Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

How Are Japan’s Regenerative Meds Regs Playing Out?

This article was originally published in PharmAsia News

Executive Summary

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 Bounces Back From Failed Japan Invossa Deal With Bigger Mundipharma Alliance

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.

Japan’s Conditional Approval System Passes Test With Global First Lorlatinib Nod

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. 

Mesoblast’s Late-Stage Pipeline Could Be Game Changing: Are Investors Paying Attention?

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.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC089377

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel