Japan's Teijin To Apply For U.S.-Approved Gout Drug In Japan, Europe
This article was originally published in PharmAsia News
Executive Summary
Teijin Pharma of Japan says it is ready to seek approval in Japan and Europe to market a gout drug TMX-67 (febuxostat) that the maker expects will become a blockbuster. Teijin has had trouble getting the drug approved in Japan, where regulatory authorities required additional clinical trials, so Teijin plans to reapply this year, in time to release it locally in 2011. Takeda Pharmaceutical markets Teijin's drug in the United States as Uloric. (Click here for more - a subscription may be required
You may also be interested in...
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
How Ochre Bio Bagged Boehringer For Its RNA-Based Regenerative MASH Therapies
UK-based Ochre Bio has signed its first major deal with Boehringer Ingelheim. Scrip talked to its co-founder and CEO, Jack O’Meara, about its human tissue-based drug discovery platform, its resulting RNA platform for liver disease and how the fledgling drug company's early work mirrored that seen in diagnostics.
IGI Bets On Trispecific Antibody To Make Inroads Into Big Pharma Myeloma Turf
Ichnos Glenmark Innovation’s president and CEO talks to Scrip about the promising activity profile of the alliance’s early stage trispecific antibody versus Janssen’s teclistamab and also maintains that the setback for Gilead’s magrolimab hasn’t eclipsed prospects for its bispecific antibody.