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News Breaks
October 23, 2012
07:48 EDTRHHBYRoche alleged non-compliance with pharmacovigilance obligations probed by EMA
The European Medicines Agency has started an infringement procedure against Roche Registration Ltd, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicines. The initiation of the infringement procedure follows a pharmacovigilance inspection carried out in 2012 by the UK Medicines and Healthcare products Regulatory Agency, which identified serious shortcomings of Roche’s pharmacovigilance processes. The start of this procedure means that the Agency will further investigate the allegations against Roche, though it does not prejudge the outcome of the investigation. The Agency will report the outcome of its investigation to the European Commission who may impose fines or periodic penalty payments under the Regulation mentioned above if it finds that Roche has committed an infringement of its obligations.
News For RHHBY From The Last 14 Days
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July 29, 2014
09:09 EDTRHHBYRoche to hold an investor update
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08:15 EDTRHHBYEnzo Biochem announces August 18 as date of Markman hearing in lawsuit
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05:58 EDTRHHBYExelixis shares rallied on Roche rumors, says Piper Jaffray
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July 28, 2014
07:30 EDTRHHBYQ1 Productions to hold a conference
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July 25, 2014
07:35 EDTRHHBYEMA recommends new indication for RoActemra in severe arthritis
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July 24, 2014
06:13 EDTRHHBYRoche reaffirms outlook for 2014
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06:12 EDTRHHBYRoche reports 1H core EPS CHF 7.57 vs. CHF 7.58 last year
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July 23, 2014
09:08 EDTRHHBYUltragenyx appoints Sunil Agarwal, M.D. as Chief Medical Officer
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July 22, 2014
05:21 EDTRHHBYRoche announces Genentech Avastin granted priority review by FDA
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July 21, 2014
07:11 EDTRHHBYInternational Society of DNA Vaccines to hold a conference
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06:43 EDTRHHBYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 20, 2014
15:42 EDTRHHBYRoche not looking for big acquisitions, Reuters says
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July 17, 2014
17:42 EDTRHHBYCepheid says Roche patent suit will not have material adverse impact on results
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July 16, 2014
11:23 EDTRHHBYRoche Alzheimer drug shows mixed results in trial, NYT says
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06:26 EDTRHHBYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
05:37 EDTRHHBYGenentech Avastin granted priority review by FDA
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