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Janssen gets CHMP positive opinion for expanded use of IMBRUVICA, rituximab combo in CLL
pharmaceutical-business-review
July 29, 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for IMBRUVICA ...
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FDA Approves IMBRUVICA, Rituximab Combination for Chronic Lymphocytic Leukemia
americanpharmaceuticalreview
April 24, 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with rituximab for ...
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FDA approves IMBRUVICA® (ibrutinib) for treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma
europeanpharmaceuticalreview
April 23, 2020
IMBRUVICA (ibrutinib), in combination with rituximab, has been given approval in the US for the treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma.
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Imbruvica® granted expanded use from European Commission
europeanpharmaceuticalreview
August 15, 2019
The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström’s macroglobulinemia.
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Imbruvica receives positive opinion from CHMP
pharmaceutical-technology
July 03, 2019
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the existing marketing authorisation (MA) for Janssen’s Imbruvica (ibrutinib) to include chronic lymphocytic leukaemia (CLL) and Waldenst
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AbbVie and J&J’s Imbruvica fails pancreatic cancer test
pharmaphorum
January 23, 2019
AbbVie and Johnson & Johnson’s hopes of adding pancreatic cancer to the repertoire of oncology blockbuster Imbruvica has hit a snag.
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China’s BeiGene delays US filing for rival to Imbruvica
pharmaphorum
December 05, 2018
BeiGene’s plans for an early approval for BTK inhibitor zanubrutinib in the US and to start challenging Janssen/AbbVie’s blockbuster Imbruvica have suffered a setback.
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FDA Approves Imbruvica Plus Rituximab
americanpharmaceuticalreview
August 28, 2018
Janssen Pharmaceutical announced the U.S. Food and Drug Administration (FDA) approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM), a rare blood cancer.
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As Humira competition nears, AbbVie's Imbruvica and Mavyret pick up steam
fiercepharma
July 30, 2018
Even as AbbVie's megablockbuster immunology med Humira inches toward its first biosim competition, the drug is still churning out record sales.
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AbbVie, J&J’s Imbruvica fails to target in B-Cell lymphoma trial
pharmatimes
July 13, 2018
AbbVie and Johnson & Johnson’s Imbruvica has failed to meet its key target in a late stage study assessing its use in patients with treatment-naïve diffuse large B-cell lymphoma.