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March 13, 2014
03:18 EDTRHHBYFDA advisory committee unanimously recommends Roche's cobas HPV test
Roche announced that the U.S. FDA Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas HPV Test as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks. The panel also voted unanimously that the cobas HPV Test is safe and effective for the proposed indication for use. If approved, the cobas HPV Test would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the United States. The Committee's recommendation will be considered by the FDA in its review of the primary screening indication for the cobas HPV Test. The FDA is not bound by the Committee's guidance, but takes its advice into consideration when reviewing medical devices.
News For RHHBY From The Last 14 Days
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September 22, 2014
19:23 EDTRHHBYRoche management to meet with JPMorgan
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13:53 EDTRHHBYRoche launches $5.75B bond to back InterMune acquisition, Reuters reports
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September 20, 2014
15:43 EDTRHHBYInterMune reports MOU in connection with consolidated Delaware action
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September 17, 2014
11:00 EDTRHHBYRoche CEO rules out megadeals, focused on bolt-on acquisitions, WSJ says
Roche CEO Severin Schwan said the company won't change its acquisition strategy following the recent deals made or abandoned in the pharmaceutical sector, reports the Wall Street Journal. In an interview with WSJ, Shwan said, "We have been very consistent in our approach to M&A." Regarding transformational deal-making, he said, "We have no intention to do that, whatever happens in the industry." Reference Link
07:43 EDTRHHBYBofA/Merrill to hold a conference
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September 16, 2014
07:31 EDTRHHBYEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
September 10, 2014
13:04 EDTRHHBYRoche unit receives orphan status for lung cancer mutation drug
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