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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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January 29, 2015
12:00 EDTRHHBYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analyst Schwartz discusses Biogen Idec BIIB037 and whether 2015 will be the year when Amyloid Beta is finally validated as a disease-modifying target in Alzheimer's Disease on an Analyst/Industry conference call to be held on February 3 at 2 pm.
05:47 EDTRHHBYRoche, Qualcomm collaborate on remote patient monitoring
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January 28, 2015
08:07 EDTRHHBYRoche unit receives orphan status for alectinib
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05:49 EDTRHHBYRoche sees 2015 sales growth in low- to mid-single digit
Roche expects sales to grow low- to mid-single digit, at constant exchange rates for 2015. Core earnings per share are targeted to grow ahead of sales at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.
05:48 EDTRHHBYRoche reports 2014 core EPS CHF14.29 vs. CHF14.27 last year
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January 27, 2015
14:00 EDTRHHBYRoche to hold a meeting with a conference call hookup
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January 26, 2015
05:15 EDTRHHBYRoche receives FDA clearance for next generation cobas MRSA/SA test
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January 23, 2015
08:17 EDTRHHBYRoche management to meet with JPMorgan
Meeting to be held in New York on January 29 hosted by JPMorgan.
January 21, 2015
09:02 EDTRHHBYRoche's Ventana seeks FDA premarket approval for ALK IHC lung cancer assay
Roche Group member Ventana Medical Systems announced its FDA submission for premarket approval of the Ventana ALK CDx Assay. The companion diagnostic immunohistochemistry test is designed to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy that inhibits the ALK gene. This submission was the fourth and final module and application required by the FDA's PMA process.
January 16, 2015
16:36 EDTRHHBYMarket finishes week lower on continued oil, global growth worries
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06:21 EDTRHHBYRoche acquires Trophos for EUR120M plus contingent payments
Roche has agreed to acquire Trophos, a privately held biotechnology company based in Marseille, France. Trophos’s proprietary screening platform generated olesoxime, TRO19622, which is being developed for SMA – a rare and debilitating genetic neuromuscular disease that is most commonly diagnosed in children. Results from a pivotal phase II clinical trial with olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with the disease. These data were first presented in April 2014 at the annual meeting of the American Academy of Neurology. Under the terms of the agreement, Trophos’s shareholders will receive an upfront cash payment of EUR 120M, plus additional contingent payments of up to EUR 350M based on achievement of certain predetermined milestones.

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