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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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February 25, 2015
07:18 EDTRHHBYG Corp to hold annual meeting
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06:14 EDTRHHBYPTC Therapeutics takeout price likely tops $100/share, said Credit Suisse
Credit Suisse yesterday raised its price target for PTC Therapeutics (PTCT) shares to $100 from $66 after Reuters reported the drug market is starting a sale process with Shire (SHPG) and Biomarin (BMRN) as possible suitors. The firm believes a takeout is a likely outcome before or after data the Phase III data expected to be announced in October. PTC has Translarna Phase III trials ongoing in Duchenne muscular dystrophy and cystic fibrosis to support full approval in the U.S. Credit Suisse said yesterday in a note to investors that a takeout value for the company likely exceeds $100 per share. It believes PTC would be a good fit for Vertex (VRTX), Biogen (BIIB), Roche (RHHBY) and others. The firm kept an Outperform rating on the stock. PTC Therapeutics shares closed yesterday up $6.20 to $71.16.
February 24, 2015
09:06 EDTRHHBYRoche receives orphan status for treatment of pemphigus vulgaris
The FDA granted Roche's Genentech unit orphan status for rituximab, its treatment of pemphigus vulgaris.
07:05 EDTRHHBYRoche and BioMed X enter collaboration agreement to develop sensor technology
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February 23, 2015
06:21 EDTRHHBYFacebook's shuttle drivers approve new union contract, WSJ reports
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February 20, 2015
16:48 EDTRHHBYDow, S&P 500 finish week at record highs after Greek deal reached
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07:23 EDTRHHBYAbbVie replaces Pfizer as top global pharma pick at Jefferies
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February 19, 2015
18:25 EDTRHHBYPiper Jaffray biotech analyst to hold analyst/industry conference call
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09:09 EDTRHHBYLeerink's life science tools analyst holds an analyst/industry conference call
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06:45 EDTRHHBYStudy shows Roche's treatments equal to Eylea in most cases, NY Times says
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05:31 EDTRHHBYExelixis announces acceptance of NDA for Genentech cobimetinib
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05:26 EDTRHHBYFDA grants Genentech cobimetinib priority review for combination use
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