Industry intelligence
Stay current with the latest developments in peptide therapeutics, biosimilar regulation, and pharmaceutical manufacturing.
New guidance clarifies compounding requirements for outsourcing facilities producing biologics under Section 506(e) of the FD&C Act, impacting GLP-1 and insulin manufacturers.
Phase III data from multiple biosimilar programmes demonstrate pharmacokinetic equivalence and comparable weight-loss outcomes to the originator tirzepatide molecule.
US-based manufacturers are scaling solid-phase peptide synthesis capacity to meet surging demand for GLP-1 agonists and reduce dependence on overseas API suppliers.
Analyst forecasts point to continued explosive growth in the GLP-1 therapeutic class, driven by obesity, type 2 diabetes, and emerging cardiovascular indications.
The United States Pharmacopeia has released updated Chapter <797> standards with new requirements for sterility testing, beyond-use dating, and environmental monitoring.
A landmark comparative study provides clarity on differential efficacy and tolerability profiles, helping clinicians navigate the rapidly expanding GLP-1 landscape.
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