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News Breaks
January 27, 2014
04:55 EDTFCSC, FCSC, FCSC, SNY, SNY, SNY, GSK, GSK, GSK, NVS, NVS, NVS, PFE, PFE, PFE, SAFC, SAFC, SAFC, CLDX, CLDX, CLDX, CELG, CELG, CELG, WX, WX, WX, XON, XON, XON, OPXA, OPXA, OPXA, BLUE, BLUE, BLUE, BIIB, BIIB, BIIBPhacilitate to hold a forum
Cell & Gene Therapy Forum 2014 is being held in Washington, D.C. on January 27-29.
News For FCSC;BLUE;OPXA;XON;WX;CELG;CLDX;SAFC;PFE;NVS;GSK;SNY;BIIB From The Last 14 Days
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November 17, 2014
12:48 EDTCLDXCelldex volatility decreases after positive interim update
Celldex November call option implied volatility is at 69, December is at 65, January is at 64; compared to its 26-week average of 73 according to Track Data, suggesting decreasing price movement after the company on Friday afternoon reported interim positive data for its brain tumor treatment, rindopepimut.
12:27 EDTCLDXOn The Fly: Midday Wrap
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11:49 EDTBLUEPiper Jaffray healthcare analysts to hold an analyst/industry conference call
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11:37 EDTCLDXCelldex soars after reporting results from brain tumor treatment study
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11:11 EDTCLDXHigh option volume stocks:
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11:06 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
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09:42 EDTPFEPfizer to host investor day
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09:34 EDTCLDXiPath S&P 500 VIX Short-Term Futures are recently up 19c to 28.86
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09:22 EDTPFEOn The Fly: Pre-market Movers
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08:19 EDTCLDXCelldex Rindo data looks like 'home run,' says Cowen
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08:13 EDTPFEPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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07:16 EDTSNY, BLUE, PFE, CELGMilken Institute--Faster Cures to hold a conference
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07:12 EDTCLDXCelldex data better than expected, says Cantor
Cantor believes that data from the Phase II trial of Celldex's rindopepimut in EGFRvIII-positive glioblastoma multiforme patients exceed expectations. The firm thinks the data is likely to trigger a turning point in the shares. Cantor keeps a $33 price target and Buy rating on the stock.
06:43 EDTPFEAstraZeneca, Pfizer deal seen less likely after Merck transaction, Reuters says
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05:32 EDTGSKMedidata announces collaboration with GlaxoSmithKline
Medidata (MDSO) announced the completion of a method development project conducted in partnership with GlaxoSmithKline (GSK) to evaluate the impact of unifying mobile health, or mHealth, devices with cloud-based technologies in a clinical trial setting. The joint initiative assessed the capabilities of mHealth tools and evaluated how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs. The collaborative project, which took place at GSK’s Human Performance Lab, demonstrated that mHealth technologies have the power to comprehensively collect large volumes of objective data that is reliable, secure and analysis-ready, and provides real-time, continuous insight into the well being of patients. All of the data collected was audited and is compliant with FDA regulations. Additionally, the effort indicated that mobile devices can support the long-term goal of lessening the burden on patients participating in studies by streamlining routine procedures, eliminating unnecessary ones and reducing visits to clinical trial sites.
05:27 EDTPFEPfizer lowers FY14 Reported EPS view to $1.40-$1.49 from $1.50-$1.59
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05:23 EDTPFEPfizer forms strategic alliance with Merck KGaA
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November 16, 2014
15:07 EDTNVSNovartis says arthritis drug secukinumab met primary endpoint
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14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
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