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April 23, 2014
04:55 EDTMBLTY, MBLTY, MBLTY, AZN, AZN, AZN, PFE, PFE, PFE, JNJ, JNJ, JNJ, MRK, MRK, MRK, NBS, NBS, NBS, XOMA, XOMA, XOMA, NVO, NVO, NVO, SNY, SNY, SNY, LLY, LLY, LLYGlobal Technology Community to hold a summit
7th Annual Diabetes Summit is being held in Cambridge, MA on April 23-25.
News For MBLTY;SNY;NVO;XOMA;NBS;MRK;JNJ;PFE;AZN;LLY From The Last 14 Days
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April 9, 2015
09:25 EDTLLY, MRK, JNJ, AZN, PFEPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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08:04 EDTPFEPfizer launches PCSK9 competitive grants program
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07:40 EDTNBSNeoStem announces extension of study under grant from CIRM
NeoStem announced the extension of its study under a 2014 Early Translational grant from the California Institute of Regenerative Medicine, or CIRM, for research leading to the development of a treatment for retinal diseases, including macular degeneration and retinitis pigmentosa. Under the $4M grant made to the University of California, Irvine, NeoStem is entitled, through a subaward, to $1M of new funds adding to the original $0.5M awarded. The goals of the research are to generate three-dimensional retinal tissue, to investigate the ability of adult induced pluripotent stem cells to restore sight in rodent models of retinal degeneration and to make eventual preparations for clinical use of the tissue.
April 8, 2015
09:23 EDTJNJJohnson & Johnson April volatility elevated into Q1 and outlook
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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.
07:24 EDTJNJNeurotechnology Industry Organization to hold a conference
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07:04 EDTMRKMerck's investigational Hep C therapy granted breakthrough therapy designations
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06:06 EDTAZNInovio selected by DARPA to lead $45M Ebola prevention program
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April 7, 2015
16:12 EDTAZNRegulus up 5% after RG-125 selected as clinical candidate by AstraZeneca
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16:12 EDTAZNRegulus RG-125 selected as clinical candidate by AstraZeneca
Regulus Therapeutics (RGLS) announced the selection of RG-12, a GalNAc-conjugated anti-miR targeting microRNA-103/107, or miR-103/107, for the treatment of Non Alcoholic Steatohepatitis, or NASH, in patients with type 2 diabetes/pre-diabetes, as a clinical candidate by AstraZeneca (AZN) under the companies' strategic alliance to discover, develop and commercialize microRNA therapeutics. RG-125 is the first compound from the alliance to be selected for clinical development by AstraZeneca. In connection with the candidate selection, AstraZeneca will pay Regulus $2.5M and will assume development of the program following acceptance of an Investigational New Drug application. In the near term, Regulus and AstraZeneca plan to submit key preclinical data on the RG-125 program to be presented at a scientific meeting later this year and expect to initiate a Phase I study of RG-125 in humans by the end of 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.
10:38 EDTNBSNeoStem management to meet with Philadelphia Securities Association
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08:09 EDTPFEPfizer, Merck KGaA finalize agreement to co-promote XALKORI
Merck KGaA (MKGAY) and Pfizer (PFE) announced the finalization of the co-promotion agreement allowing the companies to co-promote Pfizerís anaplastic lymphoma kinase inhibitor XALKORI. Under the agreement, XALKORI will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 in the United States, Canada, Japan and five European Union countries: France, Germany, Italy, Spain and the United Kingdom. In the U.S. and Canada, XALKORI will be co-promoted by EMD Serono, the U.S. and Canadian biopharmaceutical businesses of Merck KGaA. The second wave will begin in 2016 and includes China and Turkey. n 2015, Merck KGaA will receive a reimbursement associated with its promotion of XALKORI, followed by an 80% for Pfizer, 20% for Merck KGaA profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the U.S., Canada, Japan, France, Germany, Italy, Spain and the U.K. and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of XALKORI in countries where it is co-promoted with Merck KGaA.
07:14 EDTLLY, MRK, AZN, PFE, SNYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
07:02 EDTPFEGlycoMimetics updates on Pfizer's plans to initiate Phase 3 Rivipansel trial
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April 6, 2015
14:34 EDTJNJDepomed price target raised to $30 from $27 at Roth Capital
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10:37 EDTPFETargacept says Pfizer terminates research & license agreement with Catalyst
In a regulatory filing from earlier, Targacept (TRGT) said: "As previously reported, on March 5, Targacept, Talos Merger Sub, a Delaware corporation and a wholly owned subsidiary of Targacept and Catalyst Biosciences, entered into an Agreement and Plan of Merger, pursuant to which, among other things, subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Catalyst, with Catalyst becoming a wholly owned subsidiary of Targacept and the surviving corporation of the merger. On April 1, Catalyst notified Targacept that Pfizer (PFE) would be exercising its right to terminate in its entirety the June 29, 2009, research and license agreement between Catalyst and Wyeth, which governs the development and commercialization of Catalystís leading human Factor VIIa product candidate for the treatment of hemophilia and surgical bleeding indications. On April 2, Pfizer provided Catalyst with its formal written notice of termination of the research and license agreement. Upon the June 1, effective date of the termination, the license and certain rights under the research and license agreement will terminate and revert to Catalyst. Catalyst has informed Targacept that Pfizer is committed to an orderly transfer of data, regulatory documentation and related technology under the agreement to Catalyst to enable Catalyst to continue the clinical development of this product candidate. Targacept is currently reviewing the implications of this event on the proposed Merger. In morning trading shares of Targacept are down almost 12% to $2.51.
09:36 EDTJNJActive equity options trading on open
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07:14 EDTLLYBiodel GEM device demonstrates 'superior' usability
Biodel (BIOD) announced results from a formative human factors study of its Glucagon Emergency Management, or GEM, device, which is in development for the treatment of diabetes patients experiencing severe hypoglycemia. In the study, the GEM device demonstrated a substantial improvement in ease-of-use and successful delivery of the full dose, as well as a reduction in dosing errors, when compared to commercially available glucagon kits; Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit. Furthermore, while training and previous experience increased the success rate with the Eli Lilly and Novo Nordisk glucagon kits, it did not further impact the already high success rate with the GEM device when compared to non-experienced, untrained participants.
06:21 EDTJNJJohnson & Johnson CEO comments on Asia expansion, WSJ reports
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