SAFE-BioPharma and the Clinical Data Interchange Standards Consortium (CDISC) have announced they will collaborate to advance the electronic exchange of information across the global biopharmaceutical and health care communities. Specifically, the two groups are developing a specification to enable the CDISC operational data model (ODM) to accept SAFE digital signatures via the XML Advanced Electronic Signatures (XAdES) standard.

Sanofi-Aventis fired CEO Gerard Le Fur and picked a new CEO, hiring Chris Viehbacher, a longtime GSK executive who had been passed over in that firm’s search for a top executive, which colleague Andrew Witty won. In a release, the French company said: “The research and development of major innovative products, which remains one of the indispensable means of growth, must be better adapted to the new regulatory and economic constraints of the markets.”  Hard to argue with that.

Kforce Clinical Research has won Merck’s “Outstanding Operational Award in Clinical Development” as part of Merck’s 2007 Supplier Recognition Awards. Kforce was one of 13 suppliers to be recognized at the pharmaceutical company’s annual supplier recognition forum. Kforce provides customized and flexible functional outsourcing solutions. It specializes in clinical monitoring, site and study management, drug safety, clinical data management, data entry, clinical programming and biostatistics. Here’s the release.

Microsoft Internet Explorer has long been criticized by web developers for its indifference to web standards. Now the most popular web browser has another flaw, an internet legend alleges. Tim Berners-Lee was quoted making a pitch for images in SVG format. Those images are supported natively in some browsers. But an Adobe plug-in to read those images will not be further developed early next year. Hat tip to Web Guild. 

Contrary to public statements 27 months ago, Bristol-Myers Squibb pulled the antibiotic Tequin for reasons of safety and efficacy, the FDA says. (BMS had maintained that poor sales were the reason the drug was withdrawn.) For its part, the FDA said it will approve no ANDAs related to the drug. The Federal Register notice is a rare FDA assertion of inaccurate statements by a leading firm in the industry. The FDA also implicitly endorses the sometimes controversial role of Public Citizen in the early identification of drug safety issues. Hat tip to Tom Lamb’s Drug Injury legal blog.

Separately, Accenture won a $550 million contract from Bristol-Myers Squibb. It expands an existing relationship between the two firms and involves general business systems. Paul von Autenried, vice president and CIO at Bristol-Myers Squibb, said: “This agreement enables us to continue to leverage Accenture’s capabilities to improve our productivity and support our strategic transformation to a next-generation biopharma company.”

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