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    [{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Endocrinology","country":"U.S.A","productType":"Large molecule","year":"2020","type":"Not Applicable","leadProduct":"Teplizumab","moa":"","graph1":"Endocrinology","graph2":"Phase III","graph3":"Provention Bio","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Endocrinology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Provention Bio \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Provention Bio \/ Not Applicable"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Endocrinology","country":"U.S.A","productType":"Large molecule","year":"2020","type":"Not Applicable","leadProduct":"Teplizumab","moa":"","graph1":"Endocrinology","graph2":"Phase III","graph3":"Provention Bio","amount2":0,"highestDevelopmentShortName":"Ph 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Bio","sponsor":"Sanofi","pharmaFlowCategory":"D","therapeuticArea":"Endocrinology","country":"","productType":"Large molecule","year":"2023","type":"Acquisition","leadProduct":"Teplizumab","moa":"","graph1":"Endocrinology","graph2":"Approved","graph3":"Provention Bio","amount2":2.8999999999999999,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Endocrinology","amount2New":2.8999999999999999,"dosageForm":"Injectable\/Injection","sponsorNew":"Provention Bio \/ Sanofi","highestDevelopmentStatusID":"12","companyTruncated":"Provention Bio \/ Sanofi"}]

    Find Clinical Drug Pipeline Developments & Deals for Teplizumab

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                            01

                            Provention Bio

                            U.S.A
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                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Study Phase : Approved

                            Sponsor : Sanofi

                            Deal Size : $2,900.0 million

                            Deal Type : Acquisition

                            DEALS_DEV arrow-down

                            Sanofi Completes Acquisition of Provention Bio, Inc.

                            Details : Through the acquisition of Provention Bio, Sanofi adds to its portfolio, TZIELD (teplizumab-mzwv), a CD3-directed antibody, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D).

                            Brand Name : Tzield

                            Molecule Type : Large molecule

                            Upfront Cash : $2,900.0 million

                            April 27, 2023

                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Highest Development Status : Approved

                            Sponsor : Sanofi

                            Deal Size : $2,900.0 million

                            Deal Type : Acquisition

                            Provention Bio

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                            02

                            Provention Bio

                            U.S.A
                            BMWS24
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                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Study Phase : Approved

                            Sponsor : Sanofi

                            Deal Size : $2,900.0 million

                            Deal Type : Acquisition

                            DEALS_DEV arrow-down

                            Sanofi To Acquire Provention Bio, Adding To Portfolio Tzield, The First Disease-modifying Treatment For The De...

                            Details : Through the acquisition of Provention Bio, Sanofi adds to its portfolio, TZIELD (teplizumab-mzwv), a CD3-directed antibody, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D).

                            Brand Name : Tzield

                            Molecule Type : Large molecule

                            Upfront Cash : $2,900.0 million

                            March 13, 2023

                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Highest Development Status : Approved

                            Sponsor : Sanofi

                            Deal Size : $2,900.0 million

                            Deal Type : Acquisition

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                            03

                            Provention Bio

                            U.S.A
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                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Study Phase : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes

                            Details : Tzield (teplizumab-mzwv) binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the i...

                            Brand Name : Tzield

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            November 17, 2022

                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Highest Development Status : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            04

                            Provention Bio

                            U.S.A
                            BMWS24
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                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase II

                            Sponsor : Sanofi

                            Deal Size : $55.0 million

                            Deal Type : Agreement

                            DEALS_DEV arrow-down

                            Provention Bio to Combine Forces with Sanofi to Support Potential U.S. Launch of Teplizumab for Delay in Onset...

                            Details : Teplizumab (PRV-031), is an investigational anti-CD3 monoclonal antibody that is being evaluated for the delay of clinical type 1 diabetes (T1D) in at-risk individuals, as indicated by the presence of two or more T1D-related autoantibodies.

                            Brand Name : PRV-031

                            Molecule Type : Large molecule

                            Upfront Cash : $20.0 million

                            October 06, 2022

                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Highest Development Status : Phase II

                            Sponsor : Sanofi

                            Deal Size : $55.0 million

                            Deal Type : Agreement

                            Provention Bio

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                            05

                            Provention Bio

                            U.S.A
                            BMWS24
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                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Provention Bio Announces FDA Acceptance of the Biologics License Application (BLA) Resubmission for Teplizumab...

                            Details : Teplizumab, an investigational anti-CD3 mAb developed for delay of clinical type 1 diabetes at-risk individuals, company resubmitted BLA for teplizumab has been considered a complete, class 2 response by USFDA.

                            Brand Name : PRV-031

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            March 21, 2022

                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            Provention Bio

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                            06

                            Provention Bio

                            U.S.A
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                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Provention Bio Provides Regulatory Update for Teplizumab At-Risk Type 1 Diabetes Approval Pathway

                            Details : FDA approved the Company proceeding to populate the popPK model with data collected from patients receiving therapeutic doses of teplizumab in a pharmacokinetic/pharmacodynamic substudy of the ongoing PROTECT Phase 3 trial in newly diagnosed type 1 diabe...

                            Brand Name : PRV-031

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            November 22, 2021

                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            07

                            Provention Bio

                            U.S.A
                            BMWS24
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                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Provention Bio Provides Update on the Potential Timing of Teplizumab At-Risk Type 1 Diabetes BLA Resubmission

                            Details : Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.

                            Brand Name : PRV-031

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            September 13, 2021

                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            Provention Bio

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                            08

                            Provention Bio

                            U.S.A
                            BMWS24
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                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Provention Bio Receives CRL to Biologics License Application for Teplizumab for Delay of Clinical Type 1 Diabe...

                            Details : In the pivotal TN-10 Study, a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least two years in presymptomatic patients with Stage 2 T1D compared to placebo.

                            Brand Name : PRV-031

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            July 06, 2021

                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            09

                            Provention Bio

                            U.S.A
                            BMWS24
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                            • WHO-GMP
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                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            FDA Advisory Committee Votes in Favor of the Benefits of Teplizumab Outweighing the Risks in Support of Approv...

                            Details : Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) with a filed BLA under Priority Review by the FDA for the delay of clinical T1D in at-risk individuals. EMDAC of the U.S. Food and Drug Administration (FDA) voted 10 yes and 7 no on the ...

                            Brand Name : PRV-031

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            May 27, 2021

                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            Provention Bio

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                            10

                            Provention Bio

                            U.S.A
                            BMWS24
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                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Provention Bio Provides Additional Regulatory Update on Biologics License Application for Teplizumab for Clini...

                            Details : Provention Bio took part in an informal meeting with the U.S. Food and Drug Administration (FDA) on April 23, 2021, in connection with the FDA's ongoing review of the teplizumab Biologic License Application (BLA) for the delay or prevention of clinical t...

                            Brand Name : PRV-031

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            April 27, 2021

                            Lead Product(s) : Teplizumab

                            Therapeutic Area : Endocrinology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            Provention Bio

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