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News Breaks
June 10, 2014
16:05 EDTRHHBYHealth Canada approves Roche's HPV test for screening cervical cancer
Roche announced that Health Canada approved the cobas 4800 HPV Test for use as a first-line primary screening test for cervical cancer in women 25 and older. Roche has also launched the fully automated CINtec PLUS test to improve the detection and early intervention of pre-cancerous cervical disease. The Health Canada approved CINtec PLUS cytology test helps identify women with high-grade pre-cancerous cervical lesions who need immediate colposcopy. Roche's portfolio of cervical cancer screening products provides the most comprehensive strategies for cervical cancer prevention and treatment. The cobas 4800 HPV Test provides both pooled high-risk HPV DNA results and individual detection of HPV 16 and HPV 18, the two types responsible for about 70% of cervical cancer. Health Canada's decision to approve the expanded use for the cobas 4800 HPV Test was based on results from the landmark ATHENA trial, which enrolled more than 47,000 women. The study demonstrated that one in four women who are HPV 16 positive will have cervical disease within three years and that nearly 1 in 7 women with normal Pap cytology who were HPV 16 positive actually had high-grade cervical disease that was missed by cytology.
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July 31, 2015
06:36 EDTRHHBYImmunoGen: enrollment in expansion cohort for IMGN853 to complete by year end
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July 30, 2015
09:25 EDTRHHBYLeerink life science tools analyst holds an analyst/industry conference call
Life Science Tools & Diagnostics Analyst Leonard, along with Dr. Anami Patel and Dr. Nathan Ledeboer, discuss their perspectives on Point-of-Care molecular tests including the opportunity in virology / microbiology, the threat to traditional lab-based testing and point-of-care instruments on an Analyst/Industry conference call to be held on July 30 at 11 am.
05:57 EDTRHHBYRoche submits filing to FDA for companion diagnostic for NSCLC drug therapy
Roche announced it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval, or PMA, to the FDA, as a companion diagnostic test for AZD9291, an AstraZeneca (AZN) investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation. Patients with non-small cell lung cancer who have adenocarcinoma with tumor containing an EGFR sensitizing mutation show significant benefit from currently available EGFR TKI therapies. However, approximately two-thirds of these patients will relapse and develop drug resistance. In many cases, this resistance is caused by an acquired mutation called T790M. The cobas EGFR v2 test can aid clinicians to appropriately select NSCLC patients who have acquired the T790M mutation and are most likely to benefit from AstraZeneca's novel therapy.
July 28, 2015
07:08 EDTRHHBYRoche introduced several diagnostic testing platforms at the AACC 2015
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July 23, 2015
06:27 EDTRHHBYRoche CEO expects biosimilars in Europe by late 2017, Reuters reports
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05:46 EDTRHHBYRoche expects FY15 sales to grow low- mid-single digits
Expects FY15 core EPS to grow ahead of sales at constant exchange rates. Roche expects to further increase dividend in Swiss francs.
05:45 EDTRHHBYRoche reports 1H15 core EPS CHF 7.22 vs. 7.57 last year
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