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News Breaks
August 21, 2014
05:42 EDTSNY, AZN, JNJ, ILMNIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
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November 19, 2014
06:36 EDTAZNClovis rociletinib data 'good news/bad news,' says Mizuho
Mizuho analyst Peter Lawson says his initial read of the new rociletinib data is "good news/bad news," which leaves his price target for Clovis unchanged. Lawson pegs the bad news as the drug losing its progression-free survival lead since the estimated PFS dropped from 12 months to 10.4 months, essentially in-line with AstraZeneca's (AZN) competing drug AZD9291. Lawson sees the good news as the "encouraging" PFS of 7.5 months in T790M-negative patients. He keeps a Buy rating on Clovis with a $100 price target.
06:30 EDTJNJJohnson & Johnson, Boston Scientific trial set to start tomorrow, Reuters says
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06:10 EDTILMNIllumina, USAID and Broad Institute partner to combat ebola in West Africa
Illumina, the U.S. Agency for International Development and the Broad Institute of MIT and Harvard, have entered into a public-private partnership to help combat the Ebola epidemic in West Africa with aid for those on the ground who are fighting the spread of the virus. The partnership will train local and outbreak-deployed personnel to sequence viral genomes from the outbreak, and will extend surveillance operations, as well as equip facilities in West Africa with state-of-the-art genome sequencing technology.
November 18, 2014
15:48 EDTSNYGenzyme, Isis present KYNAMRO data at AHA meeting
Genzyme, a Sanofi (SNY) company, and Isis Pharmaceuticals (ISIS) announced that new two-year data from a phase 3 long-term extension study of KYNAMRO injection was presented at a scientific session at the annual American Heart Association meeting. In the study, a retrospective analysis showed that patients treated with KYNAMRO for a mean of two years had a significant reduction in Major Adverse Cardiovascular Events compared to two years prior to therapy. The rate of MACE in patients treated with KYNAMRO for two years were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with KYNAMRO. In this analysis, MACE were identified in 62% of patients during two years prior to KYNAMRO treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with KYNAMRO.
14:59 EDTAZNRanbaxy sues FDA for rescinding approval of Nexium, Valcyte copies, Reuters says
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12:16 EDTSNYSanofi to host seminar on New Medicines
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07:29 EDTAZNPfizer less likely to pursue AstraZeneca after PD-L1 deal, says JPMorgan
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07:18 EDTAZNWoodford confident in Astra, sees 50% chance of new Pfizer bid, Reuters reports
Investment manager Neil Woodford of Woodford Investment Management said he now has an even stronger belief in AstraZeneca (AZN), citing the company's strong product pipeline, and put the chances of a new takeover bid from Pfizer (PFE) at 50/50, reported Reuters, citing a statement from Woodford. Reference Link
06:39 EDTAZNAstraZeneca: 'Hard to comment' on whether Pfizer will come back, Reuters reports
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November 17, 2014
09:37 EDTAZNAstraZeneca to host investor day
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07:16 EDTAZN, JNJ, 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 EDTAZNAstraZeneca, Pfizer deal seen less likely after Merck transaction, Reuters says
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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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13:36 EDTAZNAstraZeneca presents data from studies of lesinurad combined with allopurinol
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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”.
November 14, 2014
16:21 EDTJNJOn The Fly: Closing Wrap
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14:53 EDTJNJ, AZN, SNYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
07:14 EDTAZNAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
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