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January 7, 2014
09:34 EDTJNJ, PCYCPharmacyclics 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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December 1, 2015
09:34 EDTJNJBarclays biopharmaceuticals analysts hold analyst/industry conference call
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07:46 EDTJNJFDA and the Parental Drug Association to co-host a conference
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05:45 EDTJNJJohnson & Johnson upgraded to Overweight from Equal Weight at Barclays
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05:43 EDTJNJEli Lilly assumed with an Overweight from Equal Weight at Barclays
Barclays analyst Geoff Meacham upgraded Eli Lilly (LLY) to Overweight after assuming coverage of the name. Good execution for Cyramza and Jardiance should drive continued share outperformance, Meacham tells investors in a research note. He raised his price target for shares to $95 from $75. Lilly closed yesterday down $1.43 to $82.22. The analyst this morning also upgraded Johnson & Johnson (JNJ) and Merck (MRK) to Overweight and downgraded AbbVie (ABBV) to Equal Weight.
November 30, 2015
10:26 EDTJNJFDA approves Empliciti to treat multiple myeloma
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November 20, 2015
10:52 EDTJNJFDA approves new oral medication to treat multiple myeloma
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November 18, 2015
08:11 EDTJNJIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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08:11 EDTJNJAduro Biotech receives milestone payment from Janssen
Aduro Biotech (ADRO) announced that it has received a milestone payment from Janssen Biotech (JNJ) for Aduro's submission of an Investigational New Drug, or IND, Application to the FDA for ADU-741, a LADD immunotherapy product candidate for the treatment of prostate cancer. The IND will enable Janssen, Aduro's license partner for ADU-741, to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-741 in patients with metastatic castration-resistant prostate cancer.

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