November 21st 2024
The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.
Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.
Is FDA's Draft Process-Validation Guidance a Mixed Blessing?
August 19th 2009The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help pharmaceutical companies achieve consistently high product quality.
Companies Update Activities for Pandemic and Seasonal Flu Vaccines
August 13th 2009Baxter International (Deerfield, IL), sanofi aventis (Paris), and Novartis (Basel, Switzerland) provided updates last week of their production and regulatory activities relating to preparedness in supplying the A(H1N1) pandemic influenza vaccine. Novartis also outlined its activities for providing seasonal flu vaccines.