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August 13, 2014
16:04 EDTAMGNAmgen says Phase 3 clinical trial FOCUS did not meet primary endpoint
Amgen and its subsidiary, Onyx Pharmaceuticals announced that the Phase 3 clinical trial FOCUS did not meet its primary endpoint of improving overall survival, OS. The 315-patient, open-label study evaluated single-agent Kyprolis® (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. Nearly all patients in the control arm received cyclophosphamide. Patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rate of cardiac events observed in the Kyprolis arm was consistent with the current U.S. Kyprolis label. There was an increase in the incidence of renal adverse events of all grades observed in the Kyprolis arm compared to the active control arm and the label. "While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world," said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals.
News For AMGN From The Last 14 Days
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October 1, 2014
07:39 EDTAMGNAmgen reinstated with a Neutral at BofA/Merrill
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September 30, 2014
07:30 EDTAMGNSachs 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
07:26 EDTAMGNInforma Business Information to hold a conference
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September 25, 2014
08:59 EDTAMGNSummer Street chief scientific officer holds an analyst/industry conference call
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08:11 EDTAMGNAmgen to host conference call
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September 22, 2014
09:02 EDTAMGNAmgen submits BLA to the FDA for immunotherapy blinatumomab
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September 17, 2014
08:03 EDTAMGNAmgen price target raised to $151 from $143 at Morgan Stanley
Morgan Stanley raised Amgen's price target to $151 based on increased brodalumab and AMG 416 expectations. Shares are Overweight rated.

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