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Latest Ofatumumab Stories

2014-07-31 16:28:44

- IMBRUVICA Net Product Revenue Increased to $109.5 million for the Second Quarter of 2014 - SUNNYVALE, Calif., July 31, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) today reported financial results and recent developments for the quarter ended June 30, 2014. Financial Results for the Six Months and Quarter Ended June 30, 2014 Revenue Total revenue for the quarter ended June 30, 2014 increased to $113.0 million from $54.7 million for the quarter ended June 30,...

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...

2014-07-25 08:26:13

SUNNYVALE, Calif., July 25, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the granting of full marketing approval for IMBRUVICA(®) (ibrutinib) in the European Union. IMBRUVICA is being jointly developed and commercialized in the United States by Pharmacyclics and Janssen Biotech, Inc. In Europe, once approved,...

2014-07-23 16:28:25

WHITE PLAINS, N.Y., July 23, 2014 /PRNewswire-USNewswire/ -- Today's U.S. Food and Drug Administration (FDA) approval of idelalisib to treat patients with relapsed chronic lymphocytic leukemia (CLL), follicular lymphoma (FL) and small lymphocytic lymphoma (SLL) is a significant advance for patients with these blood cancers. Idelalisib, which goes by the trade name Zydelig®, is a first-in-class inhibitor of PI3K delta, a protein that is highly expressed in many B-cell malignancies...

2014-07-09 16:25:02

LONDON, July 9, 2014 /PRNewswire/ -- Reportbuyer.com has added a new market research report: OpportunityAnalyzer: Chronic Lymphocytic Leukemia - Opportunity Analysis and Forecasts to 2018 https://www.reportbuyer.com/product/2225869/OpportunityAnalyzer-Chronic-Lymphocytic-Leukemia---Opportunity-Analysis-and-Forecasts-to-2018.html OpportunityAnalyzer: Chronic Lymphocytic Leukemia - Opportunity Analysis and Forecasts to 2018 SummaryChronic lymphocytic leukemia (CLL), the most common...

2014-06-09 08:29:03

SUNNYVALE, Calif., June 9, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval. The sNDA was submitted to the FDA based on data from the...

2014-06-05 23:03:26

In-demand research report “Chronic Lymphocytic Leukaemia: KOL Insight” worked out by FirstWord is now available at MarketPublishers.com. London, UK (PRWEB) June 05, 2014 Chronic lymphocytic leukaemia (CLL) is the most common type of the leukaemias. Nevertheless, until recently, it has been underserved in terms of effective therapeutic options. However, a revolution in targeted and personalized therapies is tremendously altering the treatment algorithm and also spurs the development of...

2014-06-03 11:18:46

Ohio State University Wexner Medical Center In a head-to-head comparison of two Food and Drug Administration-approved drugs for the treatment of relapsed chronic lymphocytic leukemia (CLL), ibrutinib significantly outperformed ofatumumab as a second-line therapy, according to a multicenter interim study published in the OnLine First edition of the New England Journal of Medicine. Ibrutinib (Imbruvica) is the first drug designed to target Bruton's tyrosine kinase (BTK), a protein essential...

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...


Word of the Day
omadhaun
  • A fool; a simpleton: a term of abuse common in Ireland and to a less extent in the Gaelic-speaking parts of Scotland.
This word is partly Irish in origin.