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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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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, MRKBristol-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.
05:38 EDTGSKGSK, Theravance initiate Phase III IMPACT study
GlaxoSmithKline (GSK) and Theravance (THRX) announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease, or COPD. IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid, or ICS; a long-acting muscarinic antagonist, or LAMA; and a long-acting beta2-adrenergic agonist, or LABA, in patients with COPD. The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF, or fluticasone furoate, an ICS, UMEC, or umeclidinium, a LAMA, and VI, or vilanterol, a LABA, all delivered in GSK's Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta, FF/VI, which is an ICS/LABA combination, and Anoro Ellipta, UMEC/VI, which is a LAMA/LABA combination.
July 15, 2014
12:21 EDTGSKOn The Fly: Midday Wrap
Stocks on Wall Street were lower at midday despite better than expected quarterly reports from two of the nation's largest financial institutions. Stock futures improved during the pre-market trading session, leading to a higher open for the broader market, following better than expected earnings reports from JP Morgan (JPM) and Goldman Sachs (GS). The earnings news also came alongside another huge M&A deal, as tobacco giants Reynolds American (RAI) and Lorillard (LO) confirmed plans to merge. However, the major averages weakened throughout the morning and fell into negative ground against the backdrop of Fed Chair Janet Yellen giving testimony on Capital Hill. In the Board of Governors' Monetary Policy Report, the central bank said valuation metrics in "some sectors" appear substantially stretched, "particularly those for smaller firms in the social media and biotechnology industries." ECONOMIC EVENTS: In the U.S., retail sales increased 0.2% in June compared to the month prior, making for the weakest reading since January and missing the consensus forecast for an increase of 0.6%. The Empire State manufacturing index climbed to a four-year high of 25.6 in July, beating expectations for a reading of 16.5. Import prices rose 0.1% in June, with export prices slipping 0.4%. Business inventories grew 0.5% in May, which was just below the 0.6% consensus growth expectation. In Europe, Germany's ZEW survey missed expectations, as both its Current Situation and Expectations reading were lower than forecast. COMPANY NEWS: Shares of JPMorgan advanced nearly 4% after the bank reported a profit of $1.46 a share, which included a legal expense of 13c a share, beating analysts' consensus forecast of $1.29. The earnings report comes after CEO Jamie Dimon recently disclosed that he has throat cancer. During the company's conference call, Dimon said he was "feeling great," that doctors had found no evidence of cancer anywhere except in the location where it had originally been detected, and that his prognosis for recovery is "excellent"... Also in the large-cap bank sector, Goldman Sachs' headline earnings and revenue similarly beat expectations. The firm, which said it ranks first in worldwide announced and completed mergers and acquisitions for the year-to-date, advanced about 1% following its report... Along with JPMorgan in the Dow Jones Industrial Average, Johnson & Johnson (JNJ) reported quarterly sales and profits that beat expectations and the healthcare conglomerate raised its fiscal year EPS view to $5.85-$5.92 from $5.75-$5.85. However, its increased outlook range still fell short of the $5.90 per share consensus forecast that analysts had prior to its report... Reynolds American confirmed news that has been speculated for many weeks, announcing that it will acquire peer Lorillard in a cash-and-stock transaction currently valued at $68.88 per Lorillard share, or a total of $27.4B, including the assumption of net debt. Shares of both fell afterward, with Lorillard down 8% to trade near $61.75 at midday and Reynolds slipping 5%. MAJOR MOVERS: Among the notable gainers was small-cap pharma biotechnology research company Codexis (CDXS), which surged nearly 50% after announcing a collaboration and license agreement with GlaxoSmithKline (GSK). Among the noteworthy losers was Aaron's (AAN), which is engaged in the lease ownership and retail sale of a variety of consumer products. Its stock fell over 6% after the company lowered its second quarter outlook, citing lower than expected performance of its core business as the reason for the revision. INDEXES: Near midday, the Dow was down 33.45, or 0.2%, to 17,021.97, the Nasdaq was down 40.48, or 0.91%, to 4,399.94, and the S&P 500 was down 9.24, or 0.47%, to 1,967.86.
11:13 EDTBMY, MRK, LLYPerrigo retreats after analyst sees limited potential buyers
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09:21 EDTGSKOn The Fly: Pre-market Movers
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08:11 EDTMRKMerck looks to revive livestock drug Zilmax, WSJ says
Merck has been preparing to conduct a large-scale study this summer to evaluate the safety of its Zilmax feed additive, which the company pulled from the U.S. market last year over concerns in the beef industry that the drug made it difficult for some animals to walk, reported The Wall Street Journal. Reference Link
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, BMY, MRKPerrigo 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.
07:25 EDTALNYAlnylam to hold a roundtable
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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."
July 14, 2014
21:08 EDTGSKCodexis to host conference call
Conference call to discuss the strategic collaboration and license agreement with GSK will be held on July 15 at 8:30 am. Webcast Link
16:45 EDTLLYAnthera Pharmaceuticals acquires Sollpura from Eli Lilly
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16:06 EDTGSKCodexis announces $25M collaboration, license agreement with GlaxoSmithKline
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07:23 EDTLLYAlzheimer's Association to hold a conference
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06:17 EDTGSKXinhua: China indicts two GSK foreign investigators, The Guardian reports
Prosecutors in China have indicted two foreign investigators, British national Peter Humphrey and his wife, Yu Yingzeng, linked to GlaxoSmithKline, for illegally obtaining private information on Chinese citizens, reports The Guardian. Citing state media news agency Xinhua, the case is the first indictment by Chinese prosecutors against foreigners for illegal investigation. Reference Link
July 13, 2014
13:11 EDTLLYLilly study finds combination therapy better in removing amyloid-beta protein
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July 10, 2014
16:12 EDTMRKMedivation names Dawn Svoronos as Chief Commercial Officer
Medivation (MDVN) announced Dawn Svoronos has been appointed as its chief commercial officer, reporting to David Hung, M.D., founder, CEO and president of Medivation. Svoronos currently is a member of Medivation's Board of Directors and is a former president of Europe and Canada for Merck & Co. (MRK), where she oversaw commercial operations in approximately 30 EU and EU accession countries. Svoronos will lead Medivation's commercial organization on an interim basis and will participate in the company's search for a permanent chief commercial officer. Cheryl Cohen, Medivation's former chief commercial officer, has left the company to pursue other opportunities.
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.
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