EUROCARE 5 results where presented at the European Parliament on 5 December 2013. Some of the conclusions were: • The number of adults survive at least 5 years after diagnosis has increased steadily over time in all regions of Europe from 1999 to 2007 , BUT STILL cancer survival varies widely between European countries.
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…
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.
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Pomalidomide (Pomalidomide Celgene®) has been granted a licence for use in myeloma patients across Europe. This decision by the European Commission follows the positive recommendation in May 2013 for pomalidomide by the Committee for Medicinal Products for Human Use (CHMP), within the European Medicines Agency (EMA).
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®.
Smouldering myeloma patients are generally not treated until symptoms develop. The current standard of care is observation. Previous attempts at treating smouldering myeloma with older treatments such as alkylating agents either were not effective or led to concerns about long-term toxicity.
Phase III Study (MM-020/IFM 07-01) of Oral REVLIMID® (Lenalidomide) in Newly-Diagnosed Multiple Myeloma Meets Primary Endpoint
Statistically significant improvement in progression-free survival demonstrated On Thursday 11 July 2013, Celgene International Sàrl announced that its phase III study (MM-020/IFM 07-01) of REVLIMID® (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival (PFS). In the study, a doublet regimen of continuous oral lenalidomide in combination with low-dose dexamethasone (Rd) demonstrated a statistically significant improvement in PFS compared to patients receiving a comparator arm…