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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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April 23, 2014
06:16 EDTRHHBYPharmaceutical companies narrowing focus, WSJ reports
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April 21, 2014
12:44 EDTRHHBYRoche management to meet with Jefferies
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April 19, 2014
11:12 EDTRHHBYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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April 17, 2014
06:18 EDTRHHBYEMA warns that stolen Roche drug found on market
The European Medicines Agency has been informed that vials of the cancer medicine Herceptin, thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries. This is currently being investigated by Member State authorities and updates will be provided as more information becomes available. Italian law enforcement authorities are currently investigating the theft and are looking at whether other medicines may also be affected. No affected product has so far been identified at hospital level and there are no reports that any harm has come to patients in relation to the falsified medicine and authorities are working to avoid this. The marketing authorisation holder for Herceptin is Roche.
April 16, 2014
07:32 EDTRHHBYRegeneron may be taking market share from Roche, says Brean Capital
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April 15, 2014
09:02 EDTRHHBYRoche confirms FY outlook for low-to mid-single digit growth in sales
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09:01 EDTRHHBYRoche reports Q1 sales CHF11.496B vs. CHF11.589B a year ago
Roche reported Q1 group sales rose 5% at constant exchange rates and fell 1% in Swiss francs compared to the prior year. Pharma sales were up 4%, with continued growth of Avastin, MabThera/Rituxan, Actemra/RoActemra and Herceptin compensating for expected decline in Xeloda sales, while Diagnostics division sales were up 7%. Roche CEO Severin Schwan said: “Both the Pharma and Diagnostics Divisions posted solid growth in the first quarter. I am particularly pleased with the strong uptake of our recently launched medicines Perjeta and Kadcyla for HER2-positive breast cancer."
08:23 EDTRHHBYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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08:19 EDTRHHBYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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06:32 EDTRHHBYPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 10, 2014
11:42 EDTRHHBYReport claims Tamiflu, Relenza do little to prevent the spread of flu
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