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February 5, 2014
06:44 EDTAMGN, PFE, MRK, INCYMerck signs three clinical collaboration agreements to evaluate MK-3475
Merck (MRK) announced it has signed three separate clinical collaboration agreements, through subsidiaries, with Amgen (AMGN), Incyte (INCY) and Pfizer (PFE) to evaluate novel combination regimens with MK-3475, Merck's investigational anti-PD-1 immunotherapy. The financial terms of the agreements were not disclosed.
News For MRK;AMGN;INCY;PFE From The Last 14 Days
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December 8, 2014
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
16:29 EDTMRKMerck in discussions to buy Cubist for $7B, Bloomberg reports
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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 EDTAMGNAmerican Society of Hematology to hold a meeting
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12:58 EDTMRKMerck presents KEYTRUDA data at ASH
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December 5, 2014
16:40 EDTINCYDiplomat Pharmacy: FDA approves expanded indication of Jakafi
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10:22 EDTPFEBristol-Myers call activity attributed to takeover speculation
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10:05 EDTPFEBristol-Myers jumps 2% amid talk of potential Pfizer bid
Shares of Bristol-Myers (BMY) are up in early trading amid chatter of a potential takeover bid from Pfizer (PFE). The stock is up $1.26 to $60.15. Bristol's market capitalization stands around $99B, less than twice that of Pfizer's $200B. A Jefferies analyst last week called Mylan (MYL) the most likely takeover target for Pfizer. Pfizer is "highly motivated" to buy a foreign company using its overseas cash and Mylan looks like the most likely target, Jefferies analyst Jeffrey Holford wrote.
09:56 EDTPFERumor: Bristol-Myers strength attributed to takeover speculation
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09:49 EDTINCYIncyte polycythemia vera approval another upside driver, says UBS
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07:16 EDTINCYFDA PDUFA Date for Incyte's Jakafi (Ruxolitinib) is December 5, 2014
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December 4, 2014
13:26 EDTAMGNAmgen to host investor meeting
Investor meeting to be held in conjunction with the American Society of Hematology's 56t Annual Meeting in San Francisco on December 8 at 3 pm. Webcast Link
10:49 EDTINCYFDA approves Jakafi to treat polycythemia vera
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08:45 EDTPFEAbbVie price target raised to $80 from $72 at Jefferies
Jefferies raised its price target for AbbVie shares to $80 while calling the company one of its top five global pharma picks for 2015. The firm's top U.S. pick is Pfizer (PFE) and its top Europe pick is Novartis (NVS). Bayer (BAYRY) and AstraZeneca (AZN) round out the top five. Jefferies thinks AbbVie's "strong momentum" will continue into the first half of 2015 and keeps a Buy rating on the name.
December 3, 2014
17:12 EDTPFEPfizer reports positive results from PROFILE 1014 study
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16:42 EDTPFEDiplomat chosen as limited-distribution pharmacy partner by Pfizer
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15:51 EDTAMGNAmgen confirms FDA approval for BLINCYTO
Amgen announced that the FDA has granted approval of BLINCYTO for the treatment of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials. With this approval, BLINCYTO becomes the first FDA-approved bispecific CD19-directed CD3 T-cell engager antibody construct product, and the first single-agent immunotherapy to be approved for the treatment of patients with Ph- relapsed or refractory B-cell precursor ALL, the company said. BLINCYTO has a BOXED WARNING in its product label regarding Cytokine Release Syndrome and Neurological Toxicities.
13:13 EDTAMGNAmgen drug for rare form of ALL approved by FDA
The FDA said it approved Blincyto to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, an uncommon form of ALL. Blincyto carries a boxed warning alerting patients and health care professionals that some clinical trial participants had problems with low blood pressure and difficulty breathing at the start of the first treatment, or other side effects in the nervous system. The FDA approved Blincyto with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care providers about the serious risks and the potential for preparation and administration errors. Blincyto is marketed by Amgen.
07:16 EDTPFEFood & Drug Law Institute to hold a conference
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