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The regulatory environment for the development of mRNA vaccines during COVID-19


By Ciaran Greene

A growing interest in mRNA-based technologies over the last decades has allowed the rapid development and deployment of...


Vaccine Development in Paediatric Populations – How to Proceed for SARS-CoV-2 Vaccines?


By Jerry Fuady

While adult clinical trials of SARS-CoV-2 vaccines have rapidly moved into Phase 3, no clinical trials have been...


How far are we with the accelerated development of SARS-CoV-2 vaccines – a review and outlook


By Noemi Lupo and Michael Pfleiderer

Development of SARS-CoV-2 vaccine comes with an unprecedented number of challenges ranging from CMC to clinical development. This...


Accelerated development and licensure of Coronavirus vaccines


By Michael Pfleiderer

The newly emerging 2019 novel Coronavirus is threatening the world as it spreads with a so far unprecedented...


Platform technologies for vaccines – why is there still no regulatory guidance available?


By Michael Pfleiderer

The recent widespread, long-lasting and recurrent outbreaks of Ebolavirus, Chikungunyavirus, Denguevirus, Zikavirus once more prove the need...


EMA’s Article 58 procedure and WHO’s prequalification procedure – pathways to licensure worth to consider for vaccines and other medicinal products


By Michael Pfleiderer

There are challenges and opportunities for developers of vaccines and other medicinal products needed outside the EU...

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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