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News Breaks
February 22, 2013
17:48 EDTAMGNAmgen issues statement on CBO analysis of oral-only treatments for patients
Amgen notes that an analysis by the Congressional Budget Office released this week shows that, contrary to the implications of past media reports, keeping oral-only drugs in Medicare Part D would actually achieve significant savings over time for both taxpayers and the Medicare program. As noted by the Government Accountability Office, it is important that the Centers for Medicare and Medicaid Services take the time needed to develop quality metrics and further develop their data systems, both of which are essential to providing quality care for an elderly and chronically ill patient population. Amgen will continue to advocate for sound federal policies that enhance access to care for these patients.
News For AMGN From The Last 14 Days
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May 29, 2015
13:52 EDTAMGNAmgen to hold an analyst event
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08:32 EDTAMGNAmgen and Merck expand collaboration to study talimogene laherparepvec
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07:06 EDTAMGNAmerican Society of Clinical Oncology to hold annual meeting
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06:49 EDTAMGNAmgen presents pooled Phase 3 AMG 416 data
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May 28, 2015
16:06 EDTAMGNAmgen launches program to further advance basic biology research
Amgen announced the creation of a catalog of qualified tools and reagents available to academic institutions to help further research and advance basic discoveries in biology, as well as deepen relationships with academic institutions. This catalog and its associated materials are called the Amgen Biology-Enabling Resource, or AmBER. AmBER is comprised of more than 1,000 elements and includes small molecules, peptides, antibodies and recombinant proteins, engineered cell lines, and genetically-engineered mice. These are tools created to support discovery activities throughout Amgen's history and have been extensively validated in most cases.
08:21 EDTAMGNAmgen could be hurt by Roche deal, says RBC Capital
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May 26, 2015
16:18 EDTAMGNAmgen announces publication of previous OPTiM data, says met primary endpoint
Amgen announced the publication of primary results from the phase 3 OPTiM study in the Journal of Clinical Oncology. The data published in JCO, which were previously presented at the annual meetings of the American Society of Clinical Oncology in 2013 and 2014, demonstrated a significantly higher durable response rate in patients with unresected stage IIIB, IIIC or IV metastatic melanoma receiving the investigational oncolytic immunotherapy talimogene laherparepvec compared to those who received granulocyte-macrophage colony-stimulating factor. Results showed that the primary endpoint of DRR was met, however the secondary endpoint of overall survival was not met, although there was a strong trend in favor of talimogene laherparepvec. A DRR measures the number of patients who had a complete response or partial response within the first 12 months of treatment and maintained the response continuously for at least 6 months. The most frequent adverse events observed in this study were chills, pyrexia, injection-site pain, nausea, flu-like symptoms and fatigue. The most common serious AEs included disease progression, cellulitis and pyrexia. No treatment-related deaths were observed. The OPTiM data serve as the basis of a BLA which has been accepted for review by the U.S. FDA and a Marketing Authorization Application in the EU for talimogene laherparepvec for the treatment of adults with regionally or distantly metastatic melanoma. The FDA has set a review goal date of October 27.
09:23 EDTAMGNOn The Fly: Pre-market Movers
UP AFTER EARNINGS: AutoZone (AZO), up marginally after reporting third quarter results. ALSO HIGHER: Geeknet (GKNT), up 119.7% after being acquired by Hot Topic for $17.50 per share... IntelliPharmaCeutics (IPCI), up 16.8% after being granted fast track designation for Rexista Oxycodone by FDA... McDermott (MDR), up 9.2% after favorable mention in Barron's and after being awarded a project for 12 jackets offshore Saudi Arabia... Time Warner Cable (TWC), up 5.2% following announcement of merger with Charter (CHTR)... Charter is up fractionally. DOWN AFTER EARNINGS: Sky-mobi (MOBI), down 7.9%. ALSO LOWER: Etsy (ETSY), down 5.7% following a Wall Street Journal report that Amazon.com (AMZN) is targeting Etsy with an artisan goods marketplace... First Solar (FSLR), down 4.1% after being downgraded to Underperform from Sector Perform at RBC Capital... AstraZeneca (AZN), down 1.9% after Amgen (AMGN) ends participation in co-development and commercialization of brodalumab... Amgen is down 1.5%.
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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