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Regulation & Policy
Actelion receives FDA complete response letter for Zavesca
Tuesday 9 March 2010
Location
Switzerland
Actelion Ltd said that it has received a complete response letter from the US Food and Drug Administration for its treatment for Niemann-Pick disease, Zavesca (miglustat). This means the agency cannot approve the application in its present form.
Ark Therapeutics drops Cerepro appeal
Tuesday 9 March 2010
Location
United Kingdom
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.
Zalutumumab fails to meet primary endpoint of overall survival
Tuesday 9 March 2010
Location
Denmark
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.
Recentin fails to meet primary endpoint in cancer trial
Monday 8 March 2010
Location
United Kingdom
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.
Roche and Biogen Idec suspend RA trials with ocrelizumab
Monday 8 March 2010
Location
Switzerland
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.
EMA seeks to work with government payers
Monday 1 March 2010
Location
United Kingdom
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.
FDA approves Shire product for Gaucher disease
Monday 1 March 2010
Location
United States
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.
FDA accelerates review of Shire product
Wednesday 24 February 2010
Location
United Kingdom
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.
FDA gives Novartis MS drug priority review status
Monday 22 February 2010
Location
United States
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.
EMA recommends conditional approval of GSK cancer drug
Monday 22 February 2010
Location
United Kingdom
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.
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Recent Appointments
Catherine Bréchignac to join Sanofi-Aventis board
Monday March 8 2010
Ulf Jönsson joins PharmaDiagnostics
Monday March 8 2010
Jan van Heek appointed non-executive director at Amarin
Monday March 8 2010
Thomas Hecht to become chairman of Cytos Biotechnology
Monday March 8 2010
Benoît Battistelli elected president of the EPO
Monday March 8 2010