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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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September 30, 2014
07:30 EDTRHHBYSachs Associates to hold a conference
14th Annual Biotech in Europe Forum for Global Partnering and Investment to be held in Basel, Switzerland on September 30-October 1.
September 29, 2014
08:11 EDTRHHBYRoche sees completing InterMune acquisition later today
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05:35 EDTRHHBYExelixis announces positive results from Phase 3 pivotal trial of cobimetinib
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September 28, 2014
12:49 EDTRHHBYRoche announces final survival results from Phase III CLEOPATRA study
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September 24, 2014
10:58 EDTRHHBYRoche to host conference call
Conference call to discuss new clinical data on Roche's oncology products and pipeline that were presented at the European Society for Medical Oncology's Annual Meeting will be held on September 29 at 4 am. Webcast Link
September 22, 2014
19:23 EDTRHHBYRoche management to meet with JPMorgan
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13:53 EDTRHHBYRoche launches $5.75B bond to back InterMune acquisition, Reuters reports
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September 20, 2014
15:43 EDTRHHBYInterMune reports MOU in connection with consolidated Delaware action
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September 17, 2014
11:00 EDTRHHBYRoche CEO rules out megadeals, focused on bolt-on acquisitions, WSJ says
Roche CEO Severin Schwan said the company won't change its acquisition strategy following the recent deals made or abandoned in the pharmaceutical sector, reports the Wall Street Journal. In an interview with WSJ, Shwan said, "We have been very consistent in our approach to M&A." Regarding transformational deal-making, he said, "We have no intention to do that, whatever happens in the industry." Reference Link
07:43 EDTRHHBYBofA/Merrill to hold a conference
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September 16, 2014
07:31 EDTRHHBYEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.

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