For patients with severe forms of epilepsy who don’t respond to other medications, hopes are high for marijuana as a treatment. But clinical data showing how well the drug works — and how safe it is — are sparse, experts say. Two clinical trials underway at the Jacobs...
CLINICAL RESEARCH Blog
Israeli Biotech Firm Starts Clinical Trials on Blood Test for Alzheimer’s
An Israeli NeuroQuest biotech firm has launched clinical trials on its blood-based biomarker test to detect Alzheimer’s disease. NeuroQuest announced last month they had entered into a service agreement with the University of California, San Diego for collection and...
Lack of drug safety data is putting Aboriginal lives at risk, says report
A lack of data on the safety of medicines for indigenous Australians is putting their health at risk, experts say. Writing in the latest Medical Journal of Australia, Dr Tilenka Thynne, from Flinders Medical Centre, and Dr Genevieve Gabb, from the Royal Adelaide...
FDA signs research agreement to build drug safety analysis platform
To improve the speed and quality of analysis of drug safety analysis, the Food and Drug Administration is partnering with Commonwealth Informatics to make it easier for its reviewers detect and investigate safety signals during new drug application reviews and...
Low participation raises concern for cancer clinical trials
When Lee Giller’s breast cancer returned in November 2012, he faced a prognosis of 26 months to live. So the 58-year-old Akron businessman, whose estrogen-receptor-positive and BRCA 1 breast cancer had spread to his bones, liver and lungs, said it “didn’t take much...
EU MAHs Will See Relief on Some Pharmacovigilance Updates
Beginning 1 February, drug companies operating in the EU will only have to update a database for some pharmacovigilance changes and will no longer have to submit a particular IA variation to the European Medicines Agency (EMA). Read more: raps.org