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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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November 30, 2015
10:05 EDTRHHBYRoche management to meet with JPMorgan
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November 22, 2015
15:14 EDTRHHBYExelixis confirms Phase 3 data on Cotellic with Zelboraf for melanoma
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15:09 EDTRHHBYGenentech reports data on Cotellic with Zelboraf for treatment of melanoma
Genentech, a member of the Roche Group, announced data from the pivotal coBRIM study, showing that Cotellic, or cobimetinib, in combination with Zelboraf, or vemurafenib, helped people with BRAF V600E and V600K mutation-positive unresectable or metastatic melanoma live "significantly longer" than with Zelboraf alone, according to the company. Cotellic plus Zelboraf reduced the risk of death by 30% compared to Zelboraf alone and helped people live a median of nearly two years, with 74.5% of BRAF V600 patients alive at one year and 48.3% alive at two years. Ongoing study monitoring did not identify any new safety signals. The company noted that an approval decision on Cotellic from the European Commission is expected before year end.
November 18, 2015
08:28 EDTRHHBYLeerink to hold a bus tour
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08:11 EDTRHHBYIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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November 17, 2015
07:34 EDTRHHBYOphthotech to hold a conference call
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06:08 EDTRHHBYRoche subsidiary to participate in Ophthotech and Novartis agreement
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