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News Breaks
December 4, 2012
07:55 EDTAMGN, AMGN, GSK, GSK, THLD, THLDThe FDA Oncologic Drugs Advisory Committee to hold a meeting
The Pediatric Oncology Subcommittee considers and discusses issues relating to development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products are: (1) GlaxoSmithKline's Trametinib; (2) Threshold Pharmaceuticals' TH-302; (3) Boehringer Ingelheim Pharmaceuticals' volasertib (BI 6727) and (4) Amgen's blinatumomab (MT 103 in a meeting being held at FDA Silver Springs offices on December 4 at 8 am. Webcast Link
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September 16, 2014
07:31 EDTGSKEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
September 15, 2014
16:40 EDTAMGNAmgen trial finds Prolia treatment enables non-osteoporotic T-scores
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16:10 EDTGSKFive Prime announces option exercise by GlaxoSmithKline to obtain license
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16:05 EDTAMGNAmgen says romosozumab treatment increases bone mineral density
Amgen and UCB announced results from several exploratory analyses of the Phase 2 study evaluating romosozumab in postmenopausal women with low bone mineral density, BMD. Romosozumab is an investigational bone-forming agent that is designed to work by inhibiting the protein sclerostin, thereby increasing bone formation and decreasing bone breakdown. These data were presented at the American Society for Bone and Mineral Research, ASBMR, 2014 Annual Meeting in Houston, Sept. 12-15. "Fractures or broken bones due to osteoporosis are very common and often have a life altering impact on an older woman and her family," said Michael McClung, M.D., director of the Oregon Osteoporosis Center. "It is encouraging to see that treatment with romosozumab for a second year provided additional increases in bone mineral density beyond what was seen during the first 12 months of treatment." "Despite continuing progress in the management and treatment of patients with osteoporosis, there remains a considerable need for new therapeutic approaches for individual patients," said Professor Dr. Iris Loew-Friedrich, chief medical officer and executive vice president, UCB. "Investigational studies to date suggest that the bone building capacity of romosozumab may show promise as a new treatment option to manage this serious disease. We look forward to reporting the results of the romosozumab Phase 3 program in 2016."
07:27 EDTGSKIBC Life Sciences to hold a conference
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07:21 EDTAMGNHeart Failure Society of America to hold annual meeting
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05:12 EDTAMGNAmgen presents analyses of Phase 3 ivabradine data for treatment of chronic HF
Amgen announced data from the Phase 3 Systolic Heart failure treatment with the If inhibitor ivabradine Trial, or SHIFT, study evaluating ivabradine in patients with chronic heart failure, or HF, were presented at the 18th Annual Scientific Meeting of the Heart Failure Society of America, or HFSA, in Las Vegas. A post-hoc analysis from the SHIFT study confirmed low systolic blood pressure, or SBP, is associated with poor outcomes in chronic HF, and that ivabradine reduced the primary composite endpoint of cardiovascular death or hospitalization for worsening HF in this subgroup with low baseline SBP. Safety was similar across the three SBP groups. Results were published in the July 2014 issue of the European Journal of Heart Failure. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen said, "Despite standard of care, chronic heart failure remains a disabling condition with a poor prognosis for patients at risk for hospitalization. Analyses from the pivotal SHIFT study complement the main trial findings that form the basis of our U.S. submission package for ivabradine. We recently received a priority review designation for ivabradine from the FDA and are working with the agency to potentially bring this important treatment option to certain patients with chronic heart failure in the U.S. as soon as possible."
September 14, 2014
13:39 EDTAMGNFurther gains in Amgen could be subdued, Barron's says
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September 12, 2014
07:14 EDTAMGNAmerican Society for Bone & Mineral Research holds annual meeting
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September 10, 2014
09:58 EDTGSKGlaxoSmithKline has a conference call hosted by JPMorgan
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September 9, 2014
11:17 EDTTHLDHigh option volume stocks
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09:12 EDTTHLDOn The Fly: Pre-market Movers
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06:25 EDTGSKDocuments show DOJ probed GSK China unit in 2012, Reuters says
Internal documents revealed that a U.S. anti-bribery investigation into GlaxoSmithKline (GSK) touched on the firm's Chinese consumer healthcare division two years ago, which infers that the company's compliance issues in the country could be broader than initially discovered, according to Reuters, citing the documents. Reference Link
September 8, 2014
18:31 EDTTHLDOn The Fly: After Hours Movers
UP AFTER EARNINGS: Casey's General Stores (CASY), up 3.6%... Korn/Ferry (KFY), up 2.8%. ALSO HIGHER: Annies (BNNY), up 37.3% after General Mills (GIS) announced it will acquire the company for $46 per share... General Mills is trading just under 1% higher... Following the Annies/General Mills announcement, Hain Celestial Group (HAIN) is 3.6% higher, WhiteWave Foods (WWAV) is up 6.3%, and Boulder Brands (BDBD) is up 8.7%... iPass (IPAS), up 35.1% after announcing that it is exploring strategic alternatives... CTI BioPharma (CTIC), up 8.1% after being initiated with an Overweight at Piper Jaffray... Threshold Pharmaceuticals (THLD), up 5% after being initiated with a Buy at Cantor. DOWN AFTER EARNINGS: Pep Boys (PBY), down 6.7% following second quarter miss. ALSO LOWER: Pinnacle Foods (PF), down 3.7% after filing an automatic common stock shelf and announcing the sale of 15M shares of common stock for holders... Physicians Realty Trust (DOC), down 4.9% after offering 9M common shares.
16:11 EDTTHLDThreshold Pharmaceuticals initiated with a Buy at Cantor
Target $14.
15:58 EDTTHLDThreshold Pharmaceuticals calls active
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08:48 EDTGSKGilead announces AMBITION study results in collaboration with Glaxo
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07:15 EDTAMGNIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
06:49 EDTAMGNAmgen shares to trend higher, price target to $150 at RBC Capital
RBC expects shares of Amgen to trend higher due to evolving sentiment around the 2015 pipeline and low multiple. Some investors want a break-up of the company to increase shareholder value but the analyst does not expect it to occur given the concentrated portfolio, tax reasons, and a commercial infrastructure that can not be split off. Shares are Outperform rated with a $150 price target, raised from $135.
September 7, 2014
13:57 EDTGSKGlaxoSmithKline Ebola vaccine works in tests on monkeys, Bloomberg says
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