Lilly chairman and CEO Sidney Taurel, in a speech at the Cleveland Clinic, says there should be a new, modern pharmacovigilance system. “Systems are now within our grasp to more quickly identify both the true benefits and the full extent of risks associated with medicines in widespread use,” he said. “The time is ripe for FDA, the health care industry, and the medical community to collaborate on a reform of our nation’s pharmacovigilance system. Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly.” Taurel told his audience of embryonic efforts to unite electronic health record (EHR) systems with those used in drug development. ClinPage is skeptical. The U.S. is too broke to finance improvements to the current extremely modest system for drug safety. Another Vioxx may have to erupt before Congress revisits the issue in earnest. Maybe the Canadians will build it…

Novo Nordisk, a speciality pharma company, is about to set up its global data management center in India. The Danish firm will use the Indian unit to collate clinical research data of drug trials for its international operations (IO) division. Novo Nordisk is also in the process of setting up the data management center in Bangalore. Novo Nordisk India managing director Melvin Oscar D’Souza said: “India is the second largest center for global clinical trials in Asia after China. About 10 percent of the IO region trial data is generated from India. Currently 8-9 drugs are under trial across 40 centers in India. India has also gained importance among the Asian nations as a clinical research market for Novo Nordisk.”

Arbios, a suburban Boston medical device concern, will launch an adaptive trial of its liver-assist device. The key quote from the press release: “ In response to the presentation of a pivotal trial design, the FDA provided the Company with comment and further indicated that a single pivotal study may be acceptable to the FDA.” The full news release is here.

Netrics, a provider of database record matching software, has announced a partnership with SigmaSoft International, a global supplier of data management software solutions for clinical trials. The two companies collaborated on a new auto encoder/browser for defining Medra and WHODrug terminology. The software can search tens of thousands of highly complex medical terms, spontaneously correcting human errors, and find correct matches instantly. Steve Colville, chief executive officer of SigmaSoft explained: “Netrics was the perfect fit, providing the best fuzzy search technology to deliver excellent results and also providing a solution that is affordable for small and mid-sized medical research companies.”

Holmes Biopharma, a contract research organization (CRO) focused on providing integrated clinical development services, announced that the 2007 revenue from its clinical research operations now exceeds $5 million. The company is presently expanding its facilities in Omaha, Nebraska, and has added a clinic in Kiev, Ukraine. With the addition of these operations, management expects sales to grow by 100% in 2008.

Pharma-Bio Serv, a provider of regulatory compliance and validation services, has announced the opening of an Irish affiliate to serve the Ireland and United Kingdom markets. Elizabeth Plaza, Pharma-Bio Serv’s chief executive officer, said: “The opening of our Ireland office confirms our commitment to meet our vision: To become world leaders in validation, regulatory compliance and technical support services, helping our clients meet the challenges of regulatory enforcement and globalization.”

Top FDA officials like Andrew von Eschenbach are being sued over the rejection of Provenge, a prostate cancer therapy. So says a legal website publishing a story with a few typographical errors and a bucket of serious charges. Among other things, the story alleges that several FDA reviewers with financial conflicts of interest were chosen to hurt Provenge’s developer, Dendreon, in order to boost the research efforts of Dendreon’s competitors and investors.

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