Kashiv BioSciences Enrolls First Patient in Phase III Clinical Study for ADL018, A Biosimilar Candidate to XOLAIR® (omalizumab)
Kashiv BioSciences's Biologic Releuko (Filgrastim) Receives Approval in the U.S.
PISCATAWAY, N.J.--(BUSINESS WIRE)--Kashiv Biosciences, LLC (“Kashiv” or the “Company”) today announced that ADL018, a biosimilar candidate to Xolair® (omalizumab), completed a successful global Phase 1 clinical study in healthy volunteers.
Kashiv's Biologic Releuko (Filgrastim) Receives Approval in the U.S.
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Kashiv Biosciences, LLC (“Kashiv” or the “Company”) is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has approved its Biologics License Application (“BLA”) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta®. The product will be marketed under the proprietary name FYLNETRA®.
Kashiv Biosciences' Flunetra (Pegfilgrastim-pbbk)) Receives Approval in the U.S.
PISCATAWAY, N.J.--(BUSINESS WIRE)--Kashiv Biosciences, LLC (“Kashiv”) today announced the U.S. Food and Drug Administration (FDA) approval of its Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen. The product will be marketed under the proprietary name RELEUKO.
Kashiv Biosciences' Biologic Releuko (Filgrastim) Receives Approval in the U.S.
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (the “Company”) (NYSE: AMRX) and Kashiv BioSciences LLC (“Kashiv”) today announced that Amneal Pharmaceuticals LLC (“Amneal”), a subsidiary of the Company, has completed its previously announced acquisition of a 98% interest in Kashiv Specialty Pharmaceuticals, LLC (“Kashiv Specialty”), a wholly-owned subsidiary of Kashiv focused on the development of complex generics, innovative drug delivery platforms and novel 505(b)(2) drugs.