[{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Provides Update on the Status of Its Phase 3 PROTECT Study for the Treatment of Newly Diagnosed Type 1 Diabetes","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Initiates Rolling Submission of Biologic License Application for Teplizumab","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio and Vactech Announce Publication of Proof-of-Concept Data for a Preclinical Prototype of Coxsackievirus B Vaccine","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio's Teplizumab Continued to Significantly Delay the Onset of Insulin-Dependent Type 1 Diabetes (T1D) in Presymptomatic Patients","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"SVB Leerink","pharmaFlowCategory":"D","amount":"$95.7 million","upfrontCash":"Undisclosed","newsHeadline":"Provention Bio Announces Pricing of $95.7 Million Public Offering of Common Stock","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Announces Initiation of Phase 2b PROACTIVE Study of PRV-015 (anti-IL-15) in Non-responsive Celiac Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase II"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Beyond Celiac","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Beyond Celiac Partners with Provention Bio on Phase 2 Clinical Trial for Promising Celiac Disease Therapeutic","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase II"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Files Clinical Module for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Provention Bio","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Celiac Disease Foundation Partners with Provention Bio on Its Phase 2b Study of Celiac Disease Therapeutic PRV-015","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase II"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Completes Rolling Submission of the BLA for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Initiates First-in-Human Study of Coxsackievirus B Vaccine Candidate PRV-101","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Provention Bio","sponsor":"SVB Leerink","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"Provention Bio Announces Pricing of $100 Million Public Offering of Common Stock","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Huadong Pharmaceutical","pharmaFlowCategory":"D","amount":"$293.0 million","upfrontCash":"$6.0 million","newsHeadline":"Provention Bio and Huadong Announce Strategic Collaboration to Develop and Commercialize PRV-3279 in Greater China","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Phase I"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Provides Regulatory Update Regarding BLA of Teplizumab For Patients at Risk of Getting Clinical Type 1 Diabetes","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Provides Additional Regulatory Update on Biologics License Application for Teplizumab for Clinical Type 1 Diabetes","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Advisory Committee Votes in Favor of the Benefits of Teplizumab Outweighing the Risks in Support of Approval to Delay Clinical T1D","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Receives CRL to Biologics License Application for Teplizumab for Delay of Clinical Type 1 Diabetes in At-Risk Individuals","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Provides Update on the Potential Timing of Teplizumab At-Risk Type 1 Diabetes BLA Resubmission","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Provides Regulatory Update for Teplizumab At-Risk Type 1 Diabetes Approval Pathway","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Announces FDA Acceptance of the Biologics License Application (BLA) Resubmission for Teplizumab for the Delay of Clinical Type 1 Diabetes in At-Risk Individuals","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Provention Bio Announces Positive Final Results from First-In-Human Study of Coxsackievirus B Vaccine Candidate PRV-101","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"$55.0 million","upfrontCash":"$20.0 million","newsHeadline":"Provention Bio to Combine Forces with Sanofi to Support Potential U.S. Launch of Teplizumab for Delay in Onset of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II"},{"orgOrder":0,"company":"Provention Bio","sponsor":"MacroGenics","pharmaFlowCategory":"D","amount":"$395.0 million","upfrontCash":"Undisclosed","newsHeadline":"MacroGenics Earns $60 Million Milestone with U.S. FDA Approval of Teplizumab","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Hercules Capital","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Provention Bio Announces Closing of Second Tranche with Hercules Capital to Support U.S. Commercial Launch of TZIELD\u00ae","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"$35.0 million","upfrontCash":"Undisclosed","newsHeadline":"Provention Bio Announces Completion of $35 Million Equity Investment from Sanofi US","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"$2,900.0 million","upfrontCash":"$2,900.0 million","newsHeadline":"Sanofi To Acquire Provention Bio, Adding To Portfolio Tzield, The First Disease-modifying Treatment For The Delay Of Stage 3 Type 1 Diabetes (T1D)","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Provention Bio","sponsor":"AGC Biologics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"AGC Biologics to Commercial Manufacture Provention Bio Diabetes Therapy","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Provention Bio","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"$2,900.0 million","upfrontCash":"$2,900.0 million","newsHeadline":"Sanofi Completes Acquisition of Provention Bio, Inc.","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Provention Bio
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).
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).
The financing will be used to support the commercial launch of TZIELD (teplizumab-mzwv). TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D.
Tzield (teplizumab-mzwv) is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D.
Under the agreement, AGC Biologics will manufacture TZIELD™ (teplizumab-mzwv), a new T1D treatment. TZIELD is the first and only immunomodulatory treatment that delays the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older.
Under the terms of the agreements held in 2018, Provention has acquired all rights to Tzield (teplizumab) to be further developed as PRV-031 and licensing rights to MGD010 for development as PRV-3279.
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 immune response.
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.
PRV-101 is an investigational polyvalent vaccine being developed for the prevention of acute coxsackievirus B (CVB) infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease.
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.
Market Place
Upload your Marketing & Sales content on your company Virtual Booth, click HERE
