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News Breaks
June 27, 2014
06:25 EDTRHHBYEU backs wider use of Roche's Avastin
Roche announced that the EU Committee for Medicinal Products for Human Use recommended that the European Commission approve the use of Avastin in combination with chemotherapy as a treatment for women with ovarian cancer that is resistant to platinum-containing chemotherapy. Ovarian cancer has the highest mortality rate of all gynaecological cancers. Of the 230,000 women diagnosed worldwide each year many will have advanced disease that will return after initial treatment. The new EU filing was based on results of the phase III AURELIA study which involved women with recurrent, platinum-resistant ovarian cancer who received either chemotherapy or Avastin added to chemotherapy. Results showed that at a median follow-up of 13 months for women who had received chemotherapy alone and 13.9 months for those who had received the combination, the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling the median PFS from 3.4 months to 6.7 months. AURELIA is the fourth phase III study of Avastin in ovarian cancer to show that adding Avastin to chemotherapy significantly increased the time women with ovarian cancer lived without their disease getting worse.
News For RHHBY From The Last 14 Days
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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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July 21, 2015
07:05 EDTRHHBYOphthotech names Shima as Chief Scientific Officer, Bjarke as CCO
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July 20, 2015
07:33 EDTRHHBYInternational AIDS Society to hold a conference
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05:13 EDTRHHBYRoche expands HIV Global Access Program
Roche announced an expansion to the HIV Global Access Program to include early infant HIV diagnostic testing for low and middle income countries. Roche, in partnership with the Joint United Nations Programme on HIV/AIDS, or UNAIDS, the Clinton Health Access Initiative, or CHAI, UNITAID, the U.S. President's Emergency Plan For AIDS Relief, or PEPFAR, and the Global Fund to fight AIDS, TB and Malaria, is committed to working with the Diagnostics Access Initiative by providing state-of-the-art solutions to achieve the 90-90-90 goal set forth by UNAIDS. Announced in 2014, the HIV Global Access Program is Roche's most recent addition to the AmpliCare Initiative, which launched in 2002 in South Africa.

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