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News Breaks
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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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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