News round-up for 19-23 June by DDW Digital Content Editor Diana Spencer.
Advanced Therapy Medicinal Products (ATMPs) have been making the news this week. Particularly noteworthy have been the announcement of the FDA’s approval of the first gene therapy for Duchenne muscular dystrophy, and a caution from the Alliance for Regenerative Medicine (ARM) against the implementation of strict new clinical assessment rules in the EU.
The top stories:
The proposed joint clinical assessment methodology would have rejected nearly 90% of the ATMPs currently authorised in the EU, claims the Alliance for Regenerative Medicine (ARM).
Evox Therapeutics has purchased Codiak Biosciences engEx-AAV technology platform, including all intellectual property rights, and exclusive access to certain engineering and manufacturing rights.
Sarepta Therapeutics’ Elevidys has become the first gene therapy for Duchenne muscular dystrophy (DMD) to gain marketing authorisation in the US.
This webinar will help you understand the AAV workflow, from upstream methods for AAV production and validation to downstream analysis of the packaged product for enhanced therapeutic development.
Contract development and manufacturing organisation (CDMO) SCTbio and cell therapy company Cyto-care.eu have teamed up with the aim of improving the quality of cryopreservation in Europe.