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

Japan Approvals Include World Firsts For Romosozumab, Spinal Injury Cell Therapy

Executive Summary

The latest group of new product approvals in Japan includes the first marketing clearances worldwide for fracture-reducing osteoporosis antibody romosozumab and a stem cell-based therapy for spinal cord injury, as well as two new Daiichi drugs and Pfizer's lung cancer therapy dacomitinib. 

You may also be interested in...



Amgen Launches Evenity For High-Risk Osteoporosis At $21,900 List Price

Amgen EVP Murdo Gordon highlighted the unmet need for women at high risk, including those with a prior fracture. At $1,825 per month or $21,900 for a one-year course in the US, he says Evenity's cost is much lower versus competing 18- and 24-month anabolic agents.

PMDA Chief Defends Japan Spinal Cord Therapy Approval

The head of Japan’s drug and device regulator has defended and supported the country’s recent world-first decision to grant approval to a novel cell-based therapy for spinal cord injuries, saying that patient considerations came first.

Surprising SanBio/Sumitomo Stroke Stumble Slams Stocks

Mesenchymal stem cell-based therapy's missed Phase IIb endpoint in stroke prompts both an assessment of future development plans and a precipitous fall in developers' stocks.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124559

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