EHA survey on unavailability of medicines

A website survey where doctors, patients and healthcare professionals can report unavailability of medicines has been developed. Over the course of (at least) the following months, these reports will be collected and analysed so that we can develop a coherent picture of the scope, causes and consequences of these problems in Europe. At the moment such an overview does not exist which makes it difficult for European politicians and policy makers to take measures that…

Lithuanian Presidency to start negotiations on clinical trials regulation

The Committee of Permanent Representatives (COREPER I) mandated the Lithuanian Presidency to enter into negotiations with the European Parliament and the Commission with the aim to reach an agreement at first reading on the Proposal for a Regulation on Clinical trials on medicinal products for human use, which aims to facilitate the conduct of clinical trials and thus increase their number in the EU, which could result in better treatment of patients.

Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders and changes to scope of European safety referrals

Amendments of the European Union (EU) pharmacovigilance legislation that were adopted in October 2012 came into force on Monday 28 October 2013. These changes, which cover various aspects of the legislation, aim to further strengthen the protection of patient health by increasing the ability of the European medicines network to take prompt and appropriate regulatory action.

Two new indications of Velcade® approved for use across Europe

The European Commission granted a licence for the use of two new indications of Velcade® (bortezomib) in the treatment of myeloma. It has approved its use as an induction treatment for newly diagnosed patients prior to high-dose therapy and autologous stem cell transplantation and as a retreatment in relapsed myeloma patients (in combination with thalidomide and dexamethasone) who have previously responded well to Velcade®.

CHMP positive opinion on Pomalidomide

The Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a marketing authorisation for Pomalidomide (Pomalidomide Celgene®) in the treatment of multiple myeloma for relapsed and refractory myeloma patients. The next step is for the European Commission to adopt the final licensing decision within three months. There is no doubt that this is a crucial step for patients within the EU…