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News Breaks
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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May 22, 2015
16:24 EDTAMGNAmgen to end participation in co-development and commercialization of brodalumab
Amgen (AMGN) announced the company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca (AZN). Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. The decision was based on events of suicidal ideation and behavior in the brodalumab program, which Amgen believes likely would necessitate restrictive labeling. After Amgen transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab. Amgen has decided to focus its efforts and resources on other key molecules that address unmet medical needs and deliver value to patients and shareholders. The Company continues to make progress against its strategic and financial commitments and does not expect any meaningful impact from this decision on its ability to meet them.
07:32 EDTAMGNAmgen receives positive CHMP opinion for use of Repatha
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the marketing authorization of Repatha recommending approval for use in certain patients with high cholesterol. Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood. The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
May 21, 2015
14:48 EDTAMGNRegeneron primary driver remains Praluent, says Piper Jaffray
Piper Jaffray noted that Regeneron (REGN) shares are at all-time highs after the company and partner Sanofi reported Phase IIb data on Dupilumab and Phase III data on Sarilumab. However, the firm believes the primary driver for Regeneron remains Praluent and firm expects launch costs to outstrip sales growth. Piper acknowledges Regeneron has "one of the richest pipelines in all of biotech," but it sees risk around Amgen's (AMGN) patent suit and keeps its Neutral rating and $484 price target on the stock.
May 20, 2015
09:52 EDTAMGNAlliance for Health Reform holds a webcast on biosimilars
"Biosimilars in the U.S.: Current & Emerging Issues" provides essential background on the U.S. and international markets for reference biologics and biosimilars, outline current policy and regulatory issues, and describe implications for the future. Speakers include Chief Scientific Officer Ramachandra from Hospira, Executive Director Eich from Amgen on the briefing being held on May 20 at 12 pm. Webcast Link
May 19, 2015
08:57 EDTAMGNLeerink biotech analyst holds an analyst/industry conference call
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07:51 EDTAMGNFDA PDUFA Date for Amgen's Blinatumomab is May 19, 2015
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May 15, 2015
12:13 EDTAMGNThird Point gives quarterly update on stakes
NEW STAKES: Yum! Brands (YUM), NXP Semiconductors (NXPI), FedEx (FDX), McKesson (MCK), and J M Smucker (SJM). INCREASED STAKES: Actavis (ACT), Roper Technologies (ROP), Delta Air Lines (DAL), and FleetCor Technologies (FLT). DECREASED STAKES: Ally Financial (ALLY), Amgen (AMGN), Phillips 66 (PSX), eBay (EBAY), and Anheuser Busch Inbev SA (BUD). LIQUIDATED STAKES: Alibaba Group (BABA), Citigroup (C), EMC Corporation (EMC), Anglo American (AAL), and Williams Companies (WMB).
05:32 EDTAMGNAmgen presents first Phase 2 data for AMG 334
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May 14, 2015
10:41 EDTAMGNAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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07:44 EDTAMGNInternational Headache Society to hold a conference
17th Congress of the International Headache Society is being held in Valencia, Spain on May 14-17.
May 13, 2015
17:17 EDTAMGNAmgen to present key results in solid tumor, hematologic malignancy treatments
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