MEDICAL TECHNOLOGY MANUFACTURERS SURPASS $1 BILLION PAYMENT TO IRS FOR DEVICE TAX

Washington, D.C. – The Medical Imaging & Technology Alliance (MITA), the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) today announced that medical device manufacturers have now paid an estimated $1 billion to the Internal Revenue Service for the medical device excise tax. In reaching this threshold, the device tax has denied device manufacturers the resources that would have otherwise been available to invest in research and development (R&D), capital investments and to support good-paying jobs across America.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