DIA Biosimilars 2013

Pharmacyclics

Pharmacyclics submits NDA for Ibrutinib

Tuesday, July 16, 2013 11:36 AM

Pharmacyclics, a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases, based in Sunnyvale, Calif., has submitted a New Drug Application (NDA) to the FDA for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

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Cenduit: Now with Patient Reminders

Abbott, Janssen, Pharmacyclics to develop companion test for leukemia therapy

Friday, February 22, 2013 11:16 AM

Global healthcare company Abbott has formed a collaboration with Janssen Biotech and Pharmacyclics, a biopharmaceutical company based in Sunnyvale, Calif., to explore the benefits of Abbott's proprietary FISH (fluorescence in situ hybridization) technology for use in developing a molecular companion diagnostic test to identify patients with a genetic subtype of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia.

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CRF Health – eCOA Forum

Pharmacyclics triggers $50M milestone payment for mantle cell lymphoma trial

Monday, August 20, 2012 11:35 AM

Pharmacyclics, a clinical-stage biopharmaceutical company of Sunnyvale, Calif., announced that the clinical trial, SPARK, of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL) has enrolled its fifth patient, triggering a second $50 million milestone payment obligation from Janssen Biotech.

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Janssen, Pharmacyclics collaborate to develop anti-cancer drug

Friday, December 9, 2011 07:56 AM

Janssen Biotech, one of the Janssen Pharmaceutical companies of Johnson & Johnson, has executed an agreement with Pharmacyclics to jointly develop and market the anti-cancer compound, PCI-32765. A number of phase I and II studies with PCI-32765 are ongoing across a panel of B-cell malignancy disorders, including chronic lymphocytic leukemia, mantle cell lymphoma, and diffuse large B-cell lymphoma.

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Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

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New growth and decline in Asia clinical trials
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Harnessing Big Data to transform clinical trials
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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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