Clinical Trial

Cost-Benefit Ratio – EMA to harmonise HTA processes

04.11.2010

London – While looking for a successor to EMA Executive Director Thomas Lönngren, the agency has opened a debate on a hot topic for biopharmaceutical companies and health technology assessors – defining the rules for what kinds of evidence must be provided to determine a drug candidate’s risk-benefit balance and its economic value. Although the EMA says it is not aiming to establish a Euro-NICE, more harmonisation could lower hurdles for drug developers in reaching EU markets. It could also bring down R&D costs for candidate drugs in early development.
AstraZeneca, GlaxoSmith­Kline and Johnson & Johnson are now funding a four-month pilot discussion looking at diabetes treatment that will include clini­cians, health technology assessors, pa­tient groups, payers, regulators and drug developers from France, Germany, Italy, the Netherlands, Sweden and the UK. Partici­pants believe the experiment could help shape subsequent pilots, and broaden initiatives for early consultation. How­ever, recommendations from the October meeting and two further discussions will be non-binding.
Advice for the developers of novel medicines is urgently needed in markets where pressure to control healthcare costs is on the rise. The EMA has been working closely with HTA bodies since 2008 to determine how clinical trials must be designed to provide data that allow evaluation of the risk-benefit ratio of a compound, as well as the comparison of a drug’s relative effectiveness and benefit-cost ratio.

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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