In Vivo 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

Big In Japan: Assessing Seven Years Of Sakigake

11 Global-First Approvals

Executive Summary

Japan’s fast-track approval system for innovative drug candidates has marked its seventh year since launch, during which it has accepted 27 candidates with 13 of these moving to approval. But in recent years the system has faced a decreasing number of admitted candidates, this original infographic analysis shows.

You may also be interested in...



Rocky Road To Glioma Approval: BNCT Firm Stella Redesigns Japan PII Trial

Japanese bioventure Stella Pharma is re-designing a Phase II trial for its glioma candidate Steboronine after it was determined the original primary endpoint was not robust enough to prove efficacy, a challenge faced by some others working in the difficult indication. The drug was approved for head and neck cancer in Japan in 2020 and Stella has already announced a new collaboration which may be key to moving forward. 

Japan Regulators Kept On Track Despite Pandemic

While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year. 

PMDA Eyes More Japan-First Approvals In Access Push

Highlighting progress it has made over the past few years, Japan’s regulatory agency says it wants to raise even further the number of “Japan-first” approvals, as part of its stated mission to get safe and effective new drugs to patients more quickly.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

IV146711

Ask The Analyst

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

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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