MHLW Designates Biogen Idec’s MS Drug Natalizumab Orphan Drug
This article was originally published in PharmAsia News
Executive Summary
The first session of Japan's Ministry of Health, Labor and Welfare's drug review board designated Biogen Idec's natalizumab an orphan drug April 25. Marketed under Tysabri, natalizumab is approved in the United States for treating relapsing forms of multiple sclerosis, and in the European Union for relapsing-remitting forms of MS. Biogen Idec Japan, the American company's Japanese subsidiary plans to start clinical trials in Japan soon. (Click here for more - Japanese language)
You may also be interested in...
Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children
Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.
MAISI: Navigating The 'Valley Of Death' In Medtech Research Translation
Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.
Incyte Hopes To Augment Immune/Inflammation Pipeline With Escient Deal
Incyte will pay $750m to acquire privately held Escient and its first-in-class oral antagonists of Mas-related G protein-coupled receptors X2 and X4.