Europe

EMA, FDA reinforce collaboration on patient engagement

Tuesday, June 28, 2016

The EMA and the FDA have set up a new ‘cluster’ on patient engagement. The cluster will provide a forum to share experiences and best practices on the way the two agencies involve patients in development, evaluation and post-authorization activities related to medicines.

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Ombudsman calls for more transparency

Tuesday, June 14, 2016

The European Ombudsman, Emily O’Reilly, has welcomed increased transparency in the clinical testing of Humira, one of the world’s biggest selling drugs, following her inquiry into the publication of clinical study reports.

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NIHR invests $23.4M in pediatrics research

Tuesday, May 31, 2016

A significant number of children experience long-term health conditions. This group’s health needs have not previously been given the research priority that they deserve. The NIHR has invested £21 million ($23.4 million) in 35 new studies focusing on improving the health outcomes for children and young people.

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Pfizer showcases results from two phase III TRUMENBA studies

Monday, May 16, 2016

Pfizer has announced results of two phase III studies demonstrating the immunogenicity of TRUMENBA (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the U.S. and Europe. The two studies, one in adolescents and one in young adults, met all primary immunogenicity endpoints. Also, secondary data presented show that TRUMENBA demonstrated similar immune responses against ten additional MnB strains, in both adolescents and young adults.

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Veristat acquires UK-based CRO Spero Oncology

Monday, May 2, 2016

Veristat, a full service CRO, is expanding its clinical research offerings into Europe through the acquisition of U.K.-based CRO Spero Oncology. Spero Oncology specializes in providing clinical operations support for oncology clinical trials primarily throughout Europe, but also in Australia and New Zealand. With the acquisition of Spero Oncology, Veristat now offers its clients full clinical operations support in Europe including feasibility studies, legal representation in the European Union, clinical monitoring, project management, protocol writing and regulatory strategy.

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Clinical research in India: Despite setbacks, opportunity continues

Monday, May 2, 2016

India has 16% of the world’s population and accounts for 20% of the world’s disease burden, yet less than 1.4% of global clinical trials are conducted there. A series of blemishes in clinical research has shaken worldwide confidence—but experts say positive steps have been taken to bring hope for the future.

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