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Guidant Has All Its Eggs In Paclitaxel-Coated Basket...For Now

This article was originally published in The Gray Sheet

Executive Summary

Guidant's decision to halt its in-house actinomycin-D drug-eluting stent program raises the stakes of an upcoming court ruling on whether Cook violated a 1997 co-exclusive agreement between Angiotech Pharmaceuticals and Boston Scientific

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FDA Panel Review Of J&J Cypher Stent Will Weigh SIRIUS Late Loss Data

Johnson & Johnson/Cordis' upcoming presentation before an FDA advisory panel on the Cypher drug-eluting stent will highlight a 67% reduction of target vessel failure (TVF) at nine months compared with bare stents

FDA Panel Review Of J&J Cypher Stent Will Weigh SIRIUS Late Loss Data

Johnson & Johnson/Cordis' upcoming presentation before an FDA advisory panel on the Cypher drug-eluting stent will highlight a 67% reduction of target vessel failure (TVF) at nine months compared with bare stents

Guidant

Co-exclusive licensing agreement with Novartis Pharma AG will allow Guidant to use the investigational everolimus drug on coronary stents. Clinical trials evaluating a coronary stent with the compound, which is in the same family as Rapamycin (sirolimus), are slated to begin by year-end. Guidant previously disclosed it was working on an "unnamed compound" in addition to its paclitaxel program through an agreement with Cook (1"The Gray Sheet" March 11, 2002, p. 15). Separately, Guidant announces FDA market go-ahead for its Insignia next-generation pacemaker on March 26. FDA approval of the firm's Contak CD system for heart failure patients needing resynchronization therapy is expected "within the next several weeks," Guidant notes. FDA's Circulatory System Devices Panel recommended against approval in July 2001, but Guidant submitted additional data in February (2"The Gray Sheet" March 11, 2002, p. 3)...

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