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Recent Articles

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FDA grants Breakthrough Therapy Designation for Janssen’s talquetamab injectable antibody to treat relapsed or refractory multiple myeloma, a cancer of plasma cells; multiple myeloma affects 34,000 people in US annually, 176,000 worldwide

FDA grants breakthrough therapy designation to Sanofi’s efanesoctocog alfa BIVV001 injectable to treat hemophilia A, a life-threatening bleeding disorder; hemophilia A is a lifelong condition that affects about one in 5,000 males, fewer females

Pfizer partners with MorphoSys, Incyte to evaluate combined therapy to treat diffuse large B-cell lymphoma, a type of blood cancer; drugs include Pfizer’s experimental TTI-622, Morphosys and Incyte’s Monjuvi tafasitamab-cxix, Revlimid lenalidomide

Charles River Laboratories partners with ASC Therapeutics to manufacture ASC618, a second-generation injectable gene therapy for hemophilia A; partnership will use Charles River’s end-to-end CDMO capabilities

Amgen and Kashiv Biosciences get US approval for Fylnetra, a biosimilar to Amgen’s injectable Neulasta pegfilgrastim to treat neutropenia resulting from chemotherapy; in 12 months ending March 2022, Neulasta biosimilars had US sales of US$1B

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