Gene Therapy Manufacturing Hitch Solved, Bluebird Aims For European Debut In 2020
First Treatment Expected In Germany
The EMA has declared itself satisfied with ‘refined manufacturing specifications’ for the beta thalassemia treatment
You may also be interested in...
A BLA filing for Zynteglo in beta-thalassemia is expected in the second half of 2020 instead of the first half, but the first commercial patient in the EU will be treated in the first half of this year.
Industry experts expect a continued uptick in deals valued between $2bn-$10bn this year as buyers look to add critical mass in areas like oncology, rare disease and cell and gene therapy. Divestitures to free up capital and narrow focus should continue too.
CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.