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Stock Market & Financial Investment News

News Breaks
February 7, 2013
07:46 EDTAMGN, RHHBY, PFE, LLY, SNY, BIIB, CBST, JNJTerrapinn to host a conference
Clinical Outsourcing World Europe Conference is being held in London on February 6-7.
News For AMGN;RHHBY;PFE;LLY;SNY;BIIB;CBST;JNJ From The Last 14 Days
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August 21, 2014
07:55 EDTPFEActavis volatility expected to move on Pfizer considering new target report
Actavis (ACT) volatility is expected to move on Pfizer (PFE) considering other overseas alternatives, Bloomberg reports. Overall option implied volatility of 27 is near its 26-week average of 31 according to Track Data, suggesting decreasing price movement.
07:47 EDTPFEPfizer 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 EDTSNY, JNJIllumina 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
08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
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August 19, 2014
16:46 EDTSNYFDA approves Genzyme Cerdelga capsules
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05:11 EDTAMGNGamida 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, CBST, JNJ, LLYCubist rises after report sparks takeover interest speculation
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09:43 EDTCBSTCubist may receive takeover interest, Bloomberg reports
Cubist Pharmaceuticals' (CBST) focus on bacterial infections could attract takeover interest, Bloomberg reports in its Real M&A column. Reference Link
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 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 17, 2014
13:40 EDTRHHBYChugai makes statement denying media reports on Roche deal
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August 15, 2014
18:35 EDTBIIBBiogen PLEGRIDY approved in U.S. for treatment of multiple sclerosis
Biogen Idec announced that the FDA has approved PLEGRIDY, a new treatment for people with relapsing forms of multiple sclerosis, or RMS. PLEGRIDY is dosed once every two weeks and can be administered subcutaneously with the PLEGRIDY PEN, a new, ready-to-use autoinjector, or a prefilled syringe. The FDA approval of PLEGRIDY is based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 MS patients.
11:28 EDTRHHBYRoche in talks on $10B deal to buy remainder of Chugai, Bloomberg reports
Roche is in talks to purchase the 38% stake of Chugai Pharmaceutical that it doesn't already own, according to Bloomberg, citing people familiar with the matter. The potential deal is valued at approximately $10B. Though no financial decision has been made, the deal may be announced as early as next week, the sources added. Reference Link
11:02 EDTRHHBYRoche in talk on $10B deal to buy remainder of Chugai, Bloomberg says
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07:01 EDTBIIBIsis Pharmaceuticals earns $2M from advancement of ISIS-SMN from Biogen
Isis Pharmaceuticals (ISIS) announced that it has earned a $2M milestone payment from Biogen (BIIB) related to the advancement of the ongoing open-label extension study of ISIS-SMNRx in children with spinal muscular atrophy.
06:54 EDTAMGNAmgen shares should 'grind higher' this year, says RBC Capital
RBC Capital expects Amgen shares to "grind higher" this year driven by a greater appreciation of pipeline programs, the Analyst Day on October 28, an expected filing of the PCSK-9 program soon, and positive Ph iiB anti-CGRP migraine data expected year-end. Shares are Outperform rated.
06:12 EDTRHHBYGilead announced favorable ruling in arbitration against Roche
Gilead (GILD) announced that an arbitration panel determined that Roche (RHHBY) failed to establish any of their claims and ruled in favor of Gilead. As a result, Roche is not entitled to any damages or other relief. In March 2013, Roche initiated an arbitration against Gilead and Pharmasset, predecessor to Gilead Pharmasset, regarding a 2004 collaboration agreement between Roche and Pharmasset. In the arbitration demand, Roche asserted that it had an exclusive license to sofosbuvir pursuant to the collaboration agreement because sofosbuvir, a prodrug of a uridine monophosphate analog, is allegedly a prodrug of PSI-6130, a cytidine analog. Roche further claimed that, because it had exclusive rights to sofosbuvir, it also had an exclusive license to a patent covering sofosbuvir, and that we infringed that patent by selling and offering for sale products containing sofosbuvir.
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