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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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March 30, 2015
09:02 EDTAMGNAmgen says FDA grants priority review for Kyprolis sNDA
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March 26, 2015
06:45 EDTAMGNBiotech valuation concerns 'misguided,' says Piper Jaffray
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March 24, 2015
09:10 EDTAMGNDako announces collaboration agreement with Amgen
Dako, an Agilent Technologies (A) company, announced a new Master Collaboration Agreement with Amgen (AMGN). The expanded collaboration will allow both companies to benefit from knowledge-sharing within the field of drug-diagnostic research and development in general, and in relation to companion diagnostic products in particular. The financial details of the agreement were not disclosed.
March 23, 2015
12:10 EDTAMGNTeva migraine drug data positive for Amgen, says Piper Jaffray
Piper Jaffray said the "positive" trial data Teva (TEVA) reported for its anti-CGRP antibody in migraines is another important validation for the class of drugs that is also being worked on by Amgen (AMGN), Eli Lilly (LLY) and Alder Biopharmaceuticals (ALDR). The firm said it thinks Amgen is one of the leaders in CGRP antibody space and reiterated its Overweight rating and $187 price target on Amgen shares.
09:03 EDTAMGNLeerink analysts hold a meeting with a conference call hookup
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March 20, 2015
09:06 EDTAMGNAmgen submits application for marketing approval for RepathaTM in Japan
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07:41 EDTAMGNAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
15:55 EDTAMGNAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTAMGNAmgen denied preliminary injunction for biologics against Novartis, Reuters says

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