Johnson & Johnson selected ArisGlobal as its drug safety solution, a significant endorsement for the pharmacovigilance software house.  “With ArisGlobal’s ARISg robust feature set, flexible data model, intuitive user interface and ability to integrate with our key systems, Johnson & Johnson will incorporate this solution into our existing enterprise-wide processes, knowing that they have the ability to perform enhancements at an efficient pace,” said William Truhe, vice president of informatics, benefit risk management at Johnson & Johnson.

eResearchTechnology (eRT), an electronic data capture and cardiac monitoring company, is launching a new line of business: electronic patient reported outcomes (ePRO). The unit will initially concentrate on the central nervous system (CNS) therapeutic area. The company is partnering with Healthcare Technology Systems (HTS), an authority in the research, development and validation of computer administered clinical rating instruments. As part of its relationship with HTS, eRT will have rights to future products developed by HTS for use in Phase I-IV clinical trials and in other areas of clinical research. HTS was founded by renowned University of Wisconsin psychiatrists and settled an intellectual property lawsuit with ClinPhone in November of 2006.

GSK has lost 21 percent of its market share for diabetes blockbuster Avandia, with prescriptions written falling precipitously. The data are from research firm IMS. An unknown number of individual and class-action lawsuits have been filed against GSK, but legal experts say it will be difficult to prove Avandia caused cardiac problems, which are commonly associated with diabetes. Since late May, when an accusatory NEJM article on Avandia was published, investors have hacked approximately $16 billion from GSK’s stock market capitalization.

The FDA took the rare step of objecting to a House version of the law that could reauthorize spending for the Prescription Drug User Fee Act (PDUFA). Randall Lutter, FDA deputy commissioner for policy, told Congress the bill could make matters worse by duplicating existing FDA efforts: “Such changes could limit access to needed medicines and slow down new innovations while doing little to address the core issues of drug safety,” Lutter said.

Sparta Systems announced a beta version of TrackWise eMDR Submission Manager. Among other things, the add-on software enables medical device companies to electronically submit medical device reports (MDRs) to the Food and Drug Administration (FDA). Sparta was asked by FDA to participate in its eMDR pilot program. Collaborating closely with the agency, Sparta has developed standard functionality within TrackWise that allows customers to electronically transmit MDRs through the FDA’s Secure Gateway. “FDA’s eMDR Program and the TrackWise eMDR Submission Manager enable our medical device customers to improve their adverse event reporting processes by eliminating paper forms and manual document routing,” stated Mike Jovanis, director, solutions architecture at Sparta. “TrackWise increases efficiency while approving accuracy of information, providing a better and more effective product safety process, which ultimately benefits consumers and patients.”

The name of PhRMA‘s CEO, Billy Tauzin, has been leaked to the news media in the investigation of a Congressman charged with bribery. Rep. William Jefferson, whom FBI agents have been pursuing for some time, counted Tauzin (a fellow Congressman during the period under investigation) among his friends. Tauzin’s name has not been included in any of the formal court filings, indicating prosecutors assume he was not directly involved in anything that Jefferson is accused of. But some news accounts suggest there is a possibility Tauzin may have to testify at Jefferson’s trial.

Medidata Solutions announced that the Drug Information Association (DIA) will give Earl Hulihan, vice president of global regulatory affairs and quality assurance, the DIA’s Founders Service Award. The award recognizes individuals who have advanced the mission, vision and values of DIA and fostered the growth and development of the organization through their sustained dedication, time and effort.

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