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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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October 24, 2014
12:03 EDTRHHBYRoche reports CHMP recommends label update for Esbriet
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October 21, 2014
07:15 EDTRHHBYFDA to hold workshop on breast cancer drug development
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October 20, 2014
12:37 EDTRHHBYOn The Fly: Midday Wrap
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07:19 EDTRHHBYIBC Life Sciences to hold a conference
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07:11 EDTRHHBYAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTRHHBYAmerican Society of Human Genetics to hold annual meeting
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07:06 EDTRHHBYNewLink announces worldwide license agreement for NLG919 development
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07:04 EDTRHHBYRoche approval would be positive for TESARO, says Jefferies
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October 16, 2014
14:47 EDTRHHBYRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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13:13 EDTRHHBYRoche considers submitting Ebola test for emergency use approval, WSJ says
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09:35 EDTRHHBYDiplomat announces contract to distribute Esbriet
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05:58 EDTRHHBYRoche sees FY14 core EPS targeted to grow ahead of sales
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05:56 EDTRHHBYRoche reports 9 month revenue CHF34.76B vs. CHF34.87B last year
Roche CEO Severin Schwan said: “Demand for our products is strong in both divisions and we are well on track to reach our full-year targets. We have had positive news from our product pipeline, including study results for Perjeta in breast cancer and a new combination therapy with Zelboraf in melanoma. The InterMune acquisition has also strengthened our portfolio with a new medicine, Esbriet for idiopathic pulmonary fibrosis, which has now been approved by the FDA. In Diagnostics, growth continues to be driven by the immunodiagnostics business and we have strengthened our molecular diagnostics portfolio with a new generation of testing systems.”
October 15, 2014
15:45 EDTRHHBYFDA approves Esbriet to treat idiopathic pulmonary fibrosis
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October 14, 2014
11:23 EDTRHHBYBIND Therapeutics and The Conference Forum hold a conference
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