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Regulation & Policy
Ark Therapeutics drops Cerepro appeal
Tuesday 9 March 2010
Ark Therapeutics Group Plc has dropped its appeal against a negative opinion from the European Medicines Agency for its gene therapy for brain cancer, Cerepro. It also announced that it is in talks about a possible takeover of the company. Ark disclosed the developments on 9 March 2010.
Location
United Kingdom
See map: Google Maps
Zalutumumab fails to meet primary endpoint of overall survival
Tuesday 9 March 2010
Genmab A/S said that its antibody for head and neck cancer, zalutumumab, has failed to show overall survival in a Phase 3 study in which the drug was being tested in combination with best supportive care versus best standard care alone.
Location
Denmark
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
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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
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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
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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
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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
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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
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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
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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
See map: Google Maps
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Recent Appointments
Tim Edwards elected chairman of BIA
Tuesday September 7 2010
Index Ventures appoints antibody expert as partner
Friday September 3 2010
Colin Stewart appointed CEO at Amarin
Friday August 20 2010
Karl Keegan nominated as CFO of Pharming
Friday August 20 2010
Axel Müller becomes CEO at SkyePharma
Thursday August 19 2010