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    [{"orgOrder":0,"company":"Kashiv Specialty Pharmaceuticals","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"D","therapeuticArea":"Neurology","country":"","productType":"Small molecule","year":"2021","type":"Acquisition","leadProduct":"K102","moa":"","graph1":"Neurology","graph2":"Undisclosed","graph3":"Kashiv Specialty Pharmaceuticals","amount2":0.11,"highestDevelopmentShortName":"Undisclosed","therapeuticAreaShortName":"Neurology","amount2New":0.11,"dosageForm":"","sponsorNew":"Kashiv Specialty Pharmaceuticals \/ Amneal","highestDevelopmentStatusID":"1","companyTruncated":"Kashiv Specialty Pharmaceuticals \/ Amneal"},{"orgOrder":0,"company":"Kashiv Specialty Pharmaceuticals","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"","productType":"Large molecule","year":"2021","type":"Acquisition","leadProduct":"Filgrastim","moa":"GCSF","graph1":"Oncology","graph2":"Phase III","graph3":"Kashiv Specialty 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\/ Amneal Pharmaceuticals","highestDevelopmentStatusID":"10","companyTruncated":"Kashiv BioSciences \/ Amneal Pharmaceuticals"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Immunology","country":"","productType":"Large molecule","year":"2024","type":"Not Applicable","leadProduct":"Omalizumab","moa":"","graph1":"Technology","graph2":"Phase I\/II","graph3":"Kashiv BioSciences","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Technology","amount2New":0.94999999999999996,"dosageForm":"","sponsorNew":"Kashiv BioSciences \/ Not Applicable","highestDevelopmentStatusID":"14","companyTruncated":"Kashiv BioSciences \/ Not Applicable"}]

    Find Clinical Drug Pipeline Developments & Deals by Kashiv BioSciences

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                            01

                            Kashiv BioSciences

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                            2024 ACI Convention
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                            Kashiv BioSciences

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                            Lead Product(s) : Omalizumab

                            Therapeutic Area : Immunology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Kashiv BioSciences Completes Enrollment in Phase III Trial of ADL018 Biosimilar to XOLAIR®

                            Details : ADL018 (omalizumab) a biosimilar candidate to Xolair is being evaluated in late-stage clinical trial studies for the treatment of chronic idiopathic urticaria.

                            Brand Name : ADL018

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            July 25, 2024

                            Lead Product(s) : Omalizumab

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            02

                            Kashiv BioSciences

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                            2024 ACI Convention
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                            Kashiv BioSciences

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                            Lead Product(s) : Omalizumab

                            Therapeutic Area : Immunology

                            Study Phase : Phase III

                            Sponsor : Amneal Pharmaceuticals

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Kashiv BioSciences Licenses Proposed Biosimilar to XOLAIR® (Omalizumab) from Amneal

                            Details : Through the license agreement, Amneal will commercialize ADL018 (omalizumab) in the US. It is being evaluated in late-stage clinical trial studies for the treatment of chronic idiopathic urticaria.

                            Brand Name : ADL018

                            Molecule Type : Large molecule

                            Upfront Cash : Undisclosed

                            July 01, 2024

                            Lead Product(s) : Omalizumab

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase III

                            Sponsor : Amneal Pharmaceuticals

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

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                            03

                            Kashiv BioSciences

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                            2024 ACI Convention
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                            Lead Product(s) : Omalizumab

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Alvotech

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Alvotech Enters into Exclusive Licensing Agreement with Kashiv BioSciences for Development and Commercializati...

                            Details : Under the agreement, Alvotech will receive an exclusive license to commercialize AVT23 (also called ADL018), a proposed biosimilar to Xolair (omalizumab), which will be developed and manufactured by Kashiv.

                            Brand Name : AVT23

                            Molecule Type : Large molecule

                            Upfront Cash : Undisclosed

                            October 03, 2023

                            Lead Product(s) : Omalizumab

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Highest Development Status : Phase III

                            Sponsor : Alvotech

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

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                            04

                            Kashiv BioSciences

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                            2024 ACI Convention
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                            Kashiv BioSciences

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                            Lead Product(s) : Omalizumab

                            Therapeutic Area : Immunology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Kashiv BioSciences Enrolls First Patient in Phase III Clinical Study for ADL018, A Biosimilar Candidate to XOL...

                            Details : ADL018 (omalizumab) is a monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® approved to treat chronic spontaneous ...

                            Brand Name : ADL018

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            October 02, 2023

                            Lead Product(s) : Omalizumab

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            05

                            Kashiv BioSciences

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                            2024 ACI Convention
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                            Kashiv BioSciences

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                            Lead Product(s) : Omalizumab

                            Therapeutic Area : Immunology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Kashiv Biosciences Announces Successful Phase 1 Study Results of ADL018, A Biosimilar Candidate to Xolair (oma...

                            Details : ADL018 (omalizumab) is a monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® approved to treat chronic spontaneous ...

                            Brand Name : ADL018

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            July 05, 2023

                            Lead Product(s) : Omalizumab

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            06

                            Kashiv BioSciences

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                            Kashiv BioSciences

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                            Lead Product(s) : Pegfilgrastim-pbbk

                            Therapeutic Area : Hematology

                            Study Phase : Approved

                            Recipient : Amneal Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Amneal Launches Third Biosimilar with FYLNETRA™ (pegfilgrastim-pbbk) in the United States

                            Details : Fylnetra (pegfilgrastim-pbbk) is a leukocyte growth factor which decreases the incidence of infection, indicated for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of...

                            Brand Name : Fylnetra

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            May 16, 2023

                            Lead Product(s) : Pegfilgrastim-pbbk

                            Therapeutic Area : Hematology

                            Highest Development Status : Approved

                            Recipient : Amneal Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            07

                            Kashiv BioSciences

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                            Kashiv BioSciences

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                            Lead Product(s) : Pegfilgrastim

                            Therapeutic Area : Hematology

                            Study Phase : Approved

                            Sponsor : Brand Institute

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Brand Institute Partners on Brand Name Development for FDA Approved Treatment for Febrile Neutropenia in Cance...

                            Details : FYLNETRA® (pegfilgrastim-pbbk), used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence ...

                            Brand Name : Fylnetra

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            June 21, 2022

                            Lead Product(s) : Pegfilgrastim

                            Therapeutic Area : Hematology

                            Highest Development Status : Approved

                            Sponsor : Brand Institute

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            08

                            Kashiv BioSciences

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                            Lead Product(s) : Pegfilgrastim

                            Therapeutic Area : Hematology

                            Study Phase : Approved

                            Sponsor : Amneal Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

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

                            Details : FYLNETRA (Pegfilgrastim-pbbk) is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

                            Brand Name : Fylnetra

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            May 31, 2022

                            Lead Product(s) : Pegfilgrastim

                            Therapeutic Area : Hematology

                            Highest Development Status : Approved

                            Sponsor : Amneal Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            09

                            Kashiv BioSciences

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                            Lead Product(s) : Pegfilgrastim

                            Therapeutic Area : Hematology

                            Study Phase : Approved

                            Recipient : Amneal Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA™ (pegfilgrastim-pbbk)

                            Details : FYLNETRA (pegfilgrastim), is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy.

                            Brand Name : Fylnetra

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            May 27, 2022

                            Lead Product(s) : Pegfilgrastim

                            Therapeutic Area : Hematology

                            Highest Development Status : Approved

                            Recipient : Amneal Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            Kashiv BioSciences

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                            Lead Product(s) : Filgrastim

                            Therapeutic Area : Oncology

                            Study Phase : Approved

                            Recipient : Amneal Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Amneal Enters U.S. Biosimilars Market With Approval of RELEUKOTM (filgrastim-ayow)

                            Details : U.S. FDA approved biologics license application for RELEUKO (filgrastim-ayow), a biosimilar referencing Neupogen, to treat neutropenia which is commonly experienced by patients undergoing chemotherapy, acute myeloid leukemia and nonmyeloid malignancies.

                            Brand Name : Releuko

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            March 01, 2022

                            Lead Product(s) : Filgrastim

                            Therapeutic Area : Oncology

                            Highest Development Status : Approved

                            Recipient : Amneal Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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