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Stock Market & Financial Investment News

News For AMGN;THLD;GSK From The Last 14 Days
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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
07:19 EDTTHLDThreshold Pharmaceuticals initiates Phase 2 trial of tarloxotinib bromide
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August 26, 2015
17:06 EDTGSKGilead AMBITION study results published in New England Journal of Medicine
Gilead Sciences (GILD) announced detailed results from the AMBITION study. In AMBITION, conducted in collaboration with GlaxoSmithKline (GSK), combination therapy with Letairis and tadalafil reduced the risk of clinical failure by 50% compared to the pooled Letairis and tadalafil monotherapy arm. These data were published in The New England Journal of Medicine. Letairis, a selective endothelin type-A receptor antagonist, and tadalafil, a PDE5 inhibitor, are each approved in the United States, the European Union and other countries as once-daily treatments for patients with pulmonary arterial hypertension with WHO/NYHA functional class II and III symptoms. Letairis is indicated in the U.S. to improve exercise ability and delay clinical worsening and in the EU under the tradename Volibris to improve exercise capacity. Tadalafil 40 mg is indicated in the U.S. and the EU to improve exercise ability and capacity, respectively. Preclinical data have suggested these therapies may have synergistic effects. However, combination use with Letairis and tadalafil is currently not approved.
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.
13:15 EDTGSKFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
August 21, 2015
05:25 EDTGSKNovartis acquires all remaining rights to Ofatumumab from GSK
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.
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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August 14, 2015
16:44 EDTAMGNThird Point gives quarterly update on stakes
NEW STAKES: Baxter (BAX), T-Mobile (TMUS), Sealed Air (SEE), Devon (DVN), and Perrigo (PRGO). INCREASED STAKES: SunEdison (SUNE), Dow Chemical (DOW), Mohawk (MHK), Yum! Brands (YUM), and IAC/InterActiveCorp (IACI). DECREASED STAKES: Ally Financial (ALLY), Amgen (AMGN), Sensata (ST), Masco (MAS), and Delta (DAL). LIQUIDATED STAKES: Dollar General (DG), McKesson (MCK), Edgewell Personal Care (EPC), Maxim (MXIM), and FleetCor (FLT).
06:19 EDTGSKGlaxoSmithKline says NC plant meds safe from Legionnaires' bacteria, AP reports
GlaxoSmithKline said that the medications manufactured at its pharmaceutical plant in Zebulon, North Carolina are safe despite the company's decision to shut down the factory after the discovery of Legionnaires' bacteria, the Associated Press reports, citing an email from company spokeswoman Jenni Brewer Ligday. North Carolina health officials have said that no cases of Legionnaires' disease linked to the Glaxo plant have been reported, the report says. Reference Link
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