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March 27, 2014
08:17 EDTBMY, PFEPfizer, Bristol-Myers announce results of subanalysis of Phase 3 ARISTOTLE trial
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced the results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial that assessed the effect of blood pressure control on outcomes as well as the treatment effect of Eliquis compared to warfarin according to blood pressure control.1 The results showed that poor blood pressure control was associated with a substantially higher risk of stroke or systemic embolism, independent of Eliquis or warfarin treatment. However, this subanalysis found consistent results for Eliquis versus warfarin in reducing the risk of stroke, regardless of blood pressure control. These data will be presented Saturday, March 29, at the American College of Cardiology’s 63rd Annual Scientific Session in Washington, D.C. In this subanalysis, the effect of Eliquis in reducing the risk of stroke and systemic embolism versus warfarin was consistent with the main results of the ARISTOTLE trial. Further, the effect of Eliquis in reducing the risk of stroke and systemic embolism versus warfarin was also consistent with the results of the ARISTOTLE trial in previously published subanalyses of other comorbidities, including congestive heart failure, advanced age, renal impairment and prior stroke. A total of 11 Bristol-Myers Squibb/Pfizer alliance-sponsored abstracts, including this ARISTOTLE subanalysis, were accepted for presentation at the American College of Cardiology’s 63rd Annual Scientific Session.
News For PFE;BMY From The Last 14 Days
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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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February 26, 2015
15:23 EDTBMYBristol-Myers reports ALLY trial demonstrates 97% hepatitis C cure rates
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12:31 EDTPFEPfizer says CDC recommends serogroup B meningococcal vaccine for those at risk
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08:35 EDTBMYBristol-Myers says BMS-966176 Phase IIa study met primary endpoint
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February 25, 2015
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
08:07 EDTPFEPfizer announces Trumenba studies met primary objectives
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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.
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
10:33 EDTPFEBattleground update: AbbVie named top global pick at Jefferies
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10:31 EDTPFEPfizer announces FDA acceptance of NDA for Rapamune
Pfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.
07:23 EDTPFE, BMYAbbVie replaces Pfizer as top global pharma pick at Jefferies
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February 19, 2015
18:25 EDTPFEPiper Jaffray biotech analyst to hold analyst/industry conference call
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14:49 EDTPFEWalgreens selected by Pfizer as one of pharmacies to dispense Ibrance
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07:12 EDTPFEWharton Health Care Club to hold a conference
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February 17, 2015
15:36 EDTPFETianyin JCM plans for FDA certification process
Tianyin Pharmaceutical (TPI) updated on the business and development at its Jiangchuan Macrolide Facility, or JCM, active pharmaceutical ingredients operation. In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's (PFE) and their subsidiaries in China, the company said. "This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets," Tianyin stated.
10:01 EDTPFECVS says PCSK9 inhibitors could cost system $150B annually
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