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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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December 25, 2014
07:28 EDTRHHBYRoche announces FDA approval of sBLA for Gazyva
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December 19, 2014
16:31 EDTRHHBYOn The Fly: Closing Wrap
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12:27 EDTRHHBYOn The Fly: Midday Wrap
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11:32 EDTRHHBYRoche acquires privately held Bina Technologies
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09:48 EDTRHHBYBiogen should be bought on weakness after Roche drug halted, says Evercore ISI
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09:28 EDTRHHBYOn The Fly: Pre-market Movers
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08:53 EDTRHHBYBiogen drug, trial differs from Roche Alzheimer's drug, says RBC Capital
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08:51 EDTRHHBYBiogen drops 2% after Roche discontinues Alzheimer drug trial
Shares of Biogen (BIIB) are moving lower after Roche (RHHBY) announced the discontinuation of its Alzheimer's drug gantenerumab, which was in Phase III testing. Analysts at Wells Fargo said Roche's trial failure adds risk to Biogen's potential treatment of Alzheimer's. Shares of Biogen are down $8.20 to $345.50 in pre-market trading.
06:12 EDTRHHBYRoche says breast cancer study did not meet PFS superiority endpoint
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06:10 EDTRHHBYRoche to discontinue Phase III study of Alzheimer's disease drug
Roche announced the decision to discontinue SCarlet RoAD, a phase III study of investigational anti-amyloid medicine gantenerumab in prodromal Alzheimer’s disease, based on results of a pre-planned futility analysis and recommendation by the independent Data Monitoring Committee. No new safety signals for gantenerumab were observed in this analysis and the overall safety profile was similar to that seen in the phase I trial, Roche said. Data from the SCarlet RoAD study will be shared with the medical community after full review and analysis, it added. "We are disappointed with these study results because people with early stage Alzheimer's need new medicines that delay disease progression,” said Sandra Horning, M.D., Chief Medical Officer at Roche. "This is the first Phase III trial to evaluate a potential disease-modifying medicine in this early prodromal stage of Alzheimer’s disease. We remain committed to investigating new medicines for this devastating illness."
05:36 EDTRHHBYImmunoGen reports Phase III MARIANNE study met non-inferiority endpoint
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05:33 EDTRHHBYGenentech provides update on Phase III MARIANNE
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December 18, 2014
12:46 EDTRHHBYRoche acquires privately held Dutalys for $133.75M up front
Roche announced that it has agreed to acquire Dutalys GmbH, a privately held biotechnology company based in Vienna, Austria. Dutalys specializes in the discovery and development of fully human, bi-specific antibodies based on their proprietary DutaMab technology, Roche said. Under the terms of the agreement, Roche will make an upfront cash payment of $133.75M to shareholders and make additional contingent payments of up to $355M based on the achievement of certain predetermined milestones.
December 16, 2014
08:47 EDTRHHBYHemispherx Ampligen provides anti-tumor activity
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05:46 EDTRHHBYRoche launches PCR molecular diagnostic system for point of care environment
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December 15, 2014
05:24 EDTRHHBYExelixis announces Genentech files NDA for cobimetinib, vemurafenib combination
Exelixis (EXEL) announced its collaborator Genentech, a member of the Roche Group (RHHBY), has completed the filing of its New Drug Application, or NDA, with the FDA for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. Cobimetinib has received Fast Track designation by the FDA. Roche submitted a Marketing Authorization Application for the combination to the European Medicines Agency in September of this year. The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial conducted by Genentech in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.

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