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July 25, 2014
05:35 EDTBAYRY, AMGNBayer, Onyx reports NEXAVAR Phase 3 trial did not meet primary endpoint
Bayer HealthCare (BAYRY) and Onyx Pharmaceuticals, an Amgen subsidiary (AMGN), announced that an investigational Phase 3 trial of NEXAVAR tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival. The study, called RESILIENCE, evaluated the efficacy and safety of sorafenib in combination with capecitabine, an oral chemotherapeutic agent, compared to placebo plus capecitabine, in patients with HER2-negative breast cancer who are resistant to or have failed prior taxane therapy, and resistant to or failed anthracycline or for whom further anthracycline therapy is not indicated. Based on initial review of the data, the types of adverse events observed were generally comparable with those known for either sorafenib or capecitabine. Data from this study are expected to be presented at an upcoming scientific congress.
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March 2, 2015
16:15 EDTAMGNAmgen announces launch of Neulasta Delivery Kit
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09:19 EDTAMGNLigand data should establish superiority of Kyprolis, says Roth Capital
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07:17 EDTAMGNCelimmune announces Anti-IL-15 antibody licensing, option agreements with Amgen
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March 1, 2015
19:08 EDTAMGNAmgen ENDEAVOR study demonstrates superiority of Kyprolis over Velcade
Amgen and its subsidiary Onyx Pharmaceuticals announced the results from a planned interim analysis showing that the Phase 3 head-to-head clinical trial ENDEAVOR evaluating Kyprolis, carfilzomib, for Injection in combination with low-dose dexamethasone versus Velcade, bortezomib and low-dose dexamethasone met the primary endpoint of progression-free survival, PFS. Patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade. The Kyprolis combination demonstrated superiority over the Velcade combination for secondary objectives of higher overall response rate and lower neuropathy events. Overall survival data are not yet mature and continue to be monitored. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the Phase 3 ASPIRE study. In ENDEAVOR, the rates for cardiac and renal failure were higher in the Kyprolis arm versus the Velcade arm. There was an increase in the incidence of hypertension and dyspnea in the Kyprolis arm compared to Velcade and that observed in the ASPIRE study.
February 27, 2015
09:03 EDTAMGNAmgen receives positive CHMP opinion for use of Vectibix
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix to include combination with FOLFIRI as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer. About half of the patients with mCRC have wild-type RAS tumors.The new indication is based upon the 20060314 study, which evaluated Vectibix plus FOLFIRI in the first-line setting. Vectibix is already approved in the European Union for the treatment of adult patients with wild-type RAS mCRC.
07:37 EDTAMGNAmgen removed from the short-term buy list at Deutsche Bank
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07:26 EDTAMGNFDA PDUFA Date for Amgen's Ivabradine is February 27, 2015
February 26, 2015
16:35 EDTAMGNAmgen reports EMA acceptance of Kyprolis
Amgen and its subsidiary Onyx Pharmaceuticals announced that the European Medicines Agency, or EMA, has accepted the Marketing Authorization Application, or MAA, of Kyprolis for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The MAA has been granted accelerated assessment by the EMA. Kyprolis is a proteasome inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting approximately 89,000 people in Europe. Nearly all patients with the disease experience periods of remission, followed by relapses and eventually their disease becomes resistant to treatment. The MAA includes data from the Phase 3 ASPIRE trial as well as other relevant data.
11:36 EDTBAYRYBayer sees FY15 sales EUR 46
The company expects positive currency effects on sales of about 3% compared with the previous year. Bayer plans to raise EBITDA before special items by a low- to mid-teens percentage, allowing for expected positive currency effects of about 2 percent. Bayer aims to increase core earnings per share by a low-teens percentage, allowing for expected positive currency effects of around 3%.
11:35 EDTBAYRYBayer reports FY14 net income EUR 3.43B vs. EUR 3.19B last year
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06:30 EDTBAYRYBayer says flotation of MaterialScience 'proceeding on schedule'
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February 25, 2015
16:50 EDTAMGNAmgen reports positive results from head-To-head Phase 3 study
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February 20, 2015
07:23 EDTBAYRYAbbVie replaces Pfizer as top global pharma pick at Jefferies
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06:29 EDTBAYRYBayer close to selling diabetes unit to Panasonic, Bloomberg says
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February 19, 2015
18:25 EDTBAYRYPiper Jaffray biotech analyst to hold analyst/industry conference call
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16:50 EDTBAYRYSanofi appoints Olivier Brandicourt CEO
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14:53 EDTBAYRYBayer near sale of diabetes unit to KKR backed venture, Bloomberg says
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14:01 EDTBAYRYBayer near sale of diabetes unit to KKR's Panasonic Healthcare, Bloomberg says
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February 17, 2015
18:17 EDTAMGNJANA Partners gives quarterly update on stakes
NEW STAKES: NCR (NCR), Liberty Ventures (LVNTA), Solarcity (SCTY), Computer Sciences Corp (CSC), Salix (SLXP), and Applied Materials (AMAT). INCREASED STAKES: Hertz (HTZ), Valeant (VRX), Walgreens Boots Alliance (WBA), Rackspace (RAX), and HD Supply (HDS). DECREASED STAKES: AIG (AIG), Actavis (ACT), Charter (CHTR), AerCap (AER), and Energy Transfer Equity (ETE). LIQUIDATED STAKES: Equinix (EQIX), Cameron International (CAM), Dollar General (DG), QEP Resources (QEP), and Amgen (AMGN).
10:01 EDTAMGNCVS says PCSK9 inhibitors could cost system $150B annually
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