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Stock Market & Financial Investment News

News Breaks
April 29, 2014
07:59 EDTAZN, SNY, ABBV, PFE, AMGNAnalyst sees Amgen, AbbVie as alternate Astra partners, Bloomberg says
Citigroup analyst Andrew Baum contended yesterday that AstraZeneca (AZN) could seek a merger of equals with Amgen (AMGN) or AbbVie (ABBV) as an alternative to the deal proposed by Pfizer (PFE), or that others like Sanofi (SNY) could make rival unsolicited bids, reported Bloomberg. Note that a later Bloomberg report claimed that Amgen is not interested in making a bid for AstraZeneca. Reference Link
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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
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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December 5, 2014
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 EDTAZNUBS European pharmaceuticals analysts holds analyst/industry conference call
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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
11:12 EDTSNYSanofi diabetes sales head left company, Bloomberg says
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09:01 EDTABBVVA negotiated $594 per dose price for Gilead HCV treatment
A Veterans Health Administration official told a Senate committee yesterday that Veterans' Affairs has "moved rapidly to deploy new, more effective, less toxic HCV treatments and has been able to negotiate significant discounts for these newer therapies." The agency negotiated a price of $594 per dose for Gilead's (GILD) Hepatitis C virus drug Sofosbuvir, below the commercial price of $1,000 per dose, VHA Chief Consultant for Pharmacy Benefits Management Michael Valentino told the Senate's Committee on Veterans' Affairs. The agency also received a $413 per dose price for Johnson & Johnson's (JNJ) Simeprevir, below the commerical price of $790. The VA has approximately 174,000 veterans in care with HCV, making it the largest single HCV provider in the U.S., Valentino pointed out. He added, "Like the rest of the country, VA has treated only a portion of Veterans for HCV because treatment and cures have been difficult to achieve due to low efficacy and high toxicity of standard drug therapies." Reference Link
08:45 EDTABBV, AZN, PFEAbbVie 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
19:11 EDTAZNAstraZeneca, Shire interested in Ariad, Daily Mail reports
Ariad (ARIA) is trading higher on speculation that both AstraZeneca (AZN) and Shire (SHPG) are interested in the company with the possibility of an ensuing auction, according to the Daily Mail, which added that analysts see an acquisition price for Ariad of more than $20 per share. Reference Link
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.
15:32 EDTSNYSanofi whistleblower suit filed over alleged kickbacks, CNBC reports
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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.
08:11 EDTSNYSanofi says Lemtrada now available in U.S. two weeks post approval
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07:16 EDTPFEFood & Drug Law Institute to hold a conference
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