FDA declines to approve Provention Bio’s teplizumab for diabetes
The US Food and Drug Administration (FDA) has declined to approve Provention Bio’s biologics licence application (BLA) for teplizumab in type 1 diabetes (T1D), an autoimmune disease.
July 8, 2021
by pharmaceutical-technology
Intravacc Completes Project for Provention Bio’s Vax Candidate
Contract development and manufacturing organization (CDMO) Intravacc, said that a candidate polyvalent inactivated coxsackievirus B (CVB) vaccine it developed and manufactured for Provention Bio in less than 36 months, has entered into a first in ...
January 20, 2021
by contractpharma
Provention Bio Announces Teplizumab BLA for Delay or Prevention of Clinical T1D
Provention Bio announced the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA).
January 11, 2021
by americanpharmaceuticalreview
Provention Announces Positive Data from Lupus Treatment Study
Provention Bio announced positive top-line results from the Phase 1b portion of the PREVAIL (PRV-3279 EVAluation In Lupus) study evaluating PRV-3279 in healthy volunteers.
March 19, 2020
by americanpharmaceuticalreview
Provention Bio Appoints Clinical Development SVP
Dr. Kell will lead the PRV-031 program, including the oversight of the Phase III PROTECT study and support of regulatory submissions.
August 21, 2019
by contractpharma
Provention Bio Initiates Trial Evaluating PRV-3279 in Lupus
Provention Bio has dosed the first patients in its PREVAIL (PRV-3279 EVAluation In Lupus) study, a Phase 1b/2a clinical trial evaluating PRV-3279. PRV-3279 is a humanized diabody (a bispecific scaffold biologic molecule) targeting the B-cell surface prote
August 9, 2019
by americanpharmaceuticalreview
Provention’s PRV-031 found to delay type II diabetes by two years
A single course of Provention’s PRV-031 (teplizumab) has been found to delay type I diabetes onset in high-risk individuals by at least two years.
June 11, 2019
by pharmatimes
Provention Bio Announces Top-Line Results from its PRV-300 Trial
Provention Bio Announces Top-Line Results from its PRV-300 Trial.
May 10, 2019
by americanpharmaceuticalreview
Provention Bio Initiates Phase 3 PROTECT Clinical Trial with PRV-031 (Teplizumab) in Patients with Recent Onset Type 1 Diabetes
Provention Bio Initiates Phase 3 PROTECT Clinical Trial with PRV-031 (Teplizumab) in Patients with Recent Onset Type 1 Diabetes.
April 17, 2019
by drugs
Janssen deal gives new kid in town Provention two immune candidates
Right on the heels of a $28 million seed financing, Provention Bio has snapped up two inflammatory bowel disease candidates from Janssen that should make it a double clinical-stage biotech next year.
September 22, 2017
by fiercebiotech