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News Breaks
December 4, 2012
07:16 EDTTHLD, AMGN, GSKSome drugmakers focus on childhood cancer treatments, Bloomberg reports
Four experimental cancer treatments that may one day help gravely ill children are facing review by U.S. pediatric advisers. The medicines from GlaxoSmithKline (GSK), Amgen (AMGN) Threshold (THLD) and Boehringer Ingelheim have the potential to treat children with a variety of tumors and fast-spreading leukemia, reports Bloomberg.Reference Link
News For GSK;AMGN;THLD From The Last 14 Days
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December 18, 2014
09:21 EDTGSKOn The Fly: Pre-market Movers
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07:15 EDTGSKAgenus reports GSK ZOE-50 Phase 3 study met primary endpoint
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06:27 EDTAMGNAmgen's new leukemia drug to cost $178,000, Reuters reports
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December 17, 2014
17:47 EDTAMGNAmgen raises Q1 dividend 30% to 79c per share
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December 11, 2014
16:03 EDTAMGNAmgen, AstraZeneca to present results from Phase 3 plaque psoriasis study
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December 9, 2014
10:23 EDTGSKOn The Fly: Analyst Downgrade Summary
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09:10 EDTGSKARIAD takeover rumors rekindled, Independent says
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07:44 EDTGSK, AMGNAmerican Association for Cancer Research to hold a symposium
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05:40 EDTAMGNAmgen presents new BLINCYTO Phase 2 study data at ASH meeting
Amgen announced that new data from a pivotal Phase 2 study evaluating BLINCYTO for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia, or ALL was presented at the 56th American Society of Hematology, or ASH, Annual Meeting and Exposition. In one analysis from the '211 study, 40% of patients treated with BLINCYTO who achieved a complete remission, or CR, or complete remission with partial hematologic recovery, or CRh, were enabled to proceed to allogeneic hematopoietic stem cell transplant, or HSCT. Additionally, a secondary analysis from the study found that 82% of patients who had a CR or CRh also had a minimal residual disease, or MRD, response, a measure used to predict disease recurrence in patients with ALL. In one analysis of the '211 study, 40% of patients treated with BLINCYTO who achieved a CR or CRh were enabled to proceed to HSCT, including both patients who had received prior HSCT and patients who had not received prior HSCT. A secondary analysis of the study demonstrated that, among patients receiving BLINCYTO who had a CR or CRh and had evaluable MRD data, 82% had an MRD response, with 70% of those patients achieving a complete MRD response. Median overall survival was longer among patients who had a CR or CRh and an MRD response compared to patients who didn't have an MRD response.
05:37 EDTGSKGlaxoSmithKline downgraded to Underperform from Neutral at BofA/Merrill
BofA/Merrill downgraded GlaxoSmithKline to Underperform citing a lack of pipeline catalysts and its belief the European pharma sector is close to fair value.
December 8, 2014
16:24 EDTAMGNAmgen initiates new combination trial for talimogene laherparepvec with KEYTRUDA
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13:32 EDTGSKEpizyme announces results for PRMT5 inhibitor
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09:09 EDTAMGNAmgen announces FDA approval for XGEVA
Amgen announced that the FDA has approved a new indication for XGEVA for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA, which is reserved for drugs that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S. HCM is a serious complication in patients with advanced cancer, including those with hematologic malignancies, and indicates poor prognosis.1,2 The condition results from cancer-driven increases in bone resorption, and if untreated, can lead to renal failure, progressive mental impairment, coma and death. The approval of XGEVA is based on positive results from an open-label, single-arm study, which enrolled patients with advanced cancer and persistent hypercalcemia after recent bisphosphonate treatment. The primary endpoint was the proportion of patients with a response, defined as albumin-corrected serum calcium <11.5 mg/dLwithin 10 days after the first dose of XGEVA. Secondary endpoints included the proportion of patients who experienced a complete response (defined as CSC <10.8 mg/dL by day 10, time to response and response duration. The study achieved its primary endpoint with a response rate at day 10 of 63.6 percent in the 33 patients evaluated. The overall complete response rate was 63.6 percent. The estimated median time to response was nine days, and the median duration of response was 104 days.4,5
09:09 EDTAMGNAmgen announces FDA approval for XGEVA
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05:42 EDTAMGNSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
December 7, 2014
16:48 EDTTHLDThreshold Pharmaceuticals announces data from TH-302 study
Threshold Pharmaceuticals announced new preliminary data from the Phase 2 component of an ongoing company-sponsored Phase 1/2 trial of TH-302, the company's lead investigational anticancer drug, in combination with the proteasome inhibitor bortezomib, Velcade, and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma. The median number of prior therapies was 8. The recommended phase 2 dose of TH-302 was determined to be 340 mg/m2 and no dose limiting toxicities were observed at this dose level. Partial responses were observed in 2 of 7 evaluable patients overall and 2 of 4 evaluable patients at the recommended phase 2 dose of TH-302. These data are being presented today at the 56th ASH Annual Meeting and Exposition in San Francisco, California.
14:38 EDTAMGNAmgen announces new data from Phase 2 BLINCYTO immunotherapy study
Amgen announced new data from the Phase 2 BLAST study which evaluated the bispecific T cell engager, BiTE, immunotherapy BLINCYTO in patients with minimal residual disease, MRD, positive B-cell precursor acute lymphoblastic leukemia, ALL. In the study, 78% of patients who received BLINCYTO experienced a complete MRD response , a measure of eradication of residual disease at the molecular level, after one treatment cycle. Nearly all complete responses occurred within the first treatment cycle. The results from the BLAST study will be featured during the 56th American Society of Hematology Annual Meeting and Exposition press briefing on Saturday, December 6, at 10 a.m. PT and will be presented in an oral session at ASH on Monday, December 8, at 10:30 a.m. PT. "BLINCYTO is the most advanced of Amgen's BiTE immunotherapies, a new and innovative approach that helps the body's own immune system fight cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Achieving molecular complete remission is an important goal in the treatment of ALL, and the data presented at ASH demonstrates that BLINCYTO can produce deep responses in patients that have trace amounts of residual disease." MRD is a state of disease in which the microscopic analysis does not show malignant cells, but more sensitive techniques still detect disease at the molecular level. Patients who have persistent or recurrent MRD after their first therapy have a higher risk of relapse than those with no detectable MRD. In addition to the majority of patients achieving a compete MRD response within one cycle of treatment, 80% achieved a complete MRD response across all cycles. Responses occurred in all subgroups including older patients and patients with high MRD level; no predictive factor for MRD response was identified. In the study, adverse events of all grades occurring in 20% or more patients included pyrexia, tremor, chills, fatigue, nausea, vomiting and diarrhea. Grade =3 AEs occurring in five percent or more patients included neutropenia , pyrexia and tremor. Two fatal AEs occurred on treatment: subdural hemorrhage and pneumonitis in conjunction with influenza. Treatment interruptions due to AEs occurred in 31% of patients.
14:18 EDTAMGNAmgen, Onyx announce detailed results from Phase 3 ASPIRE study of Kyprolis
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14:10 EDTTHLD, AMGNAmerican Society of Hematology to hold a meeting
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