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Applicable"},{"orgOrder":0,"company":"TG Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Large molecule","year":"2022","type":"Not Applicable","leadProduct":"Ublituximab","moa":"CD20","graph1":"Oncology","graph2":"Phase III","graph3":"TG Therapeutics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Intravenous Infusion","sponsorNew":"TG Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"TG Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"TG Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Umbralisib","moa":"PI3K","graph1":"Oncology","graph2":"Approved","graph3":"TG Therapeutics","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Tablet","sponsorNew":"TG Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"TG Therapeutics \/ Not Applicable"}]

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                            01

                            TG Therapeutics

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                            TG Therapeutics

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                            Lead Product(s) : Umbralisib

                            Therapeutic Area : Oncology

                            Study Phase : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            FDA Approval of Lymphoma Medicine Ukoniq (Umbralisib) Is Withdrawn Due to Safety Concerns

                            Details : Ukoniq (umbralisib), is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon, is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma.

                            Brand Name : Ukoniq

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            June 01, 2022

                            Lead Product(s) : Umbralisib

                            Therapeutic Area : Oncology

                            Highest Development Status : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            02

                            TG Therapeutics

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                            TG Therapeutics

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                            Lead Product(s) : Ublituximab,Umbralisib

                            Therapeutic Area : Oncology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            TG Therapeutics Announces Extension of U.S. FDA BLA/sNDA PDUFA Date for Ublituximab Plus UKONIQ® (U2) to Trea...

                            Details : The BLA/sNDA submissions of U2 to treat CLL were based on results of UNITY-CLL trial, comparing the combination of TG-1101 (ublituximab) plus UKONIQ (umbralisib), or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both tre...

                            Brand Name : TG-1101

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            March 03, 2022

                            Lead Product(s) : Ublituximab,Umbralisib

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            03

                            TG Therapeutics

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                            TG Therapeutics

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                            Lead Product(s) : Umbralisib

                            Therapeutic Area : Oncology

                            Study Phase : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            FDA Investigating Possible Increased Risk of Death With Lymphoma Medicine Ukoniq (umbralisib)

                            Details : The results showed a possible increased risk of death in patients receiving the combination of Ukoniq and the monoclonal antibody compared to the control arm. And also experienced more serious adverse events than those in the control arm.

                            Brand Name : Ukoniq

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            February 03, 2022

                            Lead Product(s) : Umbralisib

                            Therapeutic Area : Oncology

                            Highest Development Status : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            04

                            TG Therapeutics

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                            TG Therapeutics

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                            Lead Product(s) : Ublituximab,Umbralisib

                            Therapeutic Area : Oncology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            TG Therapeutics Provides Regulatory Update

                            Details : The UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.

                            Brand Name : TG-1101

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            November 30, 2021

                            Lead Product(s) : Ublituximab,Umbralisib

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            05

                            TG Therapeutics

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                            TG Therapeutics

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                            Lead Product(s) : Umbralisib,Ublituximab

                            Therapeutic Area : Oncology

                            Study Phase : Phase II/ Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            TG Therapeutics Provides Regulatory Update

                            Details : The UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.

                            Brand Name : TGR-1202

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            November 30, 2021

                            Lead Product(s) : Umbralisib,Ublituximab

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase II/ Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            06

                            TG Therapeutics

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                            TG Therapeutics

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                            Lead Product(s) : Umbralisib,Ublituximab,Venetoclax

                            Therapeutic Area : Oncology

                            Study Phase : Phase II/ Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            TG Therapeutics Recaps Schedule of Upcoming Data Presentations at the XIX International Workshop on Chronic Ly...

                            Details : The Company to review the updated Phase 1 data evaluating the investigational combination of UKONIQ® (umbralisib) and ublituximab (U2) plus venetoclax presented at iwCLL, as well as provide an overview of the ULTRA-V Phase 2/3 trial.

                            Brand Name : TGR-1202

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            September 13, 2021

                            Lead Product(s) : Umbralisib,Ublituximab,Venetoclax

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase II/ Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            07

                            Samsung Biologics

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                            Samsung Biologics

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                            Lead Product(s) : Ublituximab,Umbralisib

                            Therapeutic Area : Oncology

                            Study Phase : Phase III

                            Sponsor : TG Therapeutics

                            Deal Size : Undisclosed

                            Deal Type : Collaboration

                            DEALS_DEV arrow-down

                            Samsung Biologics & TG Expand Collaboration for Large Scale Mfg of Ublituximab

                            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 tria...

                            Brand Name : TG-1101

                            Molecule Type : Large molecule

                            Upfront Cash : Undisclosed

                            April 26, 2021

                            Lead Product(s) : Ublituximab,Umbralisib

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase III

                            Sponsor : TG Therapeutics

                            Deal Size : Undisclosed

                            Deal Type : Collaboration

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                            08

                            TG Therapeutics

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                            TG Therapeutics

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                            Lead Product(s) : Umbralisib

                            Therapeutic Area : Oncology

                            Study Phase : Approved

                            Sponsor : Rhizen Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Rhizen Pharma Announces that Umbralisib Received US FDA Accelerated Approval for Relapsed or Refractory MZL & ...

                            Details : Umbralisib (UKONIQ) granted accelerated approval by US FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL), follicular lymphoma (FL).

                            Brand Name : Ukoniq

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            February 08, 2021

                            Lead Product(s) : Umbralisib

                            Therapeutic Area : Oncology

                            Highest Development Status : Approved

                            Sponsor : Rhizen Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            09

                            TG Therapeutics

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                            TG Therapeutics

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                            Lead Product(s) : Umbralisib

                            Therapeutic Area : Oncology

                            Study Phase : Approved

                            Sponsor : Rhizen Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            TG Therapeutics Announces FDA Accelerated Approval of UKONIQ™ (Umbralisib)

                            Details : UKONIQ is the first and only, oral, once daily, inhibitor of phosphoinositide 3 kinase delta and casein kinase 1 epsilon. UKONIQ is approved for adult patients with relapsed or refractory marginal zone lymphoma after at least one prior anti-CD20 based re...

                            Brand Name : Ukoniq

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            February 05, 2021

                            Lead Product(s) : Umbralisib

                            Therapeutic Area : Oncology

                            Highest Development Status : Approved

                            Sponsor : Rhizen Pharmaceuticals

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            TG Therapeutics

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                            TG Therapeutics

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                            Lead Product(s) : Umbralisib,Ublituximab

                            Therapeutic Area : Oncology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            TG Therapeutics Starts Rolling Submission of BLA to U.S. FDA for Ublituximab and Umbralisib Combo to treat Chr...

                            Details : TG Therapeutics has initiated a rolling submission of a Biologics License Application to the U.S. FDA requesting approval of ublituximab, a glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, an oral, dual inhibitor of PI3K-del...

                            Brand Name : TGR-1202

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            December 01, 2020

                            Lead Product(s) : Umbralisib,Ublituximab

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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