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Regulation & Policy
Recentin fails to meet primary endpoint in cancer trial
Monday 8 March 2010
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.
Location
United Kingdom
Roche and Biogen Idec suspend RA trials with ocrelizumab
Monday 8 March 2010
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.
Location
Switzerland
EMA seeks to work with government payers
Monday 1 March 2010
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.
Location
United Kingdom
FDA approves Shire product for Gaucher disease
Monday 1 March 2010
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.
Location
United States
FDA accelerates review of Shire product
Wednesday 24 February 2010
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.
Location
United Kingdom
FDA gives Novartis MS drug priority review status
Monday 22 February 2010
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.
Location
United States
EMA recommends conditional approval of GSK cancer drug
Monday 22 February 2010
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.
Location
United Kingdom
FDA approves MabThera for leukaemia
Friday 19 February 2010
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.
Location
Switzerland
SMEs get more products approved
Wednesday 10 February 2010
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.
Location
United Kingdom
EMA invites comments on its future strategy
Sunday 31 January 2010
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.
Location
United Kingdom
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Recent Appointments
Pascale Witz to head strategic development at Sanofi
Monday May 6 2013
Srinivas Akkaraju joins Sofinnova Ventures
Monday May 6 2013
Vicente Anido nominated to Nicox board
Monday May 6 2013
Jeremy Farrar named director of the Wellcome Trust
Monday May 6 2013
Harry Kirsch becomes CFO at Novartis
Monday May 6 2013