Jill Murphy

The decision was based on results from the PROpel Phase III trial.

This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.

Additionally, the MSG discussed plans to mitigate shortages of antibiotics for the next autumn and winter season.

Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, discusses point of care and patient manufacturing with Pharmaceutical Technology editor Jill Murphy.

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

The COVID-19 pandemic has led to many changes and shifts in the pharmaceutical industry, specifically with how pharmaceutical companies develop vaccines.

Normand Blais, senior director of Development and Innovation in Biologics at BIOVECTRA, and Jessica Madigan, director of Business Development in Biologics at BIOVECTRA, discuss all things vaccine with Pharmaceutical Technology editor Jill Murphy.

The COVID-19 pandemic has led to many changes and shifts in the pharmaceutical industry, specifically with how pharmaceutical companies develop vaccines.

CMOs are hoping to grow outsourcing to significantly higher levels in many different areas, with a focus on analytical testing, toxicity testing, and fill/finish operations.