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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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June 30, 2015
05:30 EDTRHHBYGenentech reports ocrelizumab Phase III studies met primary, secondary endpoints
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June 25, 2015
14:03 EDTRHHBYRoche initiated with a Buy at HSBC
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June 24, 2015
09:07 EDTRHHBYCAR-T cancer drug researchers seen as M&A targets, Bloomberg says
Juno Therapeutics (JUNO), Kite Pharma (KITE) and Bluebird Bio (BLUE) are trading well above their IPO levels as takeovers predictions have spurred interest and share increases for the developers of CAR-T gene therapies, said Bloomberg's "Real M&A" column, quoting Dimo Dimov, a professor at the University of Bath’s School of Management, as having said that companies such as Pfizer (PFE), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are "closely watching" the firms. Cellectis (CLLS), which is working with Pfizer on its own approach to CAR-T therapy, has said it wants to bring its therapy to market and doesn’t anticipate a sale, the report noted. Reference Link
June 17, 2015
07:14 EDTRHHBYProthena announces PRX002 was safe, well tolerated
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