The FDA announced a new project to study drug safety. The FDA is not officially involved in the effort, but heralded the Predictive Safety Testing Consortium all the same. The consortium combines the efforts of Arizona’s quasi-governmental C-Path Institute and five pharmaceutical companies. They’ll share internally developed laboratory methods to… more...

A key FDA whistle-blower has been ordered to testify. Dr. David Graham once publicly estimated that Merck’s painkiller Vioxx had caused 160,000 heart attacks and strokes. The FDA had sought to block Graham’s testimony, but lost that motion in federal court yesterday. Like the big drug company, the FDA is… more...

Eleven people have been killed in a nine-nation, 24-week clinical trial sponsored by Japan’s Eisai. The drug, Aricept, is for Alzheimer’s disease and is co-marketed with Pfizer.  The clinical trial was testing Aricept in patients with dementia traced to vascular problems. The drug is not approved for that indication in… more...

ProSanos Corporation, a company specializing in the capture, integration and analysis of healthcare-related data, announced today the receipt of a Phase I Small Business Innovation Research (SBIR) grant from the Department of Defense (DOD). The grant will be used for research to apply ProSanos’s drug safety technology to DOD needs.… more...

Pharsight’s Senior Scientist Yuying Gao, M.D., Ph.D., will speak to members of the Japanese pharmaceutical industry attending the 28th mini-symposium of the Department of Molecular Pharmacokinetics, to be held at the University of Tokyo on March 23, 2006. Dr. Gao will give a presentation on the strategic value of quantitative… more...

Phase Forward appointed J. Jay Volkert as manager of its government division at its Lincoln Technologies subsidiary. The company said Dr. Volkert has 25 years of experience in providing consulting and IT services to federal health care agencies. “Dr. Volkert’s extensive experience in the federal and health care sectors will… more...

Affymetrix and Iconix will combine their efforts to provide tools to assess drug toxicity. The collaboration will combine Affymetrix’ GeneChip microarray technology with Iconix’ DrugMatrix 640 compound reference database and analysis software. Affymetrix’ arrays and Iconix’ analysis tools could provide detailed information on a drug candidate’s toxicological liabilities and pharmacological… more...

Software from TheraDoc (of Utah) and BioMetrieux (of France) is having an impressive effect on patient health. The two companies say their Stellara package, used for clinical intervention and patient monitoring, was used at Franciscan Health Systems in Tacoma, Washington. “We have experienced tremendous success with Stellara as our intelligent… more...

Genzyme has stopped enrolling patients in a mid-stage heart cell therapy clinical trial on a recommendation that the study has a low likelihood of success. The study’s data monitoring committee suggested the trial’s hypothesized improvement in heart function would not be likely, given a review of data so far. The… more...

European regulators will write simple versions of drug safety bulletins. In technical parlance, the EMEA says, summaries of European public assessment reports (EPARs) will be intended for ordinary patients. Each summary will have explanation of how the drug works, what ailments it should be used for, how it was studied,… more...