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News Breaks
June 2, 2014
07:48 EDTAMGNAmgen presents new data that support potential of talimogene laherparepvec
Amgen announced new data from two key clinical trials that support the potential of talimogene laherparepvec, a novel, investigational oncolytic immunotherapy, as both a single agent and as part of a combination regimen in patients with metastatic melanoma. Data from the 19 patients in the Phase 1b combination study showed no dose-limiting toxicities with talimogene laherparepvec in combination with ipilimumab. Additionally, tumors either shrank in size or were no longer detectable in 56 percent of patients when talimogene laherparepvec was given prior to and in combination with ipilimumab. The most common adverse events observed were chills, fevers, rash and fatigue. The pivotal Phase 3 trial met its primary endpoint showing a statistically significant improvement in durable response rate. Detailed results of the overall survival analysis, a key secondary endpoint of the pivotal Phase 3 trial evaluating talimogene laherparepvec as a single agent, were also presented. The results demonstrated a 4.4 month improvement in overall survival which closely approached statistical significance in the total patient population tested that included patients with and without visceral tumors.The most frequent adverse events observed in this trial were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia.
News For AMGN From The Last 14 Days
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August 28, 2015
13:53 EDTAMGNAnthem has not made coverage decision about Amgen's Repatha, Bloomberg reports
Bloomberg cites an emailed statement from Anthem (ANTM) regarding Amgen's (AMGN) Repatha injection, which was approved last night by the FDA as an option for some patients who are unable to get their low-density lipoprotein cholesterol under control with current treatment options.
08:01 EDTAMGNAmgen pricing for Repatha competitive with Praluent, says Piper Jaffray
After the FDA announced last night that it has approved Amgen's (AMGN) Repatha injection, Piper Jaffray analyst Joshua Schimmer said that the drug's indications seem "generally in line" with those for Praluent from Regeneron (REGN) and Sanofi (SNY). Amgen disclosed an annual WAC of $14,100 for Repatha, which the analyst notes is about $500 per year below Praluent, but Schimmer said that the actual recognized price for each will ultimately be determined by discounting. Schimmer also noted that Amgen said it is working with payers and other purchasers on "innovative pricing programs," though he is uncertain if that means the company is working on a kind of "pay per performance" scheme. The analyst, who believes the market will prove large enough for both treatments, keeps a $200 price target and Overweight rating on Amgen shares.
August 27, 2015
19:14 EDTAMGNExpress Scripts to cover both Repatha, Praluent for now, Bloomberg says
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18:52 EDTAMGNOn The Fly: After Hours Movers
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17:58 EDTAMGNEsperion up 1.9% after FDA approves Amgen cholesterol drug Repatha
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17:55 EDTAMGNAmgen confirms FDA approval of Repatha cholesterol-lowering medication
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17:24 EDTAMGNFDA approves Repatha
The U.S. Food and Drug Administration approved Repatha injection for some patients who are unable to get their low-density lipoprotein cholesterol under control with current treatment options. Repatha is marketed by Amgen Inc., of Thousand Oaks, Calif. Reference Link
08:06 EDTAMGNFDA PDUFA Date for Amgen's Repatha is August 27, 2015
August 26, 2015
06:02 EDTAMGNAmgen implied volatility of 41 at upper end of index
August 25, 2015
09:16 EDTAMGNAmgen to present Repatha data analysis at ESC Congress 2015
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09:02 EDTAMGNAmgen submits NDA for hyperparathyroidism treatment
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August 24, 2015
13:36 EDTAMGNBiotech correction presents some opportunities, says RBC Capital
RBC Capital analyst Michael Yee said he won't try to pick the short-term bottom in biotech, but contends that any macro weakness in China shouldn't have any major impact to financials or fundamentals for the sector given their minimal exposure there. If the market continues to be volatile, Yee recommends a focus on names with defensive characteristics, such as higher margins and free cash flow yield, naming Amgen (AMGN), Celgene (CELG) and Gilead (GILD) as some examples. The analyst adds that he likes Vertex (VRTX) on the pullback for "more aggressive" growth investors. Yee has Outperform ratings on all of the stocks mentioned above.
August 18, 2015
12:06 EDTAMGNAmgen to pay $71M in 48-state settlement over Aranesp, Enbrel promotions
West Virginia Attorney General Patrick Morrisey announced his Office has participated in a $71M multi-state settlement with Amgen to resolve allegations it unlawfully promoted the biologic medications Aranesp and Enbrel. West Virginia will receive $845,637.82 as part of the settlement, which was negotiated between the company and Attorneys General from 48 states and the District of Columbia. A complaint in the matter was filed Tuesday morning in Kanawha County Circuit Court. Aranesp is used to treat certain types of anemia by stimulating bone marrow to produce red blood cells. Enbrel is used to treat a number of conditions, including plaque psoriasis. In addition to the $71M settlement, the agreement requires Amgen to reform its marketing and promotional practices. In addition to West Virginia, the other states participating in this settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin and Wyoming and the District of Columbia.
09:19 EDTAMGNPiper Jaffray biopharma analyst holds an analyst/industry conference call
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09:07 EDTAMGNAmgen and University of California announce education program partnership
Amgen and the Center for Social Sector Leadership at the University of California, or UC, Berkeley's Haas School of Business announced a multi-year partnership to offer a graduate-level course on measuring outcomes of cancer patient advocacy education and support programs. The MBA course, Social Impact Metrics, is designed to advance the ability of nonprofit organizations to measure the effectiveness of their programs, which is critical in an increasingly challenging donor environment. The overall goal of the initiative is to create a set of measurement best practices that can be adopted across the cancer nonprofit community and beyond.
August 17, 2015
08:23 EDTAMGNDeutsche Bank biotech analyst holds an analyst/industry conference call
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