EMA Releases API Bioequivalence Studies Guidance

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Using splicing technology, the new company aims to innovate safer and more effective RNA therapies for severe genetic diseases.

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.