Regulation & Policy

Actelion receives FDA complete response letter for Zavesca

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.

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Ark Therapeutics drops Cerepro appeal

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.

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Zalutumumab fails to meet primary endpoint of overall survival

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.

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Recentin fails to meet primary endpoint in cancer trial

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.

 

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Roche and Biogen Idec suspend RA trials with ocrelizumab

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.

 

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EMA seeks to work with government payers

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.

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FDA approves Shire product for Gaucher disease

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.

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FDA accelerates review of Shire product

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.

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FDA gives Novartis MS drug priority review status

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.

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EMA recommends conditional approval of GSK cancer drug

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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