LTT Biopharma Interstitial Pneumonia Drug Obtains MHLW Orphan Status
This article was originally published in PharmAsia News
Executive SummaryThe First Committee on New Drugs at the Ministry of Health, Labor and Welfare June 4 granted orphan drug status to LTT Biopharma's midismase (recombinant) for interstitial pneumonia. Midismase is a lecithinized superoxide dismutase (PC-SOD) that is in Phase II clinical trials in Japan. Tokyo-based LTT specializes in developing new drug delivery systems, and the orphan status will accelerate the regulatory approval process and help obtain financial assistance. (Click here for more - Japanese language)"LTT Biopharma Shares Jump Due To Obtaining Orphan Drug Status For New Drug" - Search China News (6/7/2010)
You may also be interested in...
The Gilead subsidiary presented updated data at ASH for its first CD19-targeting CAR-T Yescarta and pivotal results for KTE-X19, which it plans to submit for US FDA approval in mantle cell lymphoma this year.
Hiring travails, inspection pre-announcement, lack of translators highlighted in congressional hearing on FDA foreign inspections.
The court included its decision on Amarin’s ’s petition for a writ of certiorari among the single-line denials of nearly 200 appeals to consider decisions in civil litigation and convictions in criminal cases. However, Amarin still eyes curbing competition from omega-3 supplements.