MHLW Approves MPS VI Drug Naglzayme
This article was originally published in PharmAsia News
Executive Summary
Osaka-based Anges MG announced that mucopolysaccharidosis VI drug Naglazyme (galsulfase) received manufacturing and marketing approval by Japan's Ministry of Health, Labor and Welfare March 28, three days after it cleared MHLW's drug review panel. The ministry considers Naglazyme the only effective treatment for MPS VI. A severe and progressive genetic disease, MPS is caused by an enzyme deficiency, which leads to progressive organ system dysfunction. Naglazyme has been available in Europe and the U.S and was designated as an orphan drug last June. The NHI price listing will take place in April 18. Anges MG obtained developing and marketing rights in Japan from California-based BioMarin. (Click here for more - Japanese language
You may also be interested in...
There’s ‘No Silver Bullet’ For Making Medicines Packaging Sustainable
There’s no simple answer to the question of how to make medicines packaging sustainable, says international recycling consultancy and Veolia Group subsidiary Circpack. “Manufacturers need to assess what works best for them, and recyclers will do the same,” Circpack analyst and circular packaging expert Filipe Vieira de Castro tells HBW Insight in this exclusive Q&A. “The best thing we can all do is put effort into finding common ground between systems, which comes down to better understanding the complexities between them.”
Entries Begin To Roll In For 2024 Industry Awards
Entries have now begun rolling in for the Global Generics & Biosimilars Awards, which returns to Milan this October, Free to enter and attend, the ceremony recognizes the top achievements across the generics, biosimilars and value added medicines industries.
‘I Would Love To Have All The Biologic Assets’ – Formycon’s Glombitza Sets Out Portfolio Approach
In the second part of an exclusive interview, Formycon CEO Stefan Glombitza talks to Generics Bulletin about key regulatory developments in Europe and the US, the firm’s portfolio selection strategy, and upcoming milestones on the horizon.