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February 3, 2013
14:25 EDTMDT, BMY, AZN, RHHBY, STJ, MRK, PFE, GSK, BSX, LLY, SNY, JNJDrug, medical device makers must disclose doctor payments, Bloomberg says
Payments from drugmakers and medical device companies to doctors must be disclosed to the U.S. government beginning next March, says Bloomberg. Reference Link
News For RHHBY;JNJ;GSK;AZN;SNY;PFE;BMY;LLY;MRK;MDT;BSX;STJ From The Last 14 Days
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November 17, 2014
09:22 EDTPFEOn The Fly: Pre-market Movers
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09:08 EDTBSXBoston Scientific announces first U.S. procedures with Symphion completed
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08:57 EDTMDTMedtronic volatility elevated into Q2 and outlook
Medtronic November call option implied volatility is at 28, December is at 21, January is at 19, February is at 18; compared to its 26-week average of 19 according to Track Data, suggesting large near term price movement into the expected release of Q2 results on November 18.
08:34 EDTMRKMerck says IMPROVE-IT met primary endpoint
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08:13 EDTBMY, PFEPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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08:10 EDTBMYBristol-Myers presents results from Phase IIIb AVERT trial at ACR
Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase IIIb AVERT trial that investigated the use of Orencia plus methotrexate in biologic and MTX-naïve citrullinated protein-positive early moderate to severe rheumatoid arthritis patients. These data were presented this week at the American College of Rheumatology 2014 annual meeting. Orencia is currently indicated in adults for moderate to severe RA. Orencia should not be administered with tumor necrosis factor antagonists and should not be used with other biologic RA drugs. One of the analyses looked at anti-CCP antibodies, which are a marker of RA and may contribute to disease progression. The analysis assessed the development of anti-CCP antibodies in patients with early rapidly progressing RA by measuring isotypes and the number of epitopes recognized after treatment with Orencia plus MTX, Orencia alone, or MTX alone. Results demonstrated Orencia plus MTX numerically reduced the concentrations of all CCP isotypes and the average number of epitopes recognized over one year of treatment more than Orencia alone or MTX alone. Over 12 months of treatment, 6.7 percent, 12.1 percent, and 7.8 percent of patients on Orencia plus MTX, Orencia alone, and MTX alone, respectively, experienced a serious adverse event and 1.7 percent, 4.3 percent and 2.6 percent led to discontinuation. Serious infections were observed in 0.8 percent of patients in the combination arm and 3.4 percent in the Orencia monotherapy arm. None of the patients in the MTX alone arm experienced a serious infection. Malignancies were reported in 0.8 percent, 1.7 percent, and 0 percent of patients in the Orencia + MTX, Orencia, and MTX arms, respectively. Additionally at ACR, investigators presented 12-month efficacy data from AVERT, including new results assessing the effect of Orencia on more clinically stringent remission criteria than DAS-defined remission, as well as new MRI data. Significantly more patients on Orencia plus MTX achieved the stringent clinical endpoint of Boolean-defined remission at 12 months.
07:16 EDTJNJ, AZN, PFE, SNYMilken Institute--Faster Cures to hold a conference
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07:08 EDTAZNMedImmune presents positive Phase IIb data for mavrilimumab in RA
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07:07 EDTAZNMedImmune presents new data in systemic lupus
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06:43 EDTPFE, AZNAstraZeneca, 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.
05:30 EDTRHHBYInovio, Roche terminate collaboration for INO-5150
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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
14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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14:08 EDTMDTDaVita announces collaboration with Medtronic
DaVita Kidney Care, a division of DaVita HealthCare Partners (DVA) and leading provider of kidney care services, announced a collaboration with Medtronic (MDT) to better understand cardiovascular health in end stage renal disease, ESRD patients. The collaboration will focus on developing a pilot program using Medtronic's Reveal LINQ Insertable Cardiac Monitoring system to identify cardiac arrhythmias in patients receiving dialysis. "Medtronic recently announced data at the American Society of Nephrology meeting that showed a higher incidence of arrhythmias in patients receiving hemodialysis," said Ven Manda, vice president, Renal Care Solutions at Medtronic. "We are pleased to pursue this collaboration with DaVita to monitor more patients and gather additional data that will further our understanding of the relationship between dialysis and cardiac events in ESRD patients." "Given the high incidence rate of cardiovascular disease and events in ESRD patients, we believe that by collaborating with Medtronic, we can gain knowledge to help improve the lives of ESRD patients," said Mahesh Krishnan, vice president for clinical innovation and public policy for DaVita HealthCare Partners. "Through the collaboration we expect to utilize innovative monitoring technology and data from our DaVita Kidney Care information systems across the country. This effort is poised to improve the lives of patients by proactively detecting and preventing cardiac complications."
13:36 EDTAZNAstraZeneca presents data from studies of lesinurad combined with allopurinol
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13:26 EDTMRKMerck: KEYTRUDA showed superiority to chemotherapy for primary endpoint of PFS
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13:07 EDTBMYBristol-Myers announces results from CheckMate -066 study
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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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