In Nevada, a jury ordered Wyeth to pay $135 million to three women who took Premarin and Prempro. The jury said Wyeth acted with malice or fraud. Wyeth has no reserve fund for its hormone replacement therapy (HRT) cases, possibly because it has spent tens of billions of dollars to settle fen-phen litigation. The jury apparently was not convinced by the company’s defense, which was that its warning labels on the drugs do mention breast cancer. News accounts hint the ruling will be appealed by the company or tossed out by the judge, but additional jury deliberations made it impossible for anyone to say that openly yesterday. The blogosphere notes the company faces more than 5,000 similar suits. Investors shrugged off the news. Here’s a nice sentence stolen from the Wall Street Journal’s Sarah Rubenstein: “Deutsche Bank drug analyst Barbara Ryan said that it is too early in the string of litigation to presume this case would be the start of a trend, and that in general the hormone-replacement cases appear tougher for plaintiffs to win than past fen-phen diet-drug litigation.”
Phase Forward, a top clinical trial technology platform, announced enhancements to its electronic data capture (EDC) application. Specifically, its InForm Integrated Trial Management (ITM) EDC solution has new electronic clinical data management (eCDM) functionality. The release includes new navigational features, customizable work flow filters and support for the Oracle 10g database and Cognos 8 Business Intelligence. Noting its centralized design, coding and interoperability modules, Martin Young, Phase Forward’s VP of corporate development, said: “The enhancements in this new release underscore our commitment to providing the solutions designed to meet sponsor organizations’ need to improve productivity and increase cost savings.”
Contract research organization (CRO) INC Research, which moved from San Diego, California, to North Carolina seven years ago, said it plans to invest $19.2 million in real estate. That will include a new corporate headquarters in Wake County, North Carolina by 2011. About half a dozen companies have announced plans to create at least 200 jobs in the state in 2007, including top CRO Quintiles Transnational. Together, PRA International, Quintiles and INC expect to create 2,500 jobs over the next few years. “This is good news for this county, this state, and we’re excited about it,” North Carolina governor Mike Easley said at a news conference.
bioRASI, a contract research organization, has moved its headquarters to Hollywood, Florida, where it plans to hire at least 45 employees. The company signed a $250,000 qualified target industries business incentive deal. Chairman Boris Reznik said he is eager to work with the technology transfer departments of local universities, such as Florida Atlantic University and Nova Southeastern University. The company is a spin-off of the Russian Academy of Sciences, the world’s oldest research organization.
California’s Phoenix Software International announced a major new release of its electronic data capture (EDC) system for clinical trials, known as Entrypoint Plus 3.0. Important new features include remote data entry, context-sensitive help to the dialog box level, and enhanced security. John Brayman, head of the Entrypoint Plus development team, said: “The software was introduced in 1981 and was among the first products available for EDC. Entrypoint Plus is the software of choice for clinical research organizations that have been using EDC since the technology began.” This is a different company, for the record, than Philadelphia’s Phoenix Data Systems, which also makes EDC software.
Beijing-based SkinGenix will be using TAKE Solutions’ life sciences document management solution, the PharmaReady electronic Document Management Solution (eDMS) and electronic Common Technical Document (eCTD) submission solution. This will help with document consistency and U.S. FDA regulatory compliance. “Efficient, accurate document management and global regulatory compliance were the main criteria in our solution search,” said Irene Huang, project manager with SkinGenix. “PharmaReady’s eDMS and eCTD system meets those needs, and the web-based application will enable our researchers to access key documents from virtually any location.” SkinGenix is a subsidiary of MEBO International, a Beijing-headquartered, multinational company specializing in regenerative medical research and health product development.
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