Europe

AbbVie, Genomics Medicine Ireland and WuXi NextCODE partner

Monday, January 9, 2017

AbbVie, a global biopharmaceutical company, life-sciences startup Genomics Medicine Ireland (GMI), and WuXi NextCODE, a global contract genomics organization, has announced the launch of a long-term strategic alliance to conduct population genomics research in Ireland aimed at advancing the discovery and development of novel therapeutic approaches to a range of serious diseases. The 15-year collaboration will focus on major chronic diseases within oncology, neuroscience and immunology that affect hundreds of thousands of people in Ireland and hundreds of millions worldwide. Financial terms were not disclosed.

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EMA to offer advice for new biosimilars

Tuesday, December 20, 2016

The EMA will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. Through this new initiative, EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical and functional data they have already available for the medicine.

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Report: Clinical research benefits the U.K. economy

Friday, December 2, 2016

An independent report, commissioned by the National Institute for Health Research (NIHR) Clinical Research Network and produced by KPMG’s Economics team, provides an assessment of the economic impact of the NIHR Clinical Research Network’s activities to support clinical research in the U.K. The report includes assessment of the economic contribution made to the U.K. economy through clinical research activity supported by the network; analysis to quantify the value of payments made to NHS Trusts for commercial studies, and the value to the NHS of pharmaceuticals used as part of industry-sponsored studies.

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Three Questions: Dr. Stella Blackburn, QuintilesIMS

Monday, November 28, 2016

CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Dr. Stella Blackburn, vice president and global head of risk management for real-world evidence solutions at QuintilesIMS. As part of her efforts, Blackburn has been focused on the EMA’s adaptive pathways pilot program.

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The European Commission launches a public consultation on the Pediatric Regulation

Friday, November 18, 2016

The European Commission (EC) has launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Pediatric Regulation after nearly 10 years of implementation. The consultation is open until February 20, 2017. Stakeholders should send their comments directly to the EC by accessing the consultation page.

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EMA to revise first-in-human clinical trials guideline

Friday, November 18, 2016

The EMA, in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The revised guideline is open for public consultation until 28 February 2017. Comments should be sent to FIH-rev@ema.europa.eu using the template provided.

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