In October 2008, called on the U.S aciphex.net . Food and Drug Administration with additional information before considering further HEPLISAV in end-stage renal disease patients, but noted outside the United States of risk to potential benefit no longer favors continued clinical evaluation of HEPLISAV in healthy adults and children. The clinical hold on the two U.S. IND Applications for HEPLISAV effective from March 2008, after the FDA requirements for a full review of safety data including all available information about a single case of Wegener’s granulomatosis have been reported in a Phase 3 clinical trial.
About HEPLISAVHEPLISAV is a Phase 3 hepatitis B vaccine, the HBV surface antigen combined with proprietary immunostimulatory Dynavax sequences , specifically to toll-like receptor TLR9 9 () stimulate an innate immune response. Clinical data show HEPLISAV the highly effective protection against HBV with rapid protection, superior 2 – dose and long-lasting seroprotection compared to current vaccines. In a recent Phase 3 trial, 95 percent of subjects. 2 doses of HEPLISAV compared to 81 percent of patients who received 3 doses of Engerix-B seroprotected Were carried out in 9 clinical trials over a period of almost 10 years, a total around 2,500 people , with more than 5,000 doses HEPLISAV have been vaccinated.
Research Councils UK The strategic partnership of seven United Kingdom Research Councils in the , which for investing each year? 3 billion for the UK research base, which of academic disciplines. Of academic disciplines. RCUK optimized the to work ways the Research Councils impact of the impact of Germany research, training and the transfer of knowledge.
The Director-General emphasized that all the action with the purpose and extent of International Health Regulations match.