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August 20, 2014
08:02 EDTCELG, BMYBristol-Myers, Celgene enter collaboration agreement for OPDIVO, ABRAXANE
Bristol-Myers Squibb (BMY) and Celgene (CELG) announced the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, OPDIVO and Celgene’s nab technology-based chemotherapy ABRAXANE in a Phase I study. Multiple tumor types will be explored in the study including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer. The proprietary name OPDIVO has been proposed in the U.S. and other countries, but remains subject to health authority approval. The study, which is expected to begin in 4Q14, will be conducted by Celgene. Patients with HER-2 negative breast cancer will be treated with ABRAXANE and OPDIVO, patients with NSCLC will be treated with the combination of ABRAXANE, carboplatin and OPDIVO, and patients with pancreatic adenocarcinoma will be treated with ABRAXANE, gemcitabine and OPDIVO. Additional details of the collaboration were not disclosed.
News For BMY;CELG From The Last 14 Days
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March 2, 2015
09:28 EDTBMYBristol-Myers says FDA accepts Yervoy sBLA for review
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07:20 EDTBMYCowen to hold a conference
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February 27, 2015
13:35 EDTBMYBristol-Myers reports FDA accepts BLA for Opdivo
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08:29 EDTBMYBristol-Myers price target raised to $78 from $70 at Argus
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07:37 EDTCELGCelgene removed from the short-term buy list at Deutsche Bank
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February 26, 2015
15:23 EDTBMYBristol-Myers reports ALLY trial demonstrates 97% hepatitis C cure rates
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08:35 EDTBMYBristol-Myers says BMS-966176 Phase IIa study met primary endpoint
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February 25, 2015
13:44 EDTCELGCelgene price target raised to $155 from $130 at Argus
Argus increased its price target on Celgene as the firm thinks the company is "well on its way" to meeting its growth targets. The firm thinks the company reported strong Q4 results and keeps a Buy rating on the shares.
08:36 EDTBMYBristol-Myers announces data from Phase IIb BMS-663068 trial
Bristol-Myers Squibb Company announced data from a Phase IIb trial of investigational compound BMS-663068, designed as an HIV-1 attachment inhibitor, in treatment-experienced HIV-1 patients. In the study, which compared BMS-663068 to a pharmacoenhanced protease inhibitor, virologic response rates and immunologic reconstitution were similar across the BMS-663068 and Reyataz/ritonavir arms of the trial through 48 weeks. Specifically, 61-82% of BMS-663068 patients had HIV-1 RNA levels <50 c/mL, compared to 71% of Reyataz/ritonavir patients at week 48. HIV-1 RNA levels <50 c/mL typically indicate virus replication is undetectable. Treatment with BMS-663068 resulted in no dose response safety signals, no treatment discontinuations related to adverse events, and no treatment-related serious adverse events over the course of the trial. The most common AEs were headache and abdominal pain. Due to the positive results seen thus far, a Phase III clinical trial of the attachment inhibitor among heavily treatment-experienced patients began on Monday, February 23, 2015. For the purposes of the Phase III trial, heavily treatment-experienced patients are defined as individuals who can no longer formulate a viable regimen due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications. The Phase IIb study results, presented yesterday at the 22nd Conference on Retroviruses and Opportunistic Infections, highlight the novel mechanism of action of the investigational prodrug BMS-663068, which when converted into its active moiety BMS-626529, is designed to bind directly to the HIV gp120 protein, and prevents initial viral attachment to the host CD4+ T cell and entry into the host immune cell.
February 24, 2015
08:04 EDTCELGCelgene reports Abraxane now reimbursed in Italy as first-line treatment
Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, announced that Italian authorities have issued a positive decision for NHS reimbursement of ABRAXANE -- paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel -- in combination with gemcitabine, for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, or pancreatic cancer. The reimbursement decision has been published in the Italian Official Gazette no. 30, dated February 6, 2015.
07:46 EDTBMYJacobs Engineering awarded contract from Bristol-Myers
Jacobs Engineering Group (JEC) announced that it received a contract from Bristol-Myers Squibb Company (BMY) to provide architectural and engineering services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. The facility is being designed to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
07:31 EDTCELGRBC Capital to hold a conference
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February 23, 2015
12:21 EDTBMYOn The Fly: Midday Wrap
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08:15 EDTBMYRigel Pharmaceuticals and Bristol-Myers announces R&D collaboration agreement
Rigel Pharmaceuticals (RIGL) and Bristol-Myers (BMY) announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel's extensive portfolio of small molecule TGF beta receptor kinase inhibitors. TGF beta can promote tumor growth, broadly suppress the immune system and increase the ability of tumors to spread in the body. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system's activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Bristol-Myers Squibb's Opdivo and Yervoy. Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel's TGF beta library, including, but not limited to, those approved to treat cancer. Bristol-Myers Squibb will pay $30M upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309M for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.
08:06 EDTBMYBristol-Myers, Rigel enter R&D agreement for TGF beta receptor kinase inhibitors
Rigel Pharmaceuticals (RIGL) and Bristol-Myers Squibb (BMY) announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel’s extensive portfolio of small molecule TGF beta receptor kinase inhibitors. TGF beta can promote tumor growth, broadly suppress the immune system and increase the ability of tumors to spread in the body. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system’s activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Bristol-Myers Squibb’s Opdivo, or nivolumab, and Yervoy, or ipilimumab. Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel’s TGF beta library, including, but not limited to, those approved to treat cancer. Bristol-Myers Squibb will pay $30M upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309M for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.
08:01 EDTBMYBristol-Myers to acquire Flexus, potential total consideration may be $1.25B
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February 20, 2015
16:03 EDTCELGOptions Update; February 20, 2015
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09:38 EDTCELGActive equity options trading on open
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07:23 EDTBMYAbbVie replaces Pfizer as top global pharma pick at Jefferies
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05:27 EDTCELGCelgene Revlimid approved by EC
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