My Clinical Trials Diary

News item: Source BioSpectrum, Asia Edition Singapore, Nov 4, 2010: Sanofi Pasteur, the vaccines division of Sanofi-aventis Group, has announced that its dengue vaccine is in final stage of clinical development. Sanofi Pasteur’s dengue vaccine, the world’s most clinically advanced dengue vaccine candidate entered its first phase III clinical study in Australia.  This study is part of a global phase III clinical study program aimed at advancing the development of a novel vaccine for the prevention of dengue disease in children and adults. Currently, there is no specific treatment available for dengue fever, which is a threat to nearly three billion people and a public health priority in many countries of Latin America and Asia where epidemics occur.  Phase III studies are the ultimate steps in the clinical development of a vaccine before it is submitted to regulatory authorities for evaluation for market authorization. Sanofi Pasteur’s candidate dengue ...

After tests revealed too-rapid release of active ingredient about one million fentanyl patches for chronic pain have been recalled from store and pharmacy shelves. Approximately one million fentanyl patches for chronic pain have been recalled from store and pharmacy shelves. The U.S. Food and Drug Administration and drug maker Actavis Inc. are working to get the word out, but they are targeting retailers and wholesalers, not consumers. Continue reading