How Are Japan’s Regenerative Meds Regs Playing Out?
This article was originally published in PharmAsia News
Nearly 18 months has passed since Japan formally adopted ground-breaking new and revised legislation governing the regulation of cell and tissue therapies in November 2014, but how is the new framework working out in practice?
You may also be interested in...
Kolon Life Science has reached a sizable license deal with Mundipharma for the development in Japan of the South Korean company’s first-in-class cell and gene therapy for osteoarthritis of the knee, easing uncertainties after an agreement with Mitsubishi Tanabe for the product collapsed last year.
Pfizer’s ALK inhibitor gets its first marketing clearance globally as a second-line indication, showing Japan's so far untested scheme is working as it should to enable early access.
Mesenchymal cell specialist Mesoblast came back from a near-death experience in 2016 when Teva returned a key asset. But recent success in a Phase III trial in acute GVHD has brought it some attention. Now it needs to repeat the achievement in advanced heart failure and find a partner for its burgeoning pipeline.