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Bispecific antibodies will mature after 2021, $6bn estimated sales in oncology by 2025: GlobalData
expresspharma
October 09, 2020
There are 106 bispecific antibody molecules in the pipeline and 263 ongoing/planning to enrol clinical trials involving a bispecific antibody.
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Amgen announces positive results from two Phase 3 BLINCYTO® (blinatumomab) studies In pediatric patients with relapsed acute lymphoblastic leukemia
worldpharmanews
September 26, 2019
Amgen announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (20120215) showed that the primary endpoint of event-free survival was met.
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NICE nod for Blincyto
pharmatimes
June 19, 2019
The National Institute for Health and Care Excellence (NICE) has announced the recommendation of Amgen’s Blincyto (blinatumomab) for treating acute lymphoblastic leukaemia (ALL). The indication is for patients in first complete remission with minimal resi
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Amgen’s Blincyto gets expanded indication for B-cell ALL in Europe
pharmaceutical-technology
January 24, 2019
The European Commission (EC) has granted approval for the use of Amgen’s Blincyto as a monotherapy to treat adults with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL)....
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Amgen Receives CHMP Positive Opinion to Expand Use of Blincyto
americanpharmaceuticalreview
November 20, 2018
Amgen announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has ado
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Blincyto Approved In Japan
americanpharmaceuticalreview
September 27, 2018
Amgen announced the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Blincyto (blinatumomab) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Blincyto was developed in Japan by Amgen
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Amgen’s Blincyto gets EU approval for relapsed B cell precursor ALL
pharmaceutical-technology
September 04, 2018
On June 19, Amgen announced that the European Commission (EC) has granted full approval for the bispecific antibody drug, Blincyto (blinatumomab), for patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymph
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European Commission Approves Expanded Indication Blincyto
americanpharmaceuticalreview
August 30, 2018
Amgen announced the European Commission (EC) has approved an expanded indication for Blincyto (blinatumomab) as monotherapy for the treatment of pediatric patients aged one year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor
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Amgen’s Blincyto gets full EU approval for rare leukaemia
pharmatimes
June 21, 2018
European regulators have awarded Amgen’s Blincyto full approval for Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow thought to aff
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FDA expands approval of Blincyto for treatment of B-cell precursor ALL
europeanpharmaceuticalreview
April 09, 2018
The FDA has granted accelerated approval to Blincyto to treat adults and children with B-cell precursor acute lymphoblastic leukaemia (ALL)…