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[{"orgOrder":0,"company":"Kashiv Specialty Pharmaceuticals","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"D","amount":"$108.0 million","upfrontCash":"Undisclosed","newsHeadline":"Amneal to Acquire Substantially all of Kashiv Specialty Pharmaceuticals","therapeuticArea":"Neurology","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Kashiv Specialty Pharmaceuticals","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Amneal Completes Acquisition of Kashiv Specialty Pharmaceuticals","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amneal Enters U.S. Biosimilars Market With Approval of RELEUKOTM (filgrastim-ayow)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA\u2122 (pegfilgrastim-pbbk)","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Brand Institute","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brand Institute Partners on Brand Name Development for FDA Approved Treatment for Febrile Neutropenia in Cancer Patients","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kashiv Biosciences Achieves Second U.S. Biosimilar Approval with FYLNETRA\u00ae (pegfilgrastim-pbbk)","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amneal Launches Third Biosimilar with FYLNETRA\u2122 (pegfilgrastim-pbbk) in the United States","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2023","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kashiv Biosciences Announces Successful Phase 1 Study Results of ADL018, A Biosimilar Candidate to Xolair (omalizumab)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kashiv BioSciences Enrolls First Patient in Phase III Clinical Study for ADL018, A Biosimilar Candidate to XOLAIR\u00ae (omalizumab)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Alvotech","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Alvotech Enters into Exclusive Licensing Agreement with Kashiv BioSciences for Development and Commercialization of a Proposed Biosimilar to Xolair\u00ae (omalizumab)","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"}]

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            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.

            Lead Product(s): Omalizumab

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AVT23

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Alvotech

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement October 03, 2023

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            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 urticaria.

            Lead Product(s): Omalizumab

            Therapeutic Area: Immunology Product Name: ADL018

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 02, 2023

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            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 urticaria.

            Lead Product(s): Omalizumab

            Therapeutic Area: Immunology Product Name: ADL018

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 05, 2023

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            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 febrile neutropenia.

            Lead Product(s): Pegfilgrastim-pbbk

            Therapeutic Area: Hematology Product Name: Fylnetra

            Highest Development Status: Approved Product Type: Large molecule

            Recipient: Amneal Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 16, 2023

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            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 of febrile neutropenia.

            Lead Product(s): Pegfilgrastim

            Therapeutic Area: Hematology Product Name: Fylnetra

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Brand Institute

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 21, 2022

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            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.

            Lead Product(s): Pegfilgrastim

            Therapeutic Area: Hematology Product Name: Fylnetra

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Amneal Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 31, 2022

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            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.

            Lead Product(s): Pegfilgrastim

            Therapeutic Area: Hematology Product Name: Fylnetra

            Highest Development Status: Approved Product Type: Large molecule

            Recipient: Amneal Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 27, 2022

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            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.

            Lead Product(s): Filgrastim

            Therapeutic Area: Oncology Product Name: Releuko

            Highest Development Status: Approved Product Type: Large molecule

            Recipient: Amneal Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 01, 2022

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            Amneal Pharmaceuticals has completed its previously announced acquisition of a 98% interest in Kashiv Specialty Pharmaceuticals, a wholly-owned subsidiary of Kashiv focused on the development of complex generics, innovative drug delivery platforms and novel 505(b)(2) drugs.

            Lead Product(s): Filgrastim

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Amneal Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition April 05, 2021

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            The acquisition enhances Amneal's R&D expertise with the addition of the Kashiv Specialty team and its impressive track record in developing complex generic products (e.g. Yuvafem and EluRyng) and innovative drug delivery technologies.

            Lead Product(s): K102

            Therapeutic Area: Neurology Product Name: K102

            Highest Development Status: Undisclosed Product Type: Small molecule

            Partner/Sponsor/Collaborator: Amneal Pharmaceuticals

            Deal Size: $108.0 million Upfront Cash: Undisclosed

            Deal Type: Acquisition January 12, 2021

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