EMA Releases API Bioequivalence Studies Guidance

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

This podcast explores the challenges of and the progress made so far by the biopharma industry toward alternative drug delivering methods for biologic drugs.

Stoboclo and Osenvelt (both denosumab-bmwo) reference Amgen’s Prolia and Xgeva, respectively.

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.

As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.