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Stock Market & Financial Investment News

News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
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September 30, 2014
08:01 EDTGSKGE Healthcare to collaborate with GlaxoSmithKline in commercial oncology testing
GE Healthcare (GE) announced an agreement between its affiliate, Clarient Diagnostic Services, and GlaxoSmithKline (GSK). The collaboration aims to improve access to diagnostic testing for cancer patients by establishing a network of clinical laboratories to identify genetic mutations associated with different tumour types. The collaboration will enable GE to develop a broader laboratory and data analytics service that will enable better efficiency in the healthcare market related to oncology precision medicine. This will be made available as a subscription-based service and operated by GE Healthcare. Under terms of the agreement with GSK, GE Healthcare, through its Clarient affiliate, will initially use its clinical laboratory, pathology and genomics expertise, to certify laboratories and generate diagnostic data on metastatic melanoma patients. The first Clarient certified laboratories to initiate this work, are expected to be operational in several countries in early 2015. Laboratory testing will initially focus on more than 70 mutations relevant to melanoma, including BRAF V600E and V600K, with the opportunity to expand testing beyond melanoma into other tumor types, as the network of clinical laboratories develops.
07:30 EDTGSK, SNY, PFE, NVS, JNJSachs Associates to hold a conference
14th Annual Biotech in Europe Forum for Global Partnering and Investment to be held in Basel, Switzerland on September 30-October 1.
07:29 EDTPFEMichBio to hold a conference
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07:10 EDTSHPGAbbVie plans to move forward with Shire deal despite inversion changes, WSJ says
AbbVie (ABBV) CEO Richard Gonzalez has told Shire (SHPG) employees that the company's $54B acquisition of Shire will move forward despite the recent Treasury inversion changes, the Wall Street Journal reports. The executive says AbbVie is aiming to close the deal in Q4. Reference Link
06:14 EDTPFEAstraZeneca shifting focus to cancer, diabetes, Nikkei reports
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05:16 EDTSNYRegeneron, Sanofi announce positive Phase 2 top-line dupilumab results
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that a Phase 2a proof-of-concept study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps, or CSwNP, who did not respond to intranasal corticosteroids. In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score, the primary endpoint of the study. Statistically significant improvements in all secondary efficacy endpoints were also observed, including objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms. In a pre-specified exploratory analysis, dupilumab-treated patients who also had asthma demonstrated significant improvements in asthma control. The safety profile was consistent with previous studies. The most common AEs with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.
September 29, 2014
20:01 EDTPFEPfizer, Kyowa Hakko Kirin to collaborate on immuno-oncology combination study
Pfizer and Kyowa Hakko Kirin announced that they have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s PF-05082566, an investigational, fully humanized monoclonal antibody that stimulates signaling through 4-1BB, a protein involved in regulation of immune cell activation, proliferation and survival, with Kyowa Hakko Kirin’s anti-CCR4 antibody mogamulizumab, which suppresses some of the immune cells that shield the tumor from the immune system, in a Phase Ib clinical study evaluating the safety and tolerability of the combination in patients with solid tumors. Under the terms of the agreement, Pfizer and Kyowa Hakko Kirin will co-fund the clinical study, which will be conducted by Pfizer. This study is expected to establish a recommended dose regimen and assess the safety and preliminary efficacy of the combination. This study is expected to begin in 2015 and the results will determine the future clinical development of the combination.
13:47 EDTGSKGlaxoSmithKline reports 45% survival rate of Tafinlar-treated melanoma patients
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08:55 EDTCELGCelgene price target raised to $115 from $100 at RBC Capital
RBC Capital increased its price target on Celgene (CELG) as the firm now estimates that the company's new oral Crohn's disease drug GED-0301 will generate $1B in sales. The firm expects Celgene's stock to rise further as it predicts that Phase II data for the company's Crohn's treatment will be much better than the data for AbbVie's (ABBV) Crohn's treatment, Humira. RBC predicts that Celgene's long-term 2020 guidance will beat expectations if the company is able to reach a legal settlement with Actavis (ACT.). RBC Capital keeps an Outperform rating on Celgene.
08:22 EDTBMYBristol-Myers says EMA validates MAA for Nivolumab in NSCLC
Bristol-Myers Squibb announced that the European Medicines Agency has validated for review the Marketing Authorization Application for nivolumab in non-small cell lung cancer– the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type. The MAA submitted to the EMA in lung cancer is based on data from the Phase 2 study of nivolumab in third-line pre-treated squamous cell NSCLC. In addition to the MAA for lung cancer in the E.U., the company previously announced that it has initiated a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end.
08:07 EDTNVSPhase 2 trial of binimetinib in NRAS melanoma shows promising clinical activity
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07:26 EDTMRK, PFE, GSK, BMY, CELG, SHPGInforma Business Information to hold a conference
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05:44 EDTMRKMerck announces early data from investigational use of KEYTRUDA
Merck announced the first presentation of data on the investigational use of KEYTRUDA, the company’s anti-PD-1 therapy, in PD-L1 positive, advanced urothelial cancer. The early findings presented showed a confirmed overall response rate of 24% with KEYTRUDA as monotherapy, as measured by RECIST v1.1, central review including a complete response rate of 10%. At the time of analysis, response durations ranged from 16+ to 40+ weeks with six of the seven responders continuing on therapy. In the ongoing study, 64% of patients screened had tumors that were determined to be positive for PD-L1 expression.
05:32 EDTBMYBristol-Myers announces positive Phase 3 data for Opdivo
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September 28, 2014
16:29 EDTPFEPfizer's Xalkori shrunk tumors in patients with genetic mutation, Bloomberg says
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12:53 EDTMRKMerck announces first presentation of data on investigational use of KEYTRUDA
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September 26, 2014
16:55 EDTSHPG, PFEMarket ends week lower after inversion crackdown, mixed data
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16:20 EDTBMYBristol-Myers announces multiple regulatory milestones for Opdivo in U.S., EU
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09:49 EDTSHPGAbbVie considering $7B more in financing for Shire agreement, Bloomberg says
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09:21 EDTSHPGAbbVie considering $7B more in financing for Shire deal, Bloomberg reports
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