December 5th 2017 : EMA - Platform for post-authorization studies registered as EU trade mark (EUTM)
The European Union Intellectual Property Office (EUIPO) approved the registration of ‘EU PAS Register’ as a European Union trade mark (EUTM) in July 2017, marking the official launching.
The project aims to be accessible and transparent to all current and future Member States of the European Union. Moreover, the EU PAS (Post Authorization Studies) Register helps to facilitate peer-review of protocols and results, and ensures compliance with EU pharmacovigilance legislation requirements.
1,145 studies have already been registered, among which 50% were requested by European authorities. EUTM is internationally recognized as a post-authorization studies platform.
Furthermore, foreign researchers are encouraged to enrich the content of the platform by publishing their own studies.
24th November 2017 : The Nextep team is pleased to show you our posters presented at ISPOR 20th Annual Congress : click on the images below
December 5th 2017 - Controversy on efficacy of cancer medicines
A study published on October 4th, 2017 on the BMJ, reports that 57% of cancer drugs approved by the EMA had shown no improvement in survival or quality of life for patients.
This article, featuring an editorial by Prof. Vinay Prasad, who is known for being very critical in the past on the cost / benefit ratio of these products, was published in several media giving rise to many reactions.
The European Medicine Agency stated that the outcomes of the study were not surprising. Indeed, Francesco Pignatti, Head of Oncology, Hematology and Diagnostics at the European Medicines Agency, declared that in many situations, demonstrating a clear effect on survival or QoL is not feasible and benefits can be shown by other endpoints.
He concluded by emphasizing that, while the objective was obviously to have the most robust data methodologically, restricting approvals of cancer drugs may deprive patients in urgent need of early access to effective medicines.
Furthermore, the European Federation of Pharmaceutical Industries and Associations (EFPIA) regretted that the study fueled controversy about medicine price, without addressing the real benefits of cancer drugs. The EFPIA highlighted major progress in oncology driven by advancing science and innovative therapies.