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July 17, 2014
08:08 EDTPFE, BMYBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced that the first patient has been enrolled into a Phase IV clinical trial called EMANATE assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation undergoing cardioversion. Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with NVAF. Cardioversion is a commonly used, effective method of converting atrial fibrillation to a normal rhythm, allowing the heart to pump more effectively. Traditionally, anticoagulation is administered for a minimum of three weeks prior to cardioversion and for four weeks afterward. In some patients, early cardioversion can be performed on the same day or within days of new-onset NVAF, usually after imaging, to confirm the absence of a pre-existing thrombus in the heart, which could be dislodged during the cardioversion procedure and cause a stroke. EMANATE, a randomized, open-label clinical trial, will assess the effectiveness and safety of Eliquis compared with usual care initiated in patients with NVAF expected to undergo cardioversion after short-term anticoagulation, in a clinical practice setting. In NVAF patients presenting at least 48 hours after the onset of NVAF, early cardioversion will be performed after excluding a thrombus by imaging, on the same day or within a few days. In NVAF patients presenting within 48 hours of the onset of NVAF, cardioversion will be performed promptly without prior imaging. In all patients, Eliquis or usual care will be initiated prior to cardioversion and continued for up to 30 days post-cardioversion. The EMANATE trial is anticipated to enroll 1,500 eligible patients from the U.S., Canada, Europe and Asia. Patients will be randomized 1:1 to Eliquis or usual care, to be administered for up to 30 days following early cardioversion or 90 days post randomization if cardioversion is not performed within this timeframe. The primary efficacy endpoints are the occurrence of acute stroke, systemic embolism and all-cause death. Primary safety endpoints are major bleeding and clinically relevant non-major bleeding.
News For BMY;PFE From The Last 14 Days
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July 2, 2015
18:37 EDTPFEViiV, Desano enter strategic manufacturing agreement for Tivicay
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16:37 EDTPFEPfizer announces FDA acceptance for review of NDA for Xeljanz
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09:31 EDTPFEXRpro Sciences acquires assets related to ion channel platform from Pfizer
XRpro Sciences announced its acquisition of assets related to the ion channel biology platform from Pfizer that had previously been obtained as part of Pfizer's 2011 acquisition of Icagen. XRPro Sciences also acquired all of Pfizer's rights to the "Icagen" name and trademark. XRPro Sciences is re-launching the Icagen brand and will provide comprehensive services for ion channel and transporter drug discovery, combining Icagen's industry-leading scientific expertise and extensive portfolio of assays and cell lines with XRpro Sciences' proprietary, label-free X-ray fluorescence technology. The new Icagen will continue to operate out of the existing facility in Research Triangle Park, North Carolina in addition to the current XRpro Sciences Inc. site in Cambridge, Massachusetts. Pfizer scientists associated with the ion channel biology platform will transition to the new Icagen, ensuring continuity of their extensive scientific expertise.
July 1, 2015
16:00 EDTPFEOptions Update; July 1, 2015
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June 26, 2015
08:31 EDTBMYAlexandria Real Estate announces lease with Bristol-Myers in Cambridge
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June 25, 2015
09:34 EDTBMYBristol-Myers expects Waltham site to close in early 2018
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09:32 EDTBMYBristol-Myers opens research site in Cambridge, discontinues virology research
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June 24, 2015
13:23 EDTPFEPfizer says CDC committee votes to recommend MenB vaccine
Pfizer announced that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend that decisions to vaccinate adolescents and young adults 16 through 23 years of age against serogroup B meningococcal disease should be made at the individual level with healthcare providers. It added, "Specifically, the ACIP voted that a serogroup B meningococcal vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age." Pfizer's Trumenba is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. The ACIP recommendation will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval, Pfizer said.
11:02 EDTPFEPfizer lung cancer treatment granted FDA orphan drug designation
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09:07 EDTPFECAR-T cancer drug researchers seen as M&A targets, Bloomberg says
Juno Therapeutics (JUNO), Kite Pharma (KITE) and Bluebird Bio (BLUE) are trading well above their IPO levels as takeovers predictions have spurred interest and share increases for the developers of CAR-T gene therapies, said Bloomberg's "Real M&A" column, quoting Dimo Dimov, a professor at the University of Bath’s School of Management, as having said that companies such as Pfizer (PFE), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are "closely watching" the firms. Cellectis (CLLS), which is working with Pfizer on its own approach to CAR-T therapy, has said it wants to bring its therapy to market and doesn’t anticipate a sale, the report noted. Reference Link
07:29 EDTBMYFDAnews to hold a summit
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June 23, 2015
14:17 EDTPFEGlycoMimetics to receive $20M payment from Pfizer
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14:01 EDTPFEPfizer announces enrollment of first patient in RESET study
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09:53 EDTPFEPfizer management to meet with FBN Securities
Meeting to be held in New York on June 25 hosted by FBN Securities.
07:25 EDTPFEPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.

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