EMA recommends lifting suspension on aprotinin products
This article was originally published in Scrip
The European Medicines Agency has recommended that the suspension of the marketing authorisations for aprotinin-containing medicines in the European Union (EU) be lifted - a move that "follows a full review of the benefits and risks of all antifibrinolytic medicines, which found that the results of the BART study on which the suspension was based are unreliable", it said.
You may also be interested in...
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'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.
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.