Improving Drug Warning Systems at UA

UA Pharmacists Lead National Effort to Improve Drug Warning Systems.  Nearly every pharmacy and hospital in the U.S. relies on drug warning systems, and most physicians soon will, too. Yet such systems still have some weaknesses, which UA pharmacists are working to address.Continue reading

U.S. Food and Drug Administration and European Medicines Agency Reach Landmark Decisions on Critical Path institute’s Clinical Trial Simulation Tool for Alzheimer’s Disease

In a big step forward for Alzheimer’s disease (AD) therapy development, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have independently reached favorable decisions on the value of Critical Path Institute’s new disease simulation tool for improving trial design in mild and moderate Alzheimer’s disease. The first such instrument to ever receive this regulatory designation, the tool represents an enabling advance to improve the design of future clinical trials in AD. The new tool applies computerized models to simulate “what-if” scenarios for clinical trials.

The goal of this virtual tool is to serve as a public resource for sponsors designing trials of new therapies for AD.Continue reading

Calimmune Initiates HIV Stem Cell Study at Two California Research Sites

CalimmuneLogoThe HIV gene medicines company, Calimmune,  announced today that the first patient has begun treatment in a Phase I/II clinical trial designed to determine whether a pioneering genetic medicine approach can help to protect individuals infected with HIV from the effects of the virus. The study, “Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection,” utilizes a gene medicine called Cal-1, developed in the lab of Nobel Laureate Dr. David Baltimore and by Calimmune.Continue reading