AstraZeneca Plc said that its candidate drug, Recentin (cediranib), for patients with first-line metastatic colorectal cancer, failed to meet its primary endpoint of non-inferiority in progression-free survival in a Phase 2/3 trial.
The Roche Group and Biogen Idec of the US have suspended clinical trials of the humanized anti-CD20 monoclonal antibody, ocrelizumab, in four rheumatoid arthritis trials because of safety issues. The drug was in Phase 2 and 3 trials.
The European Medicines Agency (EMA) is looking at ways it can work more closely with government bodies in Europe whose responsibility it is to decide whether or not to subsidize a new medicine based on its relative effectiveness.
The US Food and Drug Administration has approved Shire Plc’s treatment for Gaucher disease, Vpriv (velaglucerase alfa), under a special procedure where the review was completed in six months rather than the usual 10.
The US Food and Drug Administration has accelerated its review of a new product for Fabry disease produced by Shire Plc as supply shortages of the only currently marketed treatment for the disease continue.
The US Food and Drug Administration has given Novartis AG’s investigational drug for multiple sclerosis, fingolimod, priority review status, a speedier regulatory pathway for drugs that promise major advances in treatment.
The European Medicines Agency (EMA) has recommended approval of GlaxoSmithKline’s new angiogenesis inhibitor for renal cell cancer, Votrient (pazopanib), conditional on further proof of the drug’s effectiveness.
The US Food and Drug Administration has approved MabThera ( rituximab), plus chemotherapy, for people with previously untreated or previously treated CD20-positive chronic lymphocytic leukaemia, the Roche group announced.
Small and medium-sized companies (SMEs) in the European Union are getting more products approved by the European drug regulator than ever before. But their success rate is still far behind that of Europe’s larger and better capitalised companies.
The European Medicines Agency (EMA) is inviting comments from industry, healthcare professionals and the public on its proposed strategy for the next five years, a period during which infectious disease and demographic change will put new demands on the drug regulatory system.