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News Breaks
February 27, 2014
06:11 EDTNVO, MRK, BMYFDA eases worries regarding certain diabetes medications, AP says
The federal Food and Drug Administration and its European counterpart started reviews last year of diabetes drugs which include Merck's (MRK) Januvia and Janumet, Novo Nordisk's (NVO) Victoza and Bristol-Myers Squibb's (BMY) Byetta and Bydureon, reported the Associated Press. Both U.S. and European regulators have found no evidence of a link between these drugs and pancreas problems or pancreatic cancer. Reference Link
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April 17, 2015
09:36 EDTBMYActive equity options trading on open
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09:08 EDTBMYBristol-Myers data should be positive, says SunTrust
SunTrust expects the AACR data for Bristol-Myers' CheckMate-069 Opdivo + Yervoy combo, a treatment for melanoma, to show a positive overall response rate and progressive free survival that exceeds its prior -0004 results. The firm notes that the data is due to be presented on April 20. It raised its 2020 Opdivo revenue estimate to $7.1B versus the Street's $6.9B and raised its price target o n he stock to $74 from $70 while keeping a Buy rating on the shares.
08:58 EDTBMYBristol-Myers jumps 4% after Opdivo study stopped early after meeting endpoint
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08:56 EDTBMYBristol-Myers says Phase III Opdivo study met endpoint, trial stopped early
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April 16, 2015
12:16 EDTBMYEli Lilly and Bristol-Myers restructure Erbitux collaboration in N. America
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08:59 EDTBMYGene therapy companies could benefit from increased attention, says Roth Capital
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April 15, 2015
11:55 EDTNVONovo Nordisk initiated with a Sell at Societe Generale
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09:08 EDTBMYOn The Fly: Pre-market Movers
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08:33 EDTMRKFDA panel results positive for Merck, says SunTrust
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07:41 EDTNVO, BMYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
07:03 EDTBMYLexicon and Bristol-Myers select development candidate for neuropathic pain
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April 14, 2015
13:32 EDTMRKMerck, NewLink Genetics confirm initiation of Phase 3 trial of Ebola vaccine
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April 13, 2015
08:58 EDTMRKMerck may have positive read through from briefing docs, says SunTrust
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April 9, 2015
09:25 EDTMRKPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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April 8, 2015
08:08 EDTBMYuniQure price target raised to $50 from $28 at Leerink
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08:06 EDTBMYBristol-Myers completes acquisition of Flexus Biosciences
Bristol-Myers Squibb Company announced that it has completed the previously announced planned acquisition of Flexus Biosciences, Inc. The transaction includes full rights to F001287, Flexus’ lead preclinical, small-molecule IDO1-inhibitor targeted for IND filing in the second half of 2015 and an IDO/TDO discovery program that includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries. A newly formed entity established by the current shareholders of Flexus will retain, from and after the closing, all non-IDO/TDO assets of Flexus including those related to Flexus’ Phase 1 FLT3 and CDK4/6 inhibitor, its earlier stage small-molecule Treg cancer immunotherapy programs, and its current personnel and facilities.
07:33 EDTMRKAdvaxis, Merck begin enrollment in Phase 1/2 of ADJX-PSA with Keytruda
Advaxis (ADXS) and Merck (MRK) announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA, an investigational Lm-LLO immunotherapy, and Keytruda, the first anti-PD-1 therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer, or mCRPC. The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxis's lead Lm-LLO immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer. ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as immuno-oncology therapies. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. The results from KEYNOTE-046 will determine the future clinical development program for the combination.
07:04 EDTMRKMerck's investigational Hep C therapy granted breakthrough therapy designations
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April 7, 2015
15:44 EDTNVONovo Nordisk announces FDA accepts Tresiba, Ryzodeg resubmissions for review
Novo Nordisk announced that the U.S. FDA has accepted for review the Class II Resubmissions for Tresiba and Ryzodeg. To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data. This team has prepared the interim analysis for the Class II resubmission and will interact with the FDA during the review, on matters related to the interim analysis. As previously communicated, the result of an interim analysis carries a higher level of uncertainty than the final study results as this preliminary estimate is built on a substantially lower number of observations. Accordingly, the relative risk estimate derived from the interim analysis is thus only an indication of the final trial results. Novo Nordisk management does not have access to the results of the interim analysis. The trial is expected to be completed in the second half of 2016.
07:14 EDTMRK, BMYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
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