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June 1, 2014
18:46 EDTPCYC, JNJImbruvica combination with anti CD20 antibody shows 'compelling' results
Pharmacyclics (PCYC) announced 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 this study was not reached. The results from this study will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology,ASCO. This release corresponds to abstract 7009. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ).
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June 17, 2015
07:21 EDTJNJGeneric ADHD drugs still sold despite FDA non-equivalance finding, NYT reports
The FDA announced last November that two generic versions of Johnson & Johnson's (JNJ) Concerta ADHD drug, one made by Mallinckrodt (MNK) and the other by UCB, could no longer be considered the equivalent of the branded drug after tests and analyses suggested that their effectiveness began to wear off much more quickly, but the drugs are still being sold despite an FDA mandated deadline having passed for the companies to either prove the drugs were equivalent or remove them from the market, said The New York Times. The report noted a third generic product, sold by Actavis (AGN), was found to be equivalent to the branded Concerta. Reference Link

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