pharmaphorum

JULY 7, 2021

The complete response letter (CRL) for teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals reiterates the FDA’s concerns around the pharmacokinetics (PK) data for the antibody.

Drugs 98

Drugs Insulin Contract Manufacturing Antibody 98

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

pharmaphorum

MARCH 21, 2022

Provention has modified its 14-day treatment course with teplizumab to match the exposure to the drug that was seen with the clinical trial material, and has also submitted responses to FDA questions about manufacturing and product quality.

Drugs 52

Drugs Insulin Contract Manufacturing Clinical Trials 52

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.”

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

Roots Analysis

JANUARY 27, 2025

Further, as can be observed from the figure, the microbial CMO market features the presence of small, mid-sized, large and very large companies having the required expertise to offer contract manufacturing services across the globe. Key Trends in the Microbial CMO Market A. Key Growth Drivers 1.

Marketing 40

Marketing Manufacturing Production Development 40