JAMA says no to preemption; Sanofi to expand in China;

> As the elections draw near, preemption will be on the forefront of pharma minds. Since on November 3, the U.S. Supreme Court will make some decisions on whether FDA safety and efficacy determinations will be the final word or not. It might be telling that the editors of JAMA now have formally opposed preemption. Report

> France's Sanofi-Aventis announced it will expand its research and development functionality in Shanghai, China. In a new partnership with the Shanghai Institutes for Biological Sciences, the company will work on drug discovery in the areas of cancer, diabetes and neurological disease, and will put a new biometrics facility in Beijing. Report

> The CEO of Pfizer, Jeff Kindler (photo), and its CFO, Frank D'Amelio (photo), had an interesting chat with Ed Silverman of Pharmalot, and said cost cutting will be an important strategy to increase profitability. Report

> The FDA gave Abbott Laboratories a response to its request for approval of an extended-release form of the popular painkiller, Vicodin, which was not positive. Abbott release l Report

> Researchers at Saint Louis University have developed a vaccine for tuberculosis that may offer better protection than the one currently in use. Report

> Pharmalot has been piecing together the likely fallout from Pfizer's move to restructure its R&D system. Sources are telling Pharmalot that layoffs will be "substantial," though there's no direct word on just what kind of numbers are to be expected. Report

> The FDA will extend its review of Pfizer's osteoporosis drug, Fablyn, through January 2009 "to allow the agency to fully review complete five-year data from the pivotal Pearl trial," a Pfizer spokesperson said. Report

> The FDA was unable to take final action on the New Drug Application (NDA) for milnacipran, Forest Laboratories' and Cypress Bioscience's selective serotonin and norepinephrine re-uptake inhibitor aimed at treating fibromyalgia. Report

> Roche is holding strong on its $43.7 billion bid to complete its Genentech acquisition, despite a 2 percent fall in sales to $29 billion in the last nine months. Release l Report

> After 10 years of work, Living Cell Technologies in New Zealand has received the green light from the government to launch an unusual human trial of a new diabetes therapy. Volunteers in the trial will be injected with pig cells, an approach the company believes will help to regulate the way their bodies produce insulin. Report

> A team of researchers at the University of Michigan have successfully tested a new approach to revving up the human immune system. Report

And Finally... An FDA panel of health experts voted to support approval for mass production of Genzyme's Myozyme for the treatment of Pompe disease, a rare muscle disorder that can lead to fatal respiratory problems.  The FDA panel members said, 16-1, that they felt the drug trials showed that the drug was effective, and most recommended accelerated approval of Myozyme, so long as Genzyme was diligent with follow up. Report

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