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.
The European Commission has approved the Roche group’s breast cancer treatment, Herceptin (trastuzumab), for metastatic stomach cancer. The drug is to be used in combination with chemotherapy for patients with HER2-positive stomach cancer.
A monoclonal antibody developed by Genmab A/S of Denmark and GlaxoSmithKline has won a positive opinion from the European Medicines Agency for the treatment of leukaemia, conditional upon the companies’ providing updates on the drug’s use.
Actelion Ltd of Switzerland has received the support of an advisory committee of the US Food and Drug Administration to expand the use of its drug for Gaucher disease to include Niemann-Pick disease.