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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): Ublituximab,Umbralisib

            Therapeutic Area: Oncology Product Name: TG-1101

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: TG Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration April 26, 2021

            Details:

            TG Therapeutics has completed a rolling submission of a BLA to the U.S. FDA requesting approval of ublituximab, in combination with UKONIQTM (umbralisib), as a treatment for patients with CLL, based on the positive results from the UNITY-CLL Phase 3 trial.

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            Lead Product(s): Eflapegrastim

            Therapeutic Area: Oncology Product Name: Rolontis

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Spectrum Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 19, 2021

            Details:

            Rolontis," a treatment for neutropenia and "Oraxol," as a treatment for metastatic breast cancer are under priority review by FDA. Hanmi is about to announce the results of their BLA/NDA approval respectively.

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            Lead Product(s): Bevacizumab,Carboplatin,Paclitaxel

            Therapeutic Area: Oncology Product Name: Aybintio

            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 June 26, 2020

            Details:

            AYBINTIO®, a biosimilar candidate referencing Avastin®i (bevacizumab), is Samsung Bioepis’ second oncology biosimilar to be recommended for marketing authorization by the European Medicines Agency.