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Press Releases

Kashiv BioSciences Enters into Exclusive Licensing Agreement with Amneal for Commercialization of a Proposed Biosimilar to XOLAIR® (Omalizumab)

Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that it has entered into an exclusive licensing agreement for ADL018 with Amneal Pharmaceuticals, Inc.

July 1, 2024

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7 min read

Press Releases

Kashiv BioSciences Appoints Dr. Sandeep Nilkanth Athalye as Global CEO

November 4, 2024

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2 min read

Drug Development

Kashiv BioSciences Enrolls First Patient in Phase III Clinical Study for ADL018, A Biosimilar Candidate to XOLAIR® (omalizumab)

Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that it has enrolled the first patient in its Phase III clinical study involving ADL018, the Company’s biosimilar candidate to XOLAIR®.

October 2, 2023

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3 min read

Pharm Country

Alvotech Enters into Exclusive Licensing Agreement with Kashiv BioSciences for Development and Commercialization of a Proposed Biosimilar to Xolair® (omalizumab)

Alvotech and Kashiv Biosciences LLC announced that they have entered into an exclusive licensing agreement for AVT23, a proposed biosimilar to Xolair®, which is currently in clinical development.

October 3, 2023

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8 min read

Business

Kashiv BioSciences Enters into Exclusive Licensing Agreement with Alvotech for Development & Commercialization of a Proposed Biosimilar to Xolair® (omalizumab)

Kashiv Biosciences LLC today announced that they have entered into an exclusive licensing agreement for ADL018 (also called AVT23), a proposed biosimilar to Xolair® (omalizumab), which is in clinical development.

October 3, 2023

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9 min read

Drug Development

Kashiv Biosciences Announces Successful Phase 1 Study Results of ADL018, A Biosimilar Candidate to Xolair® (omalizumab)

Kashiv Biosciences, LLC announced that ADL018, a biosimilar candidate to Xolair®, completed a successful global Phase 1 clinical study in healthy volunteers.

July 5, 2023

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3 min read

Press Releases

TuHURA Biosciences (Nasdaq: HURA) Announces Webcast Replay of Panel Presentation at the 2024 Maxim Healthcare Virtual Summit, Presented by Maxim Group LLC

October 24, 2024

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1 min read

FDA

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

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®.

May 31, 2022

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4 min read

Deals

Theseus Pharmaceuticals Confirms Receipt of Unsolicited Expression of Interest from Foresite Capital, LLC and OrbiMed Advisors LLC and Unsolicited Proposal from Concentra Biosciences LLC

Theseus Pharmaceuticals Confirms Receipt of Unsolicited Expression of Interest from Foresite Capital, LLC and OrbiMed Advisors LLC and Unsolicited Proposal from Concentra Biosciences LLC.

November 27, 2023

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4 min read

FDA

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

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®.

March 2, 2022

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4 min read