Kashiv BioSciences, LLC

5 articles about Kashiv BioSciences, LLC

• Kashiv Biosciences Achieves Second U.S. Biosimilar Approval with FYLNETRA® (pegfilgrastim-pbbk)

  5/31/2022

  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®.

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  Biosimilars Gain Headway in US with Approval of Kashiv’s Releuko

  3/11/2022

  Releuko is expected to launch in the third quarter of 2022 as a treatment for neutropenia, a low white blood cell condition experienced by chemotherapy patients. 

• Kashiv Biosciences Receives Approval for Its First Biosimilar RELEUKOTM (filgrastim-ayow)

  3/2/2022

  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®.

• Amneal to Acquire Substantially All of Kashiv Specialty Pharmaceuticals

  1/12/2021

  Amneal Pharmaceuticals, Inc. and Kashiv BioSciences LLC announced they have entered into a definitive agreement under which Amneal Pharmaceuticals LLC, a wholly-owned subsidiary of the Company, will acquire a 98% interest in Kashiv Specialty Pharmaceuticals, LLC, a wholly-owned subsidiary of Kashiv focused on the development of complex generics, innovative drug delivery platforms and novel 505 drugs.

• Amneal Enters into a Licensing Agreement with Kashiv BioSciences, LLC to Develop and Commercialize K127 for the Treatment of Myasthenia Gravis

  11/6/2019

  Expands Amneal’s Central Nervous System (CNS) Focused Development Pipeline with Orphan Drug