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March 19, 2013
05:55 EDTLLY, LLY, LLY, DNA, DNA, DNA, BMY, BMY, BMY, PFE, PFE, PFE, RHHBY, RHHBY, RHHBY, BIIB, BIIB, BIIB, JAZZ, JAZZ, JAZZ, SNY, SNY, SNY, GILD, GILD, GILD, CORT, CORT, CORT, HZNP, HZNP, HZNPDrug Information Association to host a forum
Medical & Scientific Communications 2013 Annual Forum is being held in Chandler, Arizona on March 19-21.
News For LLY;CORT;GILD;SNY;JAZZ;BIIB;RHHBY;PFE;BMY;DNA;HZNP From The Last 14 Days
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July 16, 2014
07:05 EDTLLYEli Lilly and Immunocore partner to develop cancel therapies
Eli Lilly and Immunocore today announced they have entered into a co-discovery and co-development collaboration to research and potentially develop novel T cell-based cancer therapies. Immunocore will receive an upfront fee of $15M per program for the discovery of novel ImmTACs against jointly-selected cancer targets in order to generate preclinical candidate packages. If Lilly accepts a preclinical candidate package to develop and potentially commercialize, Immunocore will receive an opt-in fee of $10M and will have an option to continue co-development with Lilly on a cost-sharing and profit-sharing basis. If Immunocore does not exercise its option, it will be entitled to potential future significant milestone and royalty payments.
07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
06:26 EDTBMY, RHHBYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
11:13 EDTBMY, LLYPerrigo retreats after analyst sees limited potential buyers
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08:06 EDTLLYAnthera Pharmaceuticals to host conference call
Management discusses the acquisition of Sollpura (liprotamase) for Exocrine Pancreatic Insufficiency from Eli Lilly & Company on a conference call to be held on July 15 at 8:30 am.
07:35 EDTLLY, BMYPerrigo potential buyers list could be limited, says Jefferies
After Globes reported that Perrigo retained an investment bank to assist with a potential merger, Jefferies says the list of potential buyers could be limited since the store brand business is fundamentally a high volume, lower margin model. The firm notes U.S. companies that currently do not have large over-the-counter divisions include Bristol-Myers (BMY), Eli Lilly (LLY) and Merck (MRK). Jefferies views the merger speculation surrounding Perrigo as not surprising given the company's strong long-term fundamentals and attractive Irish domicile. It has a Buy rating on the stock with a $160 price target.
05:47 EDTLLYEli Lilly announces results from five datasets from Alzheimer's disease study
Eli Lilly announced results from an analyses of five datasets evaluating the relationship between cognitive and functional impairment in patients with mild Alzheimer's disease in the natural course of the disease. Analysis findings demonstrate that cognitive deficits predict subsequent functional deficits and suggest that cognitive decline experienced by patients is followed by an observable related decline in function, consistent with previously proposed hypotheses. These data were presented today at the Alzheimer's Association International Conference 2014 in Copenhagen, Denmark as part of the featured research session, "Statistics in the Race against Alzheimer's Disease." Hong Liu-Seifert, Ph.D., study research advisor at Eli Lilly stated, "These data support the concept that decline in cognition is later reflected in changes in function. This suggests that with treatments that target the underlying neuropathology of disease, effects on function may take longer to observe in clinical studies. Currently available scales were not developed to assess subtle functional changes or treatment effects on these deficits in patients with early or mild Alzheimer's disease, and there is debate as to how much variability exists in these scales globally. Therefore, we support discussion of alternative ways to demonstrate clinical meaningfulness in early or mild Alzheimer's disease."
05:37 EDTRHHBYGenentech Avastin granted priority review by FDA
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July 14, 2014
16:45 EDTLLYAnthera Pharmaceuticals acquires Sollpura from Eli Lilly
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11:20 EDTRHHBYExelixis seen as potential target for Roche, TheStreet says
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10:16 EDTHZNPHorizon Pharma management to meet with JMP Securities
Meeting to be held in the Mid-Atlantic area on July 17 hosted by JMP Securities.
09:28 EDTGILDCentene best positioned Medicaid pure play to post Q2 EPS beat, says Sterne Agee
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07:23 EDTLLYAlzheimer's Association to hold a conference
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July 13, 2014
13:11 EDTLLYLilly study finds combination therapy better in removing amyloid-beta protein
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July 11, 2014
15:59 EDTGILDOptions Update; July 11, 2014
iPath S&P 500 VIX Short-Term Futures down 33c to 28.25. Option volume leaders: AAPL C GILD X FB GOOG AMZN TWTR TSLA according to Track Data.
09:48 EDTGILDSenators make new request to Gilead for Sovaldi pricing details
Senate Finance Committee Chairman Ron Wyden and senior Finance Committee member Chuck Grassley made public their request for detailed pricing information on Gilead's Sovaldi, a Hepatitis C virus drug. Wyden and Grassley have asked Gilead Sciences for information about Sovaldi, a drug developed to treat and cure HCV, they disclosed, stating, “Given the impact Sovaldi’s cost will have on Medicare, Medicaid and other federal spending, we need a better understanding of how your company arrived at the price for this drug." Reference Link
07:37 EDTGILDAmerican Enterprise Institute holds a discussion
Discussion entitled, "How Will We Pay for Cost of Cures" focuses on improving the development of transformative medicines and developing financing mechanisms to pay for them and is being held in Washington, D.C. on July 11 at 8 am. Webcast Link
07:36 EDTGILDJohnson & Johnson Q2 EPS likely to exceed expectations, says Bernstein
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July 10, 2014
12:43 EDTBMYBristol-Myers announces plans for Q3 submission of Opdivo BLA
Bristol-Myers Squibb announced earlier that, following discussions with the FDA, the company is planning a Q3 submission of a Biologics Licensing Application for Opdivo for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S. “We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb. The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy and, if BRAF-mutation positive, a BRAF inhibitor regimen. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trade name for nivolumab.
10:02 EDTRHHBYRoche unit, Merck KGaA to develop companion test for cancer treatment
Ventana Medical Systems, a member of the Roche Group (RHHBY), announced it has entered into an agreement with Merck KGaA (MKGAY), which operates as EMD Serono in the United States and Canada, to collaborate with Merck KGaA's biopharmaceutical division on the development and commercialization of a companion diagnostic for an undisclosed target using Ventana's proprietary diagnostic assays.
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