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News Breaks
June 10, 2014
08:16 EDTBCRFDA posts 12-month results of C.R. Bard Levant 2 trial
The FDA posted on its website briefing documents ahead of a circulatory system devices panel meeting scheduled for June 12, where an advisory committee will review C.R. Bard's Lutonix drug-coated balloon PTA catheter. Among the documents posted was C.R. Bard's executive summary, which contains the 12-month results of its pivotal Levant 2 trial. "Freedom from TLR was numerically favorable for the Lutonix DCB group, but no statistical difference between arms in Freedom from TLR rates was observed," the company stated in the summary. Reference Link
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November 26, 2014
14:28 EDTBCRMedtronic agrees to divest Covidien drug-coated balloon catheter business
Medtronic (MDT) has agreed to divest the drug-coated balloon catheter business of Covidien (COV) in order to settle Federal Trade Commission charges that its $42.9B acquisition of Covidien would likely be anticompetitive. Under the FTC’s proposed settlement, Medtronic will sell the drug-coated balloon catheter business to medical device company Spectranetics (SPNC), the FTC announced. According to the FTC’s complaint both Medtronic and Covidien are developing drug-coated balloon catheters to compete with C.R. Bard (BCR), which currently is the only company that supplies these products, used to treat peripheral artery disease, in the U.S. market. Medtronic and Covidien are the only companies with products in clinical trials in the Food and Drug Administration’s approval process, which makes it unlikely that other competitors could enter the market in time to counteract the effects of the merger, the FTC alleges. The Commission vote to accept the proposed consent order for public comment was 5-0. The FTC will publish the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through December 29, after which the Commission will decide whether to make the proposed consent order final.

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