You are here: Industry Insights > T1D

News List

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.
FDA declines to approve Provention Bio’s teplizumab for diabetes pharmaceutical-technology
July 08, 2021
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.
Experimental immunotherapy significantly delays onset of type 1 diabetes europeanpharmaceuticalreview
March 08, 2021
If approved for use, teplizumab could be the first drug able to delay the onset or completely prevent type 1 diabetes in at-risk groups.
ViaCyte Announces Initiation of Encapsulated Cell Therapy Study for Type 1 Diabetes americanpharmaceuticalreview
February 08, 2021
ViaCyte announced that the first type 1 diabetes (T1D) patients have been implanted in a Phase 2 clinical study utilizing encapsulated delivery of cells.
Provention Bio Announces Teplizumab BLA for Delay or Prevention of Clinical T1D americanpharmaceuticalreview
January 11, 2021
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).
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.
New research reveals impact of childhood type 1 diabetes on mental health pharmatimes
December 16, 2020
New research surveys released by medical device company Abbott have revealed the impact of childhood type 1 diabetes (T1D) on the emotional and mental health of children and their families in the UK.
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).
CymaBay Announces Study to Evaluate GPR119 Agonists to Prevent T1D Hypoglycemia americanpharmaceuticalreview
November 13, 2020
CymaBay Therapeutics will provide its proprietary investigational GPR119 agonist, MBX-2982, and will assist in regulatory filings for a clinical study to be conducted by the TRI.
Precigen ActoBio Announces Positive Topline Results from Type 1 Diabetes Treatment Study americanpharmaceuticalreview
August 13, 2020
Precigen ActoBio has met the primary endpoint assessing safety and tolerability in the Phase 1b monotherapy portion of the ongoing Phase 1b/2a clinical study investigating AG019 ActoBiotics™ for the treatment of early-onset type 1 diabetes (T1D).

Previous page 1 2 Next page