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July 15, 2013
19:14 EDTAMGNInterim results from Amgen Phase 2 study published
Amgen announced the Lancet Oncology published planned interim results from an international, open-label, Phase 2 clinical trial that is evaluating Xgeva in adults and skeletally mature adolescents diagnosed with giant cell tumor of bone. The study's primary endpoint is the safety profile of Xgeva. Secondary endpoints are the time to disease progression and the proportion of patients without any surgery at six months. Based on the investigators' interim assessment, 96% of patients with surgically unsalvageable GCTB had no disease progression after a median follow-up of 13 months. In those with salvageable GCTB whose surgery was associated with severe morbidity, 74% of patients required no surgery, and 62% of patients who had surgery underwent a less morbid procedure than planned. Overall, 72% of patients had objective tumor response, per protocol defined criteria, including 25% of patients who had an objective tumor response according to modified response evaluation criteria in solid tumors. The overall safety profile was found to be consistent with the known safety profile of Xgeva in patients with advanced cancer. Osteonecrosis of the jaw was reported in 1% of patients. Hypocalcemia adverse events, all non-serious, were reported in 5% of patients. The most common severe adverse events were low phosphate levels, back pain, pain in extremity, depression, musculoskeletal pain and anemia. Serious adverse events were reported in 9% of patients. No treatment-related deaths were reported.
News For AMGN From The Last 14 Days
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February 10, 2016
07:15 EDTAMGNLeerink to hold a conference
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February 8, 2016
15:59 EDTAMGNU.K. cost regulator reverses stance on Amgen's Repatha, PharmaTimes says
The U.K.'s National Institute for Health and Care Excellence has reversed its prior decision barring patients from accessing Amgen's cholesterol treatment Repatha, reports PharmaTimes. The agency will now allow use of the drug, alone or in combination with other therapies, for various classes of patients, though only at a 140mg biweekly dose and only as long as the company continues to offer certain discounts, the report noted. Reference Link
February 5, 2016
09:26 EDTAMGNLeerink biotech analyst holds an analyst/industry conference call
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06:03 EDTAMGNAmgen resumed with a Market Perform at Leerink
Leerink analyst Geoffrey Porges resumed coverage of Amgen with a Market Perform rating and $179 price target.
February 4, 2016
19:15 EDTAMGNAmgen reinitiated with a Market Perform at Leerink
Target $179.
16:28 EDTAMGNAmgen reports BLINCYTO study met primary endpoint, stopped early for efficacy
Amgen announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase 3 TOWER study. The randomized, open-label TOWER study evaluated the efficacy of BLINCYTO versus standard of care in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The independent data monitoring committee recommended, and Amgen has accepted, that the study end early for efficacy. The BLINCYTO adverse events observed in the TOWER study were consistent with the known safety profile of BLINCYTO. Secondary endpoints are currently being evaluated.
16:02 EDTAMGNAmgen says trial of Repatha meets co-primary endpoints
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February 3, 2016
08:57 EDTAMGNPullback in biotech makes M&A more attractive, says UBS
UBS analyst Andrew Peters noted the pullback in small and mid-cap biotechs and said a consequence of the lower valuations may be an increased appetite for M&A by the larger firms. Peters noted Gilead (GILD) commented on its earnings call that "there's no question" the pullback has made M&A more attractive. UBS said with valuations so far off their highs, the question remains whether management and boards will accept deals at such depressed levels.
08:48 EDTAMGNWorkday appoints Diana McKenzie as Chief Information Officer
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February 2, 2016
08:53 EDTAMGNPiper Jaffray biopharma analyst holds an analyst/industry conference call
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February 1, 2016
08:25 EDTAMGNAlder pullback Friday a buying opportunity, says Leerink
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January 29, 2016
13:38 EDTAMGNAmgen wins right to allege willful infringement in Praluent suit, Markman says
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