Contract Manufacturing Insulin Regulation Sales 
pharmaphorum
JULY 7, 2021
Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contract manufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.
pharmaphorum
MARCH 21, 2022
Now, the regulator has accepted the resubmission, kicking off another six-month review period as teplizumab has previously been awarded breakthrough status. Teplizumab is thought to work by binding to CD3, preventing the activation of T cells that attack and kill insulin-producing pancreatic beta cells in the autoimmune disease.
pharmaphorum
NOVEMBER 18, 2022
The US regulator has approved the anti-CD3 antibody as Tzield to delay the onset of stage 3 T1D in people eight years and older who currently have stage 2 disease, which according to the FDA “may provide patients with months to years without the burdens of disease.”
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