Siemens Healthcare Diagnostics Inc. will develop diagnostics to aid the development of new Pfizer Inc. medicines and potentially market companion diagnostics linked to commercialized Pfizer drugs under an agreement between the two firms announced Dec. 16. Siemens will be one of multiple companion diagnostic collaborators with Pfizer. The agreement “marks a major milestone in Siemens’ personalized medicine strategy,” Trevor Hawkins, senior VP, strategy and innovations, in Siemens Healthcare’s diagnostics division, said in a statement. Pfizer, as with other big pharma companies, is increasingly partnering with diagnostics firms on its pipeline projects. For instance, the firm gained FDA approval of its Xalkori (crizotinib) lung cancer drug in 2011 in partnership with Abbott Laboratories Inc., which gained simultaneous approval for its Vysis ALK fluorescence in-situ hybridization companion assay. (See Also see "Team Work: Pfizer, Abbott Gain Swift Approvals For Lung Cancer Drug/Test Combo" - Medtech Insight, 5 September, 2011..)
FDA granted de novo approval to Xlumena Inc.’s Axios stent and delivery system for treating pseudocysts, which are cavities filled with fluid and tissue that form in the pancreas, the agency announced Dec 18. FDA has previously approved stents for pancreatic drainage, but says that this is the first stent specifically designed for drainage of pseudocysts in the pancreas by creating a new, temporary opening between the pancreas and the gastrointestinal tract. Current stents are placed in the pancreas’ existing ducts. Axios is a fully-covered stent with bilateral anchors that is delivered under endoscopic ultrasound guidance. It can be removed once the pseudocyst is drained
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