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News Breaks
February 5, 2014
06:18 EDTAMGN, MRKAmgen, Merck collaborate on combination treatment for advanced melanoma
Amgen (AMGN) and Merck (MRK), known as MSD outside the United States and Canada, announced that they have entered into an agreement through a subsidiary to evaluate the safety and efficacy of talimogene laherparepvec, an investigational oncolytic immunotherapy, combined with MK-3475, an investigational anti-PD-1 immunotherapy, in a Phase 1b/2 study of patients with mid- to late-stage melanoma. The multicenter, open-label clinical trial will be conducted in two parts and is planned to begin in the fall of 2014. Phase 1b is designed to determine the safety and tolerability of talimogene laherparepvec in combination with MK-3475 in patients with previously untreated, unresected, stage IIIB to IVM1a melanoma. The Phase 2 portion will evaluate efficacy, as assessed by the confirmed objective response rate, with talimogene laherparepvec in combination with MK-3475 versus MK-3475 alone in patients with previously untreated, unresected, stage IIIB to IVM1c melanoma. The study will also evaluate the efficacy of treatment with talimogene laherparepvec in combination with MK-3475 following disease progression on MK-3475 alone.
News For AMGN;MRK From The Last 14 Days
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September 17, 2014
08:03 EDTAMGNAmgen price target raised to $151 from $143 at Morgan Stanley
Morgan Stanley raised Amgen's price target to $151 based on increased brodalumab and AMG 416 expectations. Shares are Overweight rated.
September 16, 2014
07:31 EDTMRKEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:25 EDTMRKMerck price target raised to $72 from $62 at SunTrust
After meeting with Merck's CEO and head of clinical development, SunTrust increased its price target on the company as the firm thinks that it is ideally positioned across five of the fastest growing therapeutic classes. The firm believes that the company's EPS growth rates from 2015-2020 will be three percentage points above Street estimates, while it has a first-mover advantage in oncology. It keeps a Buy rating on the shares.
September 15, 2014
16:40 EDTAMGNAmgen trial finds Prolia treatment enables non-osteoporotic T-scores
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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."
13:30 EDTMRKMerck announces data from pivotal Phase 3 study for odanacatib
Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial, odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo.
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
16:00 EDTMRKOptions Update; September 10, 2014
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September 8, 2014
16:00 EDTMRKOptions Update; September 8, 2014
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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 5, 2014
16:45 EDTMRKMarket ends week little changed after mixed economic data
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11:17 EDTMRKBristol-Myers files patent infringement suit against Merck
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08:39 EDTMRKMerck Keytruda sales to reach $5B in 2018, says BMO Capital
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September 4, 2014
15:16 EDTMRKMerck receives accelerated approval of Keytruda
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09:02 EDTMRKMerck's relebactam granted QIDP, fast track designations by FDA
Merck announced that the U.S. Food and Drug Administration has designated relebactam -- previously known as MK-7655 -- the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product with designated Fast Track status. The QIDP and Fast Track designations apply to intravenous use of relebactam for the treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Relebactam is an investigational, class A and C, beta-lactamase inhibitor that is being evaluated in combination with imipenem/cilastatin in ongoing Phase 2 clinical trials for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. In preclinical studies, relebactam administered in combination with imipenem/cilastatin demonstrated antibacterial activity against a broad range of Gram-negative and beta-lactam-resistant pathogens. Merck plans to initiate Phase 3 studies with relebactam in combination with imipenem/cilastatin in 2015.
07:21 EDTMRKMedidata can obtain major new platform customers, says Stifel
Noting that Medidata (MDSO) partners with Veeva, Stifel believes that a number of Veeva (VEEV) customers could become Medidata platform customers, especially if they already use Medidata for R&D and clinical trial solutions. The firm identifies Merck (MRK), Gilead (GILD), and Teva (TEVA) as companies that may become platform clients for Medidata. Stifel keeps a $55 price target and Buy rating on Medidata.
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