Pink Sheet 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

Zolgensma: Bumpy Japan Review Holds Lessons For Applicants

‘Numerous And Extensive’ Problems

Executive Summary

Product review report reveals multiple delays and missteps on route to market, holding valuable lessons for other gene therapy developers but also evidencing an ultimately welcoming environment.

You may also be interested in...



New Japan PMDA Head Brings Strong Clinical, Patient Focus To Role

The main priorities for the new chief executive of Japan’s drugs regulator over the next five years include putting patients first by promoting early access while ensuring safety, further strengthening pharmacovigilance as new forms of therapy come through, and increasing collaboration with Asia, as the agency looks to meet the challenges of changing technologies.

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: the shifting sands of pharma R&D; big pharma oncology strategies; semaglutide’s promise in heart failure; AstraZeneca looks to multiple cancer modalities; and an interview with Astellas’s chief strategy officer.

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: Genmab buys into ADCs; Roivant set to take on AbbVie in uveitis; Ipsen signs firs ADC pact; South Korea looks to build biotech momentum; and the end of the road for Acorda.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS143182

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