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The Top Medical Device Stories of 2004

Executive Summary

In Vivo revisits the top stories impacting the medical device industry in 2004: Concentric and Cyberonics evidence an increased scrutiny on clinical data; the merger of J&J and Guidant rocks the cardiovascular industry; the FDA approval of Roche's Amplichip CYP450 paves the regulatory pathway for a new generation of clinical diagnostic tests based on microarrays; cardiac rhythm management expands to congestive heart failure patients; the first FDA approvals for stroke devices; in spine, the first FDA approval of the total artificial disc; and investigations and prosecutions by the Department of Justice strike at the heart of the device industry.

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Elephant Cha-Cha: The J&J/Guidant Deal

If you want some sense of the magnitude of Johnson & Johnson's recently announced acquisition of Guidant Corp., consider this: the $25.4 billion price tag was more than six times larger than any other deal done in the medical device space over the past six years; Still, if device industry executives were amazed by the deal, they weren't surprised. J&J's play for Guidant had been rumored for years-driven, it was argued, by a logical desire on the part of J&J to build on a valuable cardiovascular device business by accessing a major cardiac rhythm management (CRM) business. But it was the vascular business of both companies that seemed to propel the merger beyond the talking stages, beginning most notably, with the deal J&J and Guidant signed earlier this year to co-promote Cordis' Cypher drug-eluting stent. However, for all of the promise implicit in the merger of these two giants, there are enormous integration issues to be addressed, both before and after the deal closes. And for now, precisely how these challenges are resolved is likely to be fraught with uncertainty.

Probiotics’ Efficacy Too Specific For General Look In ’60 Minutes’ Segment Critical Of Category

A recent segment of CBS News “60 Minutes” discussing potential health benefits from probiotics was highly criticized by groups including the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the International Probiotics Association.

Stada Will Continue To Invest To Drive Growth

After a 12-month period that has seen Stada make significant investments in generics, biosimilars and consumer healthcare, CEO Peter Goldschmidt tells Generics Bulletin that the firm does not intend to stop there, as it pursues both organic and inorganic growth opportunities.

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