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News Breaks
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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July 24, 2014
06:13 EDTRHHBYRoche reaffirms outlook for 2014
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06:12 EDTRHHBYRoche reports 1H core EPS CHF 7.57 vs. CHF 7.58 last year
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July 23, 2014
09:08 EDTRHHBYUltragenyx appoints Sunil Agarwal, M.D. as Chief Medical Officer
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July 22, 2014
05:21 EDTRHHBYRoche announces Genentech Avastin granted priority review by FDA
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July 21, 2014
07:11 EDTRHHBYInternational Society of DNA Vaccines to hold a conference
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06:43 EDTRHHBYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 20, 2014
15:42 EDTRHHBYRoche not looking for big acquisitions, Reuters says
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July 17, 2014
17:42 EDTRHHBYCepheid says Roche patent suit will not have material adverse impact on results
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July 16, 2014
11:23 EDTRHHBYRoche Alzheimer drug shows mixed results in trial, NYT says
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06:26 EDTRHHBYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
05:37 EDTRHHBYGenentech Avastin granted priority review by FDA
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July 14, 2014
11:20 EDTRHHBYExelixis seen as potential target for Roche, TheStreet says
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July 10, 2014
10:02 EDTRHHBYRoche unit, Merck KGaA to develop companion test for cancer treatment
Ventana Medical Systems, a member of the Roche Group (RHHBY), announced it has entered into an agreement with Merck KGaA (MKGAY), which operates as EMD Serono in the United States and Canada, to collaborate with Merck KGaA's biopharmaceutical division on the development and commercialization of a companion diagnostic for an undisclosed target using Ventana's proprietary diagnostic assays.

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