Guidant
This article was originally published in The Gray Sheet
Executive Summary
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)...
You may also be interested in...
Guidant Insignia Entra
Single-sensor version of the Insignia Plus pacer line debuts in the U.S. Feb. 17. The device offers 110 seconds of dual-channel electrogram storage, the most currently available on the market, according to Guidant. Insignia was first approved in March 2002 and launched worldwide in June (1"The Gray Sheet" April 1, 2002, In Brief)...
Medtronic InSync ICD Gains Panel Support In Tiebreaking 6-5 Vote
The recommended post-market requirement for Medtronic's InSync ICD and its pacing counterpart suggests that companies that conduct pivotal studies with a small number of patients will be expected to follow up with a large trial
Guidant Has All Its Eggs In Paclitaxel-Coated Basket...For Now
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