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News Breaks
April 3, 2014
09:37 EDTAMGN, GSKAmgen to pay GlaxoSmithKline $275M to terminate denosumab collaboration pact
Amgen (AMGN) disclosed in a regulatory filing that the company and Glaxo Group (GSK) entered into an agreement terminating in part and amending in part the collaboration agreement dated as of July 27, 2009 relating to the commercialization of denosumab for osteoporosis indications in certain geographic territories. The transition agreement terminates the prior collaboration agreement for all countries and regions of the collaboration territory, including the European Union, Switzerland, Norway, Russia and Mexico, except for Australia. All commercial activities assigned to GSK under the collaboration agreement other than those in Australia will be transitioned back to Amgen no later than December 31. In exchange for the early termination, except Australia, Amgen will pay to GSK an initial payment and specific milestones over the transition period totaling $275M. In addition, Amgen will reimburse GSK $15M for costs incurred by GSK in performing its obligations. The transition agreement does not change the terms of the separate expansion agreement dated as of July 27, 2009 relating to the commercialization of denosumab for all indications in certain geographic territories, Amgen said.
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August 28, 2014
07:34 EDTGSKGSK could start testing Ebola vaccine on humans next week, Bloomberg reports
GlaxoSmithKline could begin tests of its experimental vaccine for Ebola on humans as early as next week in the U.S., Bloomberg reports. GSK is developing the vaccine with the Vaccine Research Center of the National Institutes of Health, and they have received FDA approval to begin the Phase 1 trial, Michael Kurilla, director of the Office of Biodefense, Research Resources and Translational Research, says. Reference Link
August 27, 2014
17:49 EDTGSKGSK, Shire rumored to be interested in Tekmira, Daily Mail says
GlaxoSmithKline (GSK) and Shire (SHPG) are rumored to be interested in a bid for Tekmira (TKMR), reports Daily Mail. Tekmira could be a value to potential suitors, capitalized at approximately GBP 400M and the company could cost over GBP 1B in a takeover, Daily Mail adds. Reference Link
09:20 EDTAMGNFDA grants Amgen priority review designation for ivabradine
Amgen announced the U.S. Food and Drug Administration has granted priority review designation for ivabradine for the treatment of chronic heart failure. Ivabradine is an oral drug that inhibits the If current in the sinoatrial node, the body's cardiac pacemaker. The New Drug Application is based on global clinical trial data from the Phase 3 SHIFT, or Systolic Heart failure treatment with the If inhibitor ivabradine Trial), study. The SHIFT study compared ivabradine to placebo on top of standard-of-care therapies, including beta-blockers, in more than 6,500 patients in sinus rhythm with reduced left ventricular function and heart rate greater than 70 beats per minute.
08:03 EDTGSKGlaxoSmithKline receives FDA approval for sNDA for Promacta/Revolade
Ligand Pharmaceuticals Incorporated (LGND) announced that its partner GlaxoSmithKline (GSK) has received approval of a supplemental New Drug Application for the once-daily use of Promacta/Revolade in patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells and platelets.2 Eltrombopag, an oral thrombopoietin receptor agonist, works by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells.
August 26, 2014
14:42 EDTGSKGlaxoSmithKline receives FDA approval of additional Promacta indication
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11:21 EDTAMGNAmgen added to short term buy list at Deutsche Bank
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08:47 EDTGSKGenetic Technologies says NC court denies GlaxoSmithKline motion to dismiss
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August 25, 2014
16:17 EDTAMGNWestern Digital CFO Leyden to retire, Olivier Leonetti to succeed
Western Digital (WDC) announced that CFO Tim Leyden is retiring. He is being succeeded by Olivier Leonetti, who has served as vice president, finance at Amgen (AMGN) from 2011. Leyden will remain with the company through January 2015 in a transition role and advisory capacity to president and chief executive officer Steve Milligan and to Leonetti for an interim period to ensure a smooth transition. The changes are effective as of September 8.
12:19 EDTGSKOn The Fly: Midday Wrap
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10:40 EDTGSKBiotechs rise after InterMune acquired by Roche
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August 22, 2014
14:19 EDTGSKViiV Healthcare receives FDA approval for HIV-1 treatment Triumeq
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August 20, 2014
15:35 EDTGSKGlaxoSmithKline receives FDA approval for Arnuity Ellipta in the U.S.
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11:44 EDTGSKMylan completes second bidding round for GSK prescription portfolio, WSJ says
Mylan (MYL), TPG Capital, Advent International, KKR (KKR), Warburg Pincus and a few Indian prescription manufacturers have completed the second round of bidding for GlaxoSmith Kline's (GSK) portfolio of mature medications, according to The Wall Street Journal, citing people familiar with the sales process. GSK noted that it aims to sell a portfolio of drug brands in the U.S. and EU with yearly sales of approximately $1.66B. Reference Link
08:30 EDTGSKPernix closes acquisition of Treximet
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08:29 EDTGSKPernix Therapeutics to host conference call
Conference call to discuss acquisition of Treximet will be held on August 20 at 9 am. Webcast Link
08:04 EDTGSKPOZEN announces U.S. rights for Treximet acquired by Pernix Therapeutics
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August 19, 2014
05:11 EDTAMGNGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
17:25 EDTAMGNAmgen announces AMG 416 study met its primary and all secondary endpoints
Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism, SHPT, in patients with chronic kidney disease,CKD, receiving hemodialysis, met its primary and all secondary endpoints. "The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
August 15, 2014
06:54 EDTAMGNAmgen shares should 'grind higher' this year, says RBC Capital
RBC Capital expects Amgen shares to "grind higher" this year driven by a greater appreciation of pipeline programs, the Analyst Day on October 28, an expected filing of the PCSK-9 program soon, and positive Ph iiB anti-CGRP migraine data expected year-end. Shares are Outperform rated.
06:34 EDTGSKLawyer says GSK connected investigators to not appeal ruling, Reuters says
Defense lawyer Zhai Jian said GlaxoSmithKline connected corporate investigator Peter Humphrey and his American wife are not aiming to appeal a Chinese court's prison sentence ruling, according to Reuters, citing comments from Jian. Reference Link
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