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News Breaks
December 27, 2012
16:21 EDTABC, AMGNAmgen gets court approval in previously announced $762M settlement with FDA
U.S. District Judge Sterling Johnson, Jr. accepted a guilty plea by Amgen (AMGN) for illegally introducing a misbranded drug into interstate commerce, and approved Amgen’s global settlement with the United States in which Amgen agreed to pay $762M to resolve criminal and civil liability arising from its sale and promotion of certain drugs. Under the terms of the criminal plea agreement, Amgen will pay a criminal fine of $136M and criminal forfeiture in the amount of $14M. As part of the civil settlement, Amgen has agreed to pay $612M, of which $587.2M is to the United States and $24.8M to the states, to resolve claims that it caused false claims to be submitted to Medicare, Medicaid and other government insurance programs. In a separate civil settlement, International Nephrology Network, renamed Integrated Nephrology Network, a subsidiary of AmerisourceBergen Corporation (ABC), has also agreed to pay $15M to resolve civil liability arising from its role in the marketing of Aranesp. Reference Link
News For AMGN;ABC From The Last 14 Days
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May 29, 2015
09:16 EDTABCBofA/Merrill healthcare tech analyst holds analyst/industry conference call
Analyst Willoughby discusses relevant themes across the Healthcare Distribution & Technology subsectors on an Analyst/Industry conference call to be held on June 1 at 11 am.
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.
08:09 EDTABCAmerisourceBergen has a conference call hosted by JPMorgan
JPMorgan Analyst Gill will host a conference call with CEO Steve Collis on May 28 at 11 am.
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 18, 2015
10:01 EDTABCOn The Fly: Analyst Downgrade Summary
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07:42 EDTABCAmerisourceBergen downgraded to Market Perform from Outperform at Cowen
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07:22 EDTABCUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 18 at 8 am; not all company presentations may be webcasted. Webcast Link
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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