Pharmaceutical Technology

JULY 15, 2022

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin.

Insulin 328

Insulin Manufacturing Contract Manufacturing Production 328

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.

Drugs 98

Drugs Insulin Contract Manufacturing Antibody 98

Roots Analysis

JANUARY 23, 2024

The peptide therapeutics market has undergone substantial evolution since the inception of insulin. It is noteworthy that peptide is a complex class of drugs that possess many manufacturing challenges, including complex process and big-budget development and manufacturing.

Development 40

Development Contract Manufacturing Drugs Manufacturing 40

pharmaphorum

MARCH 21, 2022

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. In the latter, teplizumab wasn’t able to show an impact on insulin use or HbA1c, an indirect measure of glucose control over time.

Drugs 52

Drugs Insulin Contract Manufacturing Clinical Trials 52

pharmaphorum

NOVEMBER 18, 2022

” T1D occurs when the immune system attacks and destroys the insulin-producing pancreatic beta cells that make insulin, and occurs in three stages. In stage 1 there are antibodies against the beta calls, but blood glucose levels remain normal and there are no symptoms.

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

The Pharma Data

JANUARY 5, 2021

Novasep’s chromatography unit comprises resin-based batch and intensified chromatography systems, and primarily focuses on high-pressure, multi-use applications for smaller molecules, such as oligonucleotides, peptides and insulin.

Manufacturing 40

Manufacturing Sales Contract Manufacturing Insulin 40

Pharmaceutical Technology

JANUARY 30, 2023

This is mixed news for contract manufacturing organisations (CMOs), as large CMOs such as Thermo Fisher Scientific (Waltham, MA, US) and Catalent Inc (Somerset, NJ, US) are typically involved in the manufacture of the most innovative products. The drug increases insulin synthesis and release.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130