Cycle looks to benefit from the advantages of Zydis oral disintegrating tablet technology, developed by Catalent, for four of its drug products treating rare diseases.
Daiichi Sankyo’s Turalio becomes the first FDA-approved TGCT treatment, after receiving breakthrough therapy, priority review and orphan drug designation.
Moderna Therapeutics has announced the opening of a state-of-the-art manufacturing site in Norwood, Massachusetts, built to advance their work in the messenger RNA (mRNA) platform, after announcing the plans for the site in 2016.
While the procedure for designating drugs for orphan diseases has
improved dramatically in the EU, further progress must be made,
says EU biotech group