Off-label promotion for dementia?
NYT: Lilly Hides Obesity Data on Zyprexa
The drug company denies any misconduct and hopes the controversy will go away.
The FDA is about to close its comment period for its new draft guidance on electronic "source," or master, versions of data in clinical trials. Should the agency implement and finalize that document in the coming years, there could be profound changes in the way that clinical data is collected by the pharmaceutical industry. The biggest potential change? Paper-based facts now filed away in boxes might become electronically accessible to FDA inspectors. With that prospect in mind, Clinical Ink is an interesting company at an interesting juncture in time. The firm is based in North Carolina and makes a $1,500 tablet for clinical trials. The device is being piloted in several small studies. It comes with preloaded medical dictionaries and proprietary software that decodes a user's handwriting in ways custom designed for industry-sponsored research. New Tool Clinical Ink president Ed Seguine formerly toiled in the venture capital and technology branches of…more...
One surprising aspect of the clinical trial landscape is just how few PhDs and physicians share their knowledge, either as industry insiders or academic researchers. The vastness of the global research…more...
As one of the more established companies providing electronic data capture (EDC), Phase Forward has only a handful of competitors of similar size and an impressive list of major customers. Just…more...
With the adoption of any new technology—from coal to lasers—lofty expectations are slowly eroded by the day-to-day reality of the technology in actual use. In the clinical trial landscape, the tool…more...
Do large pharmaceutical companies need to go back to the drawing board on matters like basic respect in their relationships with clinical sites? Kim Oliver of Sanofi Aventis thinks of it this way: “The pharmaceutical industry is under a lot of pressure to do things faster, and with less money and fewer resources. And it’s the same…more...
The way Eli Lilly interprets it, investigator relationship management (IRM)—the recent trend among sponsors to cater to clinical sites in order to keep them around—involves figuring out who the best sites are, and giving them plenty of work. Because sheer numbers of projects is what makes sites happy, says Jim Kremidas, the company’s director of global enrollment…more...
A federal judge in New York issued a stern but meaningless order concerning Lilly’s internal documents about the bipolar disorder drug Zyprexa. The judge forced a medical consultant and a lawyer to “return” thousands of sensitive documents to Eli Lilly. The losers in the ruling include David Egilman, a Vermont medical expert for Zyprexa plaintiffs, and James…more...
Doctors are trained to deliver bad news in a gentle, sensitive manner. Alan Breier, chief medical officer of Eli Lilly, may have missed that lecture. A psychiatrist and former academic, Breier took the podium at the Clinical Trials Congress in Las Vegas and bluntly declared that many of the major organ systems of pharmaceutical research are failing.…more...
The drug company denies any misconduct and hopes the controversy will go away.
The new arrangement with the U.S. company is mostly related to clinical trial data services, and the news release quotes the Indiana executive who oversees such matters.
Pauley charges that a DeWitt Publishing employee named Sharon Johnson represented herself as a New York Times reporter.
Lilly will share the rewards with technology company if failed drug candidates can be revived.
Shares in contract research organization Pharmaceutical Product Development (PPD) dropped 4 percent yesterday after the company said President Fred B. Davenport Jr. is leaving. Wall street analysts, however, are uniformly upbeat on the company’s prospects.
In its latest acquisition, for which no price was disclosed, the database giant did say that the new addition to its arsenal will be incorporated into the forthcoming “Fusion” project that combines all of its recent purchases.
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