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News Breaks
May 13, 2014
10:25 EDTABBV, ABBV, ABBV, RHHBY, RHHBY, RHHBY, PFE, PFE, PFE, PBYI, PBYI, PBYI, NVS, NVS, NVS, MDVN, MDVN, MDVN, LLY, LLY, LLY, JNJ, JNJ, JNJ, GSK, GSK, GSK, CLVS, CLVS, CLVS, CLDX, CLDX, CLDX, BMRN, BMRN, BMRN, AZN, AZN, AZN, AMGN, AMGN, AMGN, TSRO, TSRO, TSROLeerink pharma and biotech analysts hold an analyst/industry conference call
Biotech and Pharmaceuticals Analysts provide updates on breast cancer, in conjunction with the upcoming ASCO Annual Meeting, on an Analyst/Industry conference call to be held on May 20 at 11 am.
News For ABBV;AMGN;AZN;BMRN;CLDX;CLVS;GSK;JNJ;LLY;MDVN;NVS;PBYI;PFE;RHHBY;TSRO From The Last 14 Days
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August 21, 2014
07:47 EDTPFE, AZNPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
07:12 EDTLLYEli Lilly announces results from pivotal UNCOVER studies for ixekizumab
Eli Lilly announces that its investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase 3 studies. Patients treated with both dosing regimens of ixekizumab had significantly greater levels of skin clearance compared to placebo and to etanercept at the 12-week endpoint. Skin clearance was measured by standard primary endpoints for psoriasis studies: the Psoriasis Area and Severity Index and the Static Physician Global Assessment. For patients treated with ixekizumab either every four weeks or every two weeks, between 78 to 90 percent of patients achieved at least a 75 percent reduction in PASI score at 12 weeks. Additionally, 31 to 41 percent of these patients achieved PASI 100, or clear skin, at week 12. For comparison, between 5 to 7 percent of patients treated with etanercept in the UNCOVER-2 and 3 studies achieved PASI 100. Adverse events were comparable for patients receiving ixekizumab in the 12-week, randomized control portion across all three studies.
05:42 EDTJNJ, AZNIllumina 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.”
August 20, 2014
15:35 EDTGSKGlaxoSmithKline receives FDA approval for Arnuity Ellipta in the U.S.
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12:06 EDTNVSNovartis treatment for pigmented villonodular synovitis gets orphan designation
According to a post on the FDA's website, Novartis' recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor received orphan designation. Reference Link
11:44 EDTGSKMylan completes second bidding round for GSK prescription portfolio, WSJ says
Mylan (MYL), TPG Capital, Advent International, KKR (KKR), Warburg Pincus and a few Indian prescription manufacturers have completed the second round of bidding for GlaxoSmith Kline's (GSK) portfolio of mature medications, according to The Wall Street Journal, citing people familiar with the sales process. GSK noted that it aims to sell a portfolio of drug brands in the U.S. and EU with yearly sales of approximately $1.66B. Reference Link
08:30 EDTGSKPernix closes acquisition of Treximet
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08:29 EDTGSKPernix Therapeutics to host conference call
Conference call to discuss acquisition of Treximet will be held on August 20 at 9 am. Webcast Link
08:04 EDTGSKPOZEN announces U.S. rights for Treximet acquired by Pernix Therapeutics
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08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
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05:17 EDTNVSNovartis provides drug candidate compounds to TB Alliance
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August 19, 2014
07:01 EDTAZNDOJ closes investigation into PLATO Brilinta clinical trial, plans no action
AstraZeneca today announced that it has received confirmation from the United States Department of Justice that it is closing its investigation into PLATO, a clinical trial with BRILINTA tablets. The government is not planning any further action. Pascal Soriot, CEO, said: “We welcome the Department of Justice’s decision not to pursue further action. We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit BRILINTA offers to patients around the world suffering from acute coronary syndrome. As one of AstraZeneca’s growth platforms, we remain committed to delivering the full potential of this important medicine.” As part of our continued commitment to advancing the science behind cardiovascular medicine, AstraZeneca has initiated a clinical trial program for BRILINTA, its largest program involving more than 80,000 patients worldwide.
05:11 EDTAMGN, NVSGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
17:37 EDTLLYFDA grants tentative approval for Lilly, Boehringer Basaglar insulin
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17:25 EDTAMGNAmgen announces AMG 416 study met its primary and all secondary endpoints
Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism, SHPT, in patients with chronic kidney disease,CKD, receiving hemodialysis, met its primary and all secondary endpoints. "The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
11:41 EDTPFE, JNJ, MDVN, LLYCubist rises after report sparks takeover interest speculation
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08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
07:57 EDTPFE, AZNCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
07:35 EDTNVSApricus Biosciences launches topical ED treatment in Germany
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August 17, 2014
13:40 EDTRHHBYChugai makes statement denying media reports on Roche deal
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