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Last updated on April 19, 2014 at 13:20 EDT

Latest Ofatumumab Stories

2014-04-17 16:27:38

LONDON, April 17, 2014 /PRNewswire/ -- GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra(®) (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered...

2014-04-08 08:31:42

New submission based on positive Phase 3 data from the RESONATE(TM) trial RARITAN, N.J., April 8, 2014 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA(TM) (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. This regulatory submission is based on data from the Phase 3 RESONATE(TM) study in relapsed or refractory chronic...

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...

2014-03-27 12:30:38

DUBLIN, Mar. 27, 2014 /PRNewswire/ -- Research and Markets ( http://www.researchandmarkets.com/research/rwdz5w/therapy_class ) has announced the addition of the "Therapy Class Overview: Rituximab biosimilar" report to their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769) Approval of Inflectra/Remsima, the first biosimilar Monoclonal antibody (Mab) from Celltrion and Hospira in EU in 2013 is a trend setter! Inflectra is a biosimilar of Johnson & Johnson's Remicade,...

2014-02-20 16:25:31

Company launches its first product, IMBRUVICA(TM), and records net product revenue of $13.6 million SUNNYVALE, Calif., Feb. 20, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) today reported financial results and recent developments for the quarter and year ended December 31, 2013. Financial Results for the Quarter and Year Ended December 31, 2013 Revenue Total revenue for the quarter ended December 31, 2013 increased 113% to $123.6 million, from $58.0 million for the...

2014-02-12 16:26:29

CLL is second indication approved by FDA for ibrutinib; previously approved for mantle cell lymphoma patients WHITE PLAINS, N.Y., Feb. 12, 2014 /PRNewswire/ -- Today's U.S. Food and Drug Administration (FDA) approval of ibrutinib to treat patients with chronic lymphocytic leukemia (CLL) is a significant advance for patients with this blood cancer. Ibrutinib received FDA approval in November to treat patients with mantle cell lymphoma (MCL) who had previously been treated with one...

2014-01-07 12:27:02

RARITAN, N.J., Jan. 7, 2014 /PRNewswire/ -- Janssen Research & Development, LLC today announced the early stopping of PCYC-1112-CA, the Phase 3 study of IMBRUVICA(TM) (ibrutinib) in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), based on the recommendation of an Independent Data Monitoring Committee (IDMC), which concluded that the study showed a significant difference in progression-free survival (PFS) as compared to the control, the...

2014-01-07 12:26:56

SUNNYVALE, Calif., Jan. 7, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that an Independent Data Monitoring Committee (IDMC) unanimously recommended that the Phase III RESONATE study, PCYC-1112-CA, a head-to-head comparison of IMBRUVICA(TM) (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...

2013-11-07 16:32:03

SUNNYVALE, Calif., Nov. 7, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) today reported financial results and recent developments for the quarter ended September 30, 2013. Financial Results for the Three and Nine Months Ended September 30, 2013 Revenue for the quarter ended September 30, 2013 was $79.1 million compared to $54.7 million for the quarter ended June 30, 2013 and $102.7 million for the quarter ended September 30, 2012. Included in revenue for the three...

2013-11-04 16:28:32

WHITE PLAINS, N.Y., Nov. 4, 2013 /PRNewswire/ -- The U.S. Food and Drug Administration's approval of Gazyva® (obinutuzumab) is an important advance for patients diagnosed with chronic lymphocytic leukemia (CLL). Gazyva, the first treatment approved through the FDA's breakthrough therapy designation, is indicated in combination with chlorambucil to treat previously untreated patients with CLL. Breakthrough therapy designation is granted if preliminary clinical evidence indicates the...