The combined solutions are currently available on the market.
The services are based on the company’s PurePrep EasyClean (PEC) orthogonal peptide purification technology.
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.
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.
CMO growth is focused on analytical testing, toxicity testing, and fill/finish operations.
Pharmaceutical companies have shifted their approach to development of vaccines as a result of the COVID-19 pandemic.