News Briefs: FDA Turns Down Wright’s Augment; Cook Resumes Zilver PTX Shipments; Luminex Restructures
This article was originally published in The Gray Sheet
Wright Medical receives not approvable letter for its Augment bone graft asking for another study. Judge rules against Zimmer in favor of Strkyer in patent case. Cook Medical has resolved the problems that triggered a December 2012 recall of its Zilver PTX peripheral stent. Luminex cuts staff, invests in molecular diagnostics efforts.
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The US Supreme Court will consider arguments on what standards should be met if an award in a patent violation case is to be increased due to willful infringement. A District Court judge tripled a $70 million award Stryker was granted against Zimmer for infringement in a jury trial, but the award was reduced on appeal.
The agency has agreed to accept Wright Medical’s PMA amendment for its embattled Augment bone graft, saving the firm from going to a dispute resolution panel this spring.
The acquisition of Biotech International is intended to provide Wright with a complementary extremity product portfolio and to significantly expand Wright’s direct sales channel in France and international distribution network for foot and ankle products.