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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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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
March 17, 2015
16:11 EDTAMGNAmgen to present 10 abstracts from dermatology portfolio
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March 16, 2015
08:52 EDTAMGNAmgen to hold a conference call
Conference call to provide an update from the 73rd Annual Meeting of AAD will be held on March 23 at 3 pm. Webcast Link
08:35 EDTAMGNAmgen to hold a conference call
Executive Vice President of R&D, Sean Harper, discusses Amgen's cardiovascular program, including the Repatha data currently being presented at the American College of Cardiology's Scientific Session & Expo, on a conference call to be held on March 16 at 4 pm. Webcast Link
08:23 EDTAMGNPCSK9 data continues to impress, says Leerink
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06:57 EDTAMGNAmgen clinical data very positive, says RBC Capital
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06:40 EDTAMGNPCSK9 studies show potential improvement in heart health, WSJ says
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