Pharmacyclics

Pharmacyclics launches informCLL registry for CLL patients

Friday, December 5, 2014

Pharmacyclics, a Sunnyvale, Calif.-based biopharmaceutical company, has launched informCLL, a large, observational, prospective registry that will explore the natural history of chronic lymphocytic leukemia (CLL), examine how Imbruvica (ibrutinib) and other approved targeted therapies are being used to treat patients with CLL and provide a comparison to treatments using conventional chemoimmunotherapy (CIT). Imbruvica is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, and the registry is a joint effort between the companies. Registry enrollment will begin in the first half of 2015.

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AstraZeneca, Pharmacyclics, Janssen partner

Wednesday, November 5, 2014

AstraZenecaPharmacyclics and Janssen R&D have entered into a clinical trial collaboration to evaluate the efficacy and safety of AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with imbruvica (ibrutinib), an oral Bruton’s tyrosine kinase inhibitor, co-developed and co-commercialized by Pharmacyclics and Janssen Biotech. The study will assess the combination as a treatment for patients with hematologic cancers including diffuse large B-cell lymphoma and follicular lymphoma, which are investigational uses for both compounds.

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Bristol-Myers Squibb, Pharmacyclics and Janssen collaborate

Wednesday, October 15, 2014

Bristol-Myers SquibbPharmacyclics and Janssen R&D have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of BMS’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in combination with Imbruvica (ibrutinib), an oral Bruton’s tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen.

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FDA expands approved use of Imbruvica for CLL

Thursday, July 31, 2014

The FDA has expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a Breakthrough Therapy Designation for this use.

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Pharmacyclics files sNDa for IMBRUVICA

Friday, April 11, 2014

Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the FDA, based on data from the randomized, multi-center, open-label phase III RESONATE study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICA (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.

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Pharmacyclics, Catalent partner

Monday, November 25, 2013

Catalent Pharma Solutions, a provider of development solutions and advanced delivery technologies for drug, biologic and consumer health products, has signed an agreement with Pharmacyclics for the oncology drug IMBRUVICA (Ibrutinib). This follows a successful multiple-year development and clinical manufacturing partnership that aided Pharmacyclics’ expedited NDA submission and approval by the FDA.

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