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News Breaks
September 23, 2013
04:55 EDTGSK, GSK, GSK, IRWD, IRWD, IRWD, PFE, PFE, PFE, MRK, MRK, MRK, REGN, REGN, REGN, LLY, LLY, LLY, BMY, BMY, BMY, ALNY, ALNY, ALNY, LIFE, LIFE, LIFE, BIIB, BIIB, BIIB, AZN, AZN, AZN, SCLN, SCLN, SCLNElsevier Business Intelligence to hold a conference
Pharmaceutical Strategy Conference is being held in New York on September 23-25.
News For GSK;AZN;BIIB;LIFE;ALNY;BMY;LLY;REGN;MRK;PFE;IRWD;SCLN From The Last 14 Days
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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.
07:24 EDTBIIBNeurotechnology 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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06:57 EDTALNYAlnylam added to short-term buy list at Deutsche Bank
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.
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 Pfizer’s 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.
07:31 EDTBIIBBiogen to present data on neurological disease therapies at AAN meeting
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07:14 EDTBMY, BIIB, GSK, AZN, LLY, MRK, PFEEyeforpharma 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
16:17 EDTBMYOn The Fly: Closing Wrap
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12:44 EDTBMYOn The Fly: Midday Wrap
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12:13 EDTBMYuniQure price target raised to $40 from $35 at Piper Jaffray
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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 Catalyst’s 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.
08:13 EDTBMYCelldex announces initiation of Phase 1/2 study of Varlilumab combination
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07:33 EDTBMYBristol-Myers announces strategic collaboration with uniQure
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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.
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