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Trends in clinical development of tissue-engineered products in the EU


By Dr. Zaklina Buljovcic

While gene therapies are currently on the rise, few tissue-engineered products (TEPs) are being developed.


With ATMP innovation on the rise, sponsors see increase in FDA IND holds


By By Dr. Paula Vaccarello and Dr. Jörg Schneider

With more innovator companies targeting cell and gene therapy, it’s not surprising that investigational new


Understanding diverging expectations between FDA and EMA with cell and gene therapy


By Cori Gorman, Ph.D.

Successfully bringing cell and gene therapies through the regulatory process requires preparation and knowing what


Planning for CBER and EMA success with cell and gene therapy


By Cori Gorman, Ph.D.

The fields of cell and gene therapy are enormously promising while at the same time


Insights into issues and developments from Advanced Therapies Week


By Dr. Jörg Schneider

Dr. Jörg Schneider, Director – Principal Consultant at BioPharma Excellence, shares key takeaways from Advanced


ICH’s viral safety guidelines catch up with the latest biotech innovations


By Sebastian Teitz, Ph.D

More than 25 years after adopting the first version of the guideline on the viral

We are now Cencora PharmaLex 

PharmaLex is now part of Cencora, a leading global healthcare company with a foundation in pharmaceutical distribution. In 2024 and beyond PharmaLex and all the companies in PharmaLex family will begin a journey to becoming Cencora as well. Cencora brings the companies and services together under one new name. The name will change, but the level of attention and service you receive remains the same.  

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