This week, cardiologists are attending the Transcatheter Cardiovascular Therapeutics (TCT) meeting. And an online news organization covering the sessions, MedPage, reports interventional cardiologists are trying to sort out conflicting claims about stents. Peer-reviewed journals and regulatory agencies have been posting reports of significantly higher complication rates for the devices. Now…more...

Pegus Research selected DSG’s eCaseLink EDC software to conduct a Population Safety Trial (PST) to evaluate the safety of a prescription drug. The trial is being conducted for an unidentified top 10 pharma. Clients at the Utah-based Pegus, a pharmacoepidemiologic contract research organization (CRO), include some of the largest sponsors…more...

Gene Logic inked a drug repositioning and development agreement with Lilly. In a press release, the companies say Lilly will use Gene Logic’s tools to see if dead compounds can be resuscitated. All of the drug candidates in question have been discontinued or de-prioritized in clinical trials for reasons other…more...

Bayer is rushing to appease the FDA. It has suspended two unnamed employees and retained a high-profile Washington lawyer to launch an internal probe into why preliminary data about Trasylol, a protease inhibitor, was not submitted to the agency before a public advisory meeting in late September. Bayer now says…more...

Who should pay attention to the Institute of Medicine(IOM)? Clearly, the FDA is. The IOM, as many readers may recall, offers intelligent, thorough, well-documented reports that invariably become conversation starters in Washington. It would be foolish to question the labor, insight and time that go into any IOM report. But…more...

Wire service reports suggest Germany’s SAP, locked in a battle with Oracle over domination of the corporate enterprise, is negotiating to acquire a stake in Aris Global. That American company, based in Connecticut, is declining to comment. There are no indications of the likelihood or price for the acquisition at…more...

The Cleveland Clinic picked Steven Nissen to be interim head of cardiovascular medicine, anointing formal replacement for Eric Topol, a vehement critic of the pharmaceutical industry. (Topol is leaving the Cleveland Clinic for its crosstown rival, Case Western University.) Nissen is unlikely to view the industry through rose-colored glasses: he…more...

Australian officials are considering a new physician role in clinical trials. The goal is to avoid the TeGenero debacle in London. Australians will have certain physicians coordinate patient care. The pilot program starts on January 20, 2007 and appears to be a way for primary care physicians to dip their…more...

Public Citizen is lobbying the FDA to ban Xenical, an anti-obesity drug made by Roche. The drug is also about to be sold over-the-counter by Glaxo SmithKline. Public Citizen is a Washington lobbying group affiliated with Ralph Nader and, while mostly ignored within the industry, Public Citizen provided early and…more...

Lawyers suing Merck have put together a way to lower the cost of attacking the drug company. The pre-packaged Vioxx workbook can shave the cost of suing Merck from $1 million to just $50,000. There are already 10,000 cases pending against the company, but the new arrangement could open the…more...