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Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals drugs
July 21, 2021
Provention announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
Provention Bio wins FDA panel backing for teplizumab to delay type 1 diabetes firstwordpharma
May 31, 2021
An FDA advisory committee on Wednesday tipped in favour of recommending approval for Provention Bio's teplizumab to delay the onset of type 1 diabetes in at-risk individuals.
Provention Bio Initiates First-in-Human Study of Coxsackievirus B Vaccine Candidate PRV-101 americanpharmaceuticalreview
January 06, 2021
Provention Bio announced the initiation of PROVENT (PROtocol for coxsackievirus VaccinE in healthy voluNTeers), a first-in-human study of its polyvalent inactivated coxsackievirus B (CVB) vaccine candidate, PRV-101.
FDA approval of Provention Bio’s Teplizumab could bring first disease-modifying therapy to type 1 diabetes space expresspharma
November 27, 2020
If Provention Bio’s rolling Biologic License Application (BLA) submission to the FDA for teplizumab is approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes (T1D).
Provention Bio Begins Phase 2 Study of Non-responsive Celiac Disease Treatment americanpharmaceuticalreview
September 01, 2020
Provention Bio announced the initiation of the Phase 2b PROACTIVE (PROvention Amgen Celiac ProtecTIVE) study of PRV-015, an anti-interleukin-15 monoclonal antibody, in adult celiac patients not responding to a gluten-free diet, a condition known as ...
AGC Biologics Completes PPQ Mfg. Campaign with Provention Bio contractpharma
August 27, 2020
AGC Biologics, achieved the on-schedule completion of a drug substance Process Performance Qualification (PPQ) campaign, focused on teplizumab (PRV-031) for partner Provention Bio.
Provention Bio Initiates Rolling Submission of BLA for Teplizumab for Type 1 Diabetes americanpharmaceuticalreview
April 17, 2020
Provention Bio announced the initiation of the rolling submission of the Company's Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for teplizumab (PRV-031).
Provention Bio Provides Pauses Type 1 Diabetes Treatment Study americanpharmaceuticalreview
March 20, 2020
Provention Bio announced a temporary pause in the randomization of patients with newly diagnosed type 1 diabetes (T1D) into its global Phase 3 PROTECT study of PRV-031 (teplizumab).
Provention Bio Announces Breakthrough Therapy Designation for Teplizumab americanpharmaceuticalreview
August 07, 2019
Provention Bio announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease.
Provention Bio to develop Amgen’s celiac disease candidate pharmaceutical-technology
November 10, 2018
Biopharmaceutical company Provention Bio has agreed to further develop Amgen’s AMG 714 drug candidate for the treatment of gluten-free diet non-responsive celiac disease (NRCD).

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