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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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November 27, 2015
09:25 EDTRHHBYRoche management to meet with JPMorgan
Meetings to be held in Jersey City/New York on December 1 and in Connectciut/New York on December 2 hosted by JPMorgan.
November 22, 2015
15:14 EDTRHHBYExelixis confirms Phase 3 data on Cotellic with Zelboraf for melanoma
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15:09 EDTRHHBYGenentech reports data on Cotellic with Zelboraf for treatment of melanoma
Genentech, a member of the Roche Group, announced data from the pivotal coBRIM study, showing that Cotellic, or cobimetinib, in combination with Zelboraf, or vemurafenib, helped people with BRAF V600E and V600K mutation-positive unresectable or metastatic melanoma live "significantly longer" than with Zelboraf alone, according to the company. Cotellic plus Zelboraf reduced the risk of death by 30% compared to Zelboraf alone and helped people live a median of nearly two years, with 74.5% of BRAF V600 patients alive at one year and 48.3% alive at two years. Ongoing study monitoring did not identify any new safety signals. The company noted that an approval decision on Cotellic from the European Commission is expected before year end.
November 18, 2015
08:28 EDTRHHBYLeerink to hold a bus tour
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08:11 EDTRHHBYIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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November 17, 2015
07:34 EDTRHHBYOphthotech to hold a conference call
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06:08 EDTRHHBYRoche subsidiary to participate in Ophthotech and Novartis agreement
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November 13, 2015
10:18 EDTRHHBYRoche receives FDA approval for cobas EGFR mutation test
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09:34 EDTRHHBYFDA approves Roche's cobas EGFR Mutation Test
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