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

BioMarin Rolls Up Sleeves To Prepare For Roctavian’s EU Debut

Positive CHMP Opinion Makes Approval Likely

Executive Summary

The company plans to start in Germany with an outcomes-based payment model. But while a US FDA nod seems likely, analysts have been more cautious about calling US approval a done deal.

You may also be interested in...



Japan-Specific Approval For Hemlibra In Acquired Hemophilia A

Hemlibra receives new approval in Japan intractable disease indication, while positive Phase III results in mild/moderate disease hemophilia A will support a planned EU filing in this setting. 

Novo Nordisk’s Concizumab Could Be First In New Class For Hemophilia

Phase III data for the drug showed strong efficacy among hemophilia A and B patients with inhibitors. The drug’s approval would help drive continued segmentation of the hemophilia market.

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast version of Five Must-Know Things: a look a top executive compensation; BioMarin preps for Roctavian’s EU debut; Argenx eyes launch hat-trick for Vyvgart; is a biopharma M&A wave coming; and J&J’s Gorsky offers leadership lessons.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC146614

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