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News Breaks
January 7, 2014
09:34 EDTPCYC, JNJPharmacyclics says Phase III ibrutinib study meets primary endpoint
Pharmacyclics announced that an Independent Data Monitoring Committee unanimously recommended that the Phase III RESONATE study, PCYC-1112-CA, a head-to-head comparison of IMBRUVICATM, ibrutinib, versus ofatumumab, be stopped early because the primary and a key secondary endpoint of the study have been met. At the planned interim analysis, the Phase III RESONATE study demonstrated that IMBRUVICA showed a statistically significant improvement in progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Further, IMBRUVICA showed statistically significant improvement in overall survival, a key secondary endpoint of the trial. The safety profile of IMBRUVICA was acceptable and consistent with prior clinical experience. The IDMC recommended that the sponsor provide access to IMBRUVICA for subjects on the ofatumumab arm. Pharmacyclics has informed the U.S. Food and Drug Administration of the recommendations of the IDMC. Similarily, Janssen (JNJ), the co-developer of IMBRUVICA, has informed the European Medicines Agency. Both companies are engaging in a dialogue with the Health Authorities to define the next regulatory steps and anticipate providing a comprehensive RESONATE study report to them within the coming months. The company anticipates that the detailed data analysis from this RESONATE Phase III study will be presented at an upcoming oncology conference.
News For PCYC;JNJ From The Last 14 Days
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August 27, 2015
19:49 EDTJNJJohnson & Johnson to open shared services headquarters in Florida
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August 25, 2015
13:01 EDTJNJJ&J unit to sell Splenda brand to Heartland Food, terms not disclosed
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09:03 EDTJNJAcorda has major overhang removed by IPR denials, says Leerink
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06:18 EDTJNJSears names Lynn Pendergrass as Hardlines president
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August 21, 2015
09:01 EDTJNJLeerink medical devices analyst holds an analyst/industry conference call
Medical Device Analyst Newitter, along with MEDACorp Specialists Dorance Dillon and Terence Farrell, discuss the Centers for Medicare & Medicaid Services' recently proposed "Comprehensive Care For Joint Replacement Payment Model" and how this model might influence ortho pricing and hospital-vendor relationships on an Analyst/Industry conference call to be held on August 24 at 1 pm.
August 20, 2015
11:33 EDTJNJLeerink major pharmaceuticals analyst holds an analyst/industry conference call
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