FDA Approval of Three Regenerative Medical Products
As we enter the latter half of this year, an astonishing three regenerative medical products (two gene therapies and one cell therapy) have received FDA approval in the past 10 days alone.
#Biomarin: Hemophilia A #Sarepta: Duchenne muscular dystrophy #CellTrans: Type 1 diabetes
I have a strong sense that the market for CGT (Cell and Gene Therapy) will continue to heat up in the future.
In Japan, there are unique rules like the “Biological Source Material Standards,” and within the PMDA led by Mr. Maruyama, there is a newly established department for the review of regenerative medical products. This calls for a slightly different approach to drug development compared to FDA and EMA.
For pharmaceutical companies interested in candidates with practical experience in these areas, including immediate contributors, leader-class individuals, contract employees, and dispatched employees, please feel free to contact us.