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Latest Janssen Biotech Inc. Stories

2014-07-28 12:28:51

Approval based on Phase 3 RESONATE data with statistically significant improvements in progression-free and overall survival HORSHAM, Pa., July 28, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for IMBRUVICA(®) (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.[1] The FDA also approved IMBRUVICA for CLL patients with del...

2014-07-28 12:28:45

Previously Treated Chronic Lymphocytic Leukemia (CLL) Based on Statistically Significant Progression-Free and Overall Survival Benefits SUNNYVALE, Calif., July 28, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that the U.S. Food and Drug Administration (FDA) has granted IMBRUVICA(®) (ibrutinib) regular (full) approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL...

2014-06-24 08:30:32

CAMBRIDGE, Mass., June 24, 2014 /PRNewswire/ -- Johnson & Johnson Innovation, Boston and Janssen Biotech, Inc. today announced a three-year immuno-oncology lung cancer collaboration with the Dana-Farber Cancer Institute. Through the collaboration, Janssen scientists will work with the research team at Dana-Farber's Belfer Institute for Applied Cancer Science to determine the clinical setting for certain immuno-oncology agents in Janssen's lung cancer discovery pipeline. "We are...

2014-06-02 08:30:44

Phase 2 study data presented at the 50th annual meeting of the American Society of Clinical Oncology HORSHAM, Pa., June 2, 2014 /PRNewswire/ -- Abiraterone acetate (ZYTIGA(®)) plus prednisone demonstrated statistically significant reductions in PSA levels at six months, the primary endpoint of the IMAAGEN trial, which evaluates the investigational use of abiraterone acetate plus prednisone (5 mg once daily) in patients with non-metastatic castration-resistant prostate cancer...

2014-05-31 08:21:36

SUNNYVALE, Calif., May 31, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) announced today that IMBRUVICA®(ibrutinib) in combination with the anti-CD20 antibody, ofatumumab, showed a Kaplan Meier estimate of continued clinical response at 18 months of 82.5% in heavily pre-treated patients with chronic lymphoma leukemia (CLL), small lymphocytic leukemia (SLL), prolymphocytic leukemia (PLL) and Richters Transformation (RT). The median duration of response for all dosing schedules in...

2014-05-31 08:21:30

SUNNYVALE, Calif., May 31, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) announced today that IMBRUVICA®( )(ibrutinib) will be featured in an oral presentation highlighting long-term responses to treatment, with up to three years of follow up in 132 patients with treatment naive or relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The results from this study will be presented at the 50(th) Annual Meeting of the American Society of...

2014-05-31 08:21:22

Results from Phase III RESONATE(TM) Trial Published in an Online First Edition of the New England Journal of Medicine SUNNYVALE, Calif., May 31, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced trial results of the first Phase III study (RESONATE, PCYC-1112-CA), a head-to-head comparison of IMBRUVICA® (ibrutinib) versus ofatumumab in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Patients receiving IMBRUVICA...

2014-04-23 16:31:29

First treatment approved for patients with rare blood disorder HORSHAM, Pa., April 23, 2014 /PRNewswire/ -- Janssen Biotech, Inc. ["Janssen"] today announced the U.S. Food and Drug Administration (FDA) has approved SYLVANT(TM) (siltuximab) for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8...

2014-04-21 12:27:29

SUNNYVALE, Calif., April 21, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that data from the Phase III PCYC-1112 (RESONATE(TM)) study of single agent IMBRUVICA(TM) (ibrutinib) vs. ofatumumab, an established therapy in relapsed refractory CLL, as well as data from an Independent Efficacy Evaluation of IMBRUVICA after three years of follow-up, will be presented at the American Society of Clinical Oncology (ASCO) 50th Annual Meeting in Chicago, Illinois May 30 - June...

2014-04-08 08:31:34

SUNNYVALE, Calif., April 8, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multi-center, open-label Phase III RESONATE(TM) study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICA(TM) (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who...


Word of the Day
lambent
  • Licking.
  • Hence Running along or over a surface, as if in the act of licking; flowing over or along; lapping or bathing; softly bright; gleaming.
This word comes the Latin 'lambere,' to lick.
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