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 […]
Global report - September 5, 2014
GE Healthcare gets EU approval of VIZAMYL
VIZAMYL has received marketing authorisation from the European Commission for PET imaging of beta amyloid plaque in suspected Alzheimer’s disease. It will be commercially available in selected European countries from early 2015. When used in conjunction with a clinical evaluation, using VIZAMYL to detect the accumulation of beta amyloid in the brain may help to confirm an Alzheimer’s […]
Global report - August 29, 2014
Ebola vaccine to be tested
GlaxoSmithKline plans to take its ebola vaccine candidate to clinical trials and test it in Great Britain, Gambia and Mali. A candidate Ebola vaccine could be given to healthy volunteers in the UK, The Gambia and Mali as early as September, states GSK, as part of a series of safety trials of potential vaccines aimed […]
Global report - August 11, 2014
Pfizer faces legal threat over Lipitor
Cases of women claiming Lipitor gave them diabetes is increasing. In 2012, lawsuits concerning Pfizer’s cholesterol fighter Lipitor began as the FDA announced a warning that statins, a type of cholesterol lowering medicines, could have negative effects on memory and could also give a slightly increased risk of developing type 2 diabetes. The number of […]
