Despite reporting positive weight loss data from the third of four Phase IIIa trials from the SCALE program investigating liraglutide (Victoza) for obesity Novo Nordisk has failed to dazzle analysts who have questioned the commercial potential of the drug in this arena.