Clinical Trial

Xarelto meets phase III endpoint

20.08.2011

Berlin – Bayer Healthcare’s oral factor Xa blocker Xarelto (rivaroxaban) has met the primary endpoint of non­inferiority to warfarin in a Phase III safety study involving 1,280 Japanese patients, half of whom suffered from attrial fibrillation (AF). Around 800,000 Japanese have been diagnosed with the condition. Besides improved safety, the company also intends to demonstrate prevention of stroke and embolism in patients with these indications, and submitted an MAA in April to Japanese and EU regulatory authorities. At a dose of 15mg once daily, the bloodthinner reduced the risk of embolism by 51% compared to warfarin, even though the study wasn’t designed at statistically demonstrating efficacy, according to Bayer.

Politics / Law

06.03.2012

London – The European Medicines Agency (EMA) calls it “the biggest change to the legal framework since the establishment of the Agency in 1995.” This year, the EU drug regulators are preparing new so-called pharmacovigilance...

Clinical Trial

06.03.2012

Norway’s Algeta ASA (Oslo) has updated its Phase III survival analysis of Alpharadin in patients with castration-resistant prostate cancer and bone metastases. The analysis showed an increase of 3.6 months in median overall...

Clinical Trial

06.03.2012

Genticel S.A. (Toulouse) has completed enrolment in its Phase Ib study of a lyophilised version of the world’s very first therapeutic vaccine ProCervix, which inhibits infection with the cancer-causing Human Papilloma Virus. The...

Clinical Trial

06.03.2012

The share value of French specialist for cardiometabolic diseases Genfit S.A. (Loos/Lille) took a jump after the company announced its candidate drug GFT505 had met all efficacy endpoints in a pilot Phase II study involving 22...

Clinical Trial

06.03.2012

The US Food and Drug Administration (FDA) has granted a Biologics License Application (BLA) to the HER2 dimerisation inhibitor pertuzumab developed by Roche (Basel) for previously untreated HER2­-positive metastatic breast...

Politics / Law

06.03.2012

A For years, the world’s major patent offices – including the EPO, USPTO and JPO – have been collaborating in the Patent Prosecution Highway (PPH) programme. Under the PPH, an applicant whose claims have been allowed in one...

BioFunding

06.03.2012

Berlin/Dublin – Two EU initiatives are seeking to better predict response to cancer treatments. Researchers from the a6m RESPONSIFY Project will develop biomarker-based breast cancer prognosis tests that could be used to predict...

BioFunding

06.03.2012

Bremen/Brussels – European researchers kicked-off the MicroB3 (Bio­diversity, Bioinformatics, Biotechnology) project in February. Thanks to a a9m EU fund, the 32 groups involved will create a unique bioinformatic resource that...

BioFunding

06.03.2012

A Brussels – The European Commission is boosting its investments and policy activities to foster sustainability. “Europe needs to make the transition to a post-petroleum economy,” said Máire Geoghegan-Quinn in Brussels. In...

Politics / Law

06.03.2012

Brussels – In February, I heard of a slightly mad and very worrying trend in decisions handed down by the Court of Justice of the European Union (CJEU) with regard to IP issues handed up from the national level for clarification....

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No liability assumed, Date: 17.04.2014

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