European Medicines Agency

LONDON, 10-12-2015 — /EuropaWire/ — AstraZeneca today announced plans to test a digital support service for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of cediranib plus olaparib. Voluntis has developed the service in close clinical … Read the full press release →

Executive Director appointed for five-year term LONDON, 20-11-2015 — /EuropaWire/ — Professor Guido Rasi has taken office as Executive Director of the European Medicines Agency (EMA) today. Professor Rasi was nominated as Executive Director for a five-year mandate by the … Read the full press release →

EMA veterinary committee sets objectives to limit risks arising from use of antimicrobials in animals LONDON, 20-11-2015 — /EuropaWire/ — The European Medicines Agency has released for public consultation a new strategy on antimicrobials for 2016-2020 adopted by its Committee … Read the full press release →

Deadline to submit expressions of interest to represent civil society at PRAC andCAT to European Commission extended until 18 October LONDON, 1-10-2015 — /EuropaWire/ — The Health and Food Safety Directorate-General of the European Commission has extended the deadline for … Read the full press release →

ADAPT SMART PARIS, 30-9-2015 — /EuropaWire/ — EURORDIS is partnering in the recently launchedADAPT SMART* project, which will establish a platform that enables the coordination of Medicines Adaptive Pathways to Patients (MAPPs) activities. MAPPs can help to ensure access to … Read the full press release →

LONDON, 14-7-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has started a review of HPV vaccines to further clarify aspects of their safety profile. These vaccines have been used in around 72 million people worldwide and their use is … Read the full press release →

EMA publishes workshop report on requirements for the authorisation of vaccines LONDON, 14-7-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has published today the outcome of a workshop which explored how to ensure the availability of veterinary vaccines in … Read the full press release →

Promacta® (eltrombopag) significantly increased and sustained platelet counts in two studies, including the largest Phase III clinical trial in this patient population Characterized by a low platelet count[1], ITP can affect up to 5 in 100,000 children each year[2] and … Read the full press release →

EMA invites feedback on its new draft guideline LONDON, 22-5-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has released a draft guideline on quality, non-clinical and clinical aspects of gene therapies for a three-month public consultation. The document aims … Read the full press release →

EMA to host workshop on therapeutic use of bacteriophages LONDON, 22-5-2015 — /EuropaWire/ — The European Medicines Agency (EMA) will host a workshop on the use of bacteriophages to treat bacterial infections on 8 June 2015. The workshop will be … Read the full press release →

Companies encouraged to submit expressions of interest LONDON, 23-4-2015 — /EuropaWire/ — The deadline for submitting expressions of interest to participate in the information-sharing initiative for generics has been extended to give more time to companies to submit their applications. … Read the full press release →

Registration now open for a workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) on 28 May 2015 LONDON, 9-4-2015 — /EuropaWire/ — Enpr-EMA will hold its 7th annual workshop on 28 May 2015 at … Read the full press release →

Polycythemia vera (PV) is associated with overproduction of blood cells that can cause serious cardiovascular complications, such as stroke and heart attack[1] Clinical data show Jakavi® (ruxolitinib) significantly improved hematocrit levels and reduced spleen size, key measures of disease control[2] … Read the full press release →