Yola Moride will serve the EMEA as a national expert at the EMEA’s London offices. She’s a bigshot. Moride was recently voted president-elect of The International Society for Pharmacoepidemiology (ISPE). She holds appointments as Adjunct Professor at McGill University, Visiting Professor at the University of Bordeaux, and as Project Director…more...

A new database made its debut this week, with little U.S. fanfare. EMEA Executive Director Thomas Lönngren said of the EudraPharm resource: “Once fully developed, this database will be the reference point for independent information about all medicines available to Europeans, no matter whether these medicines have been authorised at…more...

Ted Agres of The Scientist has a very nice review of the recent machinations around drug safety. The article is an attempt to predict what will happen when the new Congress convenes. The article suggests that details of a new drug safety environment are being worked out behind the scenes.…more...

Amgen says it is trying to rebut idle misinformation and gossip about the safety of a blockbuster product. Specifically, without mentioning the publication, it is angry about the fallout in response to research published in the New England Journal of Medicine in mid-November. Doctors are noticing that two clinical trials,…more...

In a rapid and painful decision, Pfizer killed torcetrapib. The New York giant suspended all development of the compound and what was believed to be the most expensive clinical Phase III trial in history, the “Illuminate” study. With a budget of $800 million and 15,000 patients recruited, the trial had…more...

A major Canadian research project, led by Bruce Carleton and Michael Hayden, will attempt to improve drug safety for children. The effort today received a major contribution of $500,000 from Pfizer Canada. The Genotype-Specific Approaches to Therapy in Childhood (GATC) receives major funding from a Genome Canada/Genome BC-sponsored research program…more...

The November 23, 2006 New England Journal of Medicine (NEJM) has a blistering article and editorial on Bayer’s handling of data around Trasylol (aprotinin). In that case, the company has launched an internal investigation and has reprimanded two employees, as this website (and others) reported earlier this fall. The NEJM…more...

The current issue of Forbes, dated November 27, has a cover story on medical devices by Matthew Herper and Robert Langreth. The title: “Dangerous Devices.” The heart of the story is about safety problems with medical devices. It tries to tie such problems to the device industry’s less rigorous path…more...

In the two years since Vioxx was withdrawn from the market, there have been few specific indications from the FDA about how to improve the system for monitoring drug safety. Now the agency has spoken at a conservative think tank, the Manhattan Institute. There’s a wire service story about a…more...

There’s a major potential new source of drug safety data from the federal government. The outgoing head of the CMS branch of Dept. of Health and Human Services (HHS), Mark McClellan, is trying to tie up a few loose ends before leaving Washington. We’ve just stumbled on a mid-October announcement…more...