Global report - October 6, 2014
EMA adopts open trial data policy
The European Medicines Agency (EMA) has decided to publish the clinical reports that underpin the decision-making on medicines. The new landmark policy will take effect on 1 January 2015. It will apply to clinical reports contained in all applications for centralised marketing authorisations submitted after that date. The reports will be released as soon as […]
Drug Development Pharma - August 5, 2014
EMA looks to stimulate better use of genomic data in medicines development
The agency is taking a look at better use of genomic data and biomarkers in medicines development and safety monitoring. The European Medicines Agency has released a draft concept paper for public consultation outlining the key elements that will be developed in a guideline on good genomics biomarker practices. The concept paper proposes a framework for the generation […]
Collaboration - November 28, 2013
New European collaboration on vaccine
Several leading organizations are joining forces to launch a project to improve benefit and risk assesments of vaccines. The project will pave way for a pan-European framework for rapidly assessing and communicating the benefits and risks of vaccines. The hope is that the framework could make it easier for regulators and public health authorities to […]
Drug Development Pharma - August 6, 2013
Green light for diabetes treatment
The European Medicines Agency, EMA, has concluded that GLP-1 based treatments do not pose new safety concerns for patients with type 2 diabetes. Earlier this year, a study was published that indicated that drugs based on GLP-1 increase the risk of developing pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia. GLP-1, glucagon-like-peptide-1, is a […]
Clinical Trials - April 29, 2013
62 percent of patients recruited outside of Europe
A recent analysis from the European Medicines Agency shows that 62 percent of the patients in pivotal trials were recruited outside of the European Economic Area. The report on clinical trials submitted in MAAs to the European Medicines Agency, published on April 9th, provides an overview of the distribution of the numbers of patients, investigator […]
