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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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October 20, 2014
12:37 EDTRHHBYOn The Fly: Midday Wrap
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07:19 EDTRHHBYIBC Life Sciences to hold a conference
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07:11 EDTRHHBYAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTRHHBYAmerican Society of Human Genetics to hold annual meeting
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07:06 EDTRHHBYNewLink announces worldwide license agreement for NLG919 development
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07:04 EDTRHHBYRoche approval would be positive for TESARO, says Jefferies
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October 16, 2014
14:47 EDTRHHBYRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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13:13 EDTRHHBYRoche considers submitting Ebola test for emergency use approval, WSJ says
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09:35 EDTRHHBYDiplomat announces contract to distribute Esbriet
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05:58 EDTRHHBYRoche sees FY14 core EPS targeted to grow ahead of sales
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05:56 EDTRHHBYRoche reports 9 month revenue CHF34.76B vs. CHF34.87B last year
Roche CEO Severin Schwan said: “Demand for our products is strong in both divisions and we are well on track to reach our full-year targets. We have had positive news from our product pipeline, including study results for Perjeta in breast cancer and a new combination therapy with Zelboraf in melanoma. The InterMune acquisition has also strengthened our portfolio with a new medicine, Esbriet for idiopathic pulmonary fibrosis, which has now been approved by the FDA. In Diagnostics, growth continues to be driven by the immunodiagnostics business and we have strengthened our molecular diagnostics portfolio with a new generation of testing systems.”
October 15, 2014
15:45 EDTRHHBYFDA approves Esbriet to treat idiopathic pulmonary fibrosis
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October 14, 2014
11:23 EDTRHHBYBIND Therapeutics and The Conference Forum hold a conference
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October 8, 2014
11:31 EDTRHHBYFDA grants priority review for Genentech's Lucentis
Genentech, a member of the Roche Group (RHHBY), announced that the U.S. FDA has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7M Americans. The FDA confirmed action date is February 6, 2015. The sBLA was submitted August 7 to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy. If approved by the FDA, Lucentis could be the first eye medicine available for diabetic retinopathy patients. The submission is based on results of the RISE and RIDE Phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with Lucentis at two years compared to patients treated with sham injections. Benefits of Lucentis treatment were maintained during year three of treatment. The safety in the RISE and RIDE Phase III trials was consistent with previous studies.
10:55 EDTRHHBYLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
07:19 EDTRHHBYCBI to hold a conference
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