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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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April 15, 2014
16:22 EDTJNJOn The Fly: Closing Wrap
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12:58 EDTJNJOn The Fly: Midday Wrap
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10:23 EDTJNJOptions with decreasing implied volatility: FDO JNJ FAST EPB
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09:16 EDTJNJOn The Fly: Pre-market Movers
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09:11 EDTJNJJohnson & Johnson says has implemented some cost reductions in MD&D sector
Says has implemented some cost reductions, combined some businesses in the Medical Devices & Diagnostics sector to better compete in the current marketplace.
08:56 EDTJNJJohnson & Johnson sees FY net interest expense $400M-$500M
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08:19 EDTJNJJohnson & Johnson sees deal to sell K-Y brand to Reckitt closing mid-year
Sees sees deal to sell K-Y brand to Reckitt Benckiser (RBGPF) closing mid-year. Says offer from Carlyle Group (CG) to acquire Ortho-Clinical Diagnostics expected to close mid-year. Comments from slides that will be presented on the Q1 earnings conference call.
07:49 EDTJNJJohnson & Johnson reports Q1 Domestic sales up 2.2%; Intl sales up 4.5%
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07:47 EDTJNJJohnson & Johnson raises FY14 EPS to $5.80-$5.90, consensus $5.83
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07:46 EDTJNJJohnson & Johnson reports Q1 adjusted EPS $1.54, consensus $1.48
Reports Q1 revenue $18.1B, consensus $18.0B
06:32 EDTJNJPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
15:17 EDTJNJNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Johnson & Johnson (JNJ), consensus $1.48; Coca-Cola (KO), consensus 44c; Charles Schwab (SCHW), consensus 22c; Northern Trust (NTRS), consensus 78c; Comerica (CMA), consensus 72c; Westamerica (WABC), consensus 58c; Comverse (CNSI), consensus 49c; Pep Boys (PBY), consensus 5c.
13:25 EDTJNJEarnings Preview: J&J looking for another strong performance in pharmaceuticals
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10:02 EDTJNJOn The Fly: Analyst Downgrade Summary
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05:56 EDTJNJJohnson & Johnson downgraded to Hold from Buy at Jefferies
Jefferies downgraded its rating on Johnson & Johnson (JNJ) to Hold citing the recent outperformance of shares. The firm keeps a $105 price target for the stock.
April 11, 2014
18:44 EDTJNJJ&J halting development of Botox competitor, WSJ says
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April 9, 2014
07:23 EDTJNJEuropean Association for the Study of the Liver to hold annual meeting
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07:09 EDTJNJJohnson & Johnson outlook positive into Q1 results, says Bernstein
Bernstein expects Johnson & Johnson's Q1 EPS to come in slightly above the consensus estimate, with strength in pharmaceuticals more than offsetting lackluster Medical Devices & Diagnostics growth, according to the firm. Bernstein keeps an Outperform rating on the stock.
April 8, 2014
08:05 EDTPCYCPharmacyclics files supplemental new drug application for Imbruvica
Pharmacyclics announced that it has submitted a supplemental New Drug Application to the FDA, based on data from the randomized, multi-center, open-label Phase III Resonatetm study, PCYC-1112, a head-to-head comparison of single agent Imbruvicatm versus ofatumumab in 391 patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.
07:26 EDTJNJElsevier Business Intelligence to hold a conference
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