1. Scrip
  2. >>R&D

US R&D Setbacks For Multiple Japanese Firms

Missed Endpoint, CRL

 
• By Lisa Takagi and Ian Haydock

Several Japanese firms are facing R&D challenges and setbacks in the US, in the form of missed Phase III endpoints, trial recruitment difficulties and a Complete Response Letter.

Nippon Shinyaku and Mitsubishi Tanabe both faced R&D setbacks in the US.
Nippon Shinyaku facing multiple US challenges aid looming LOE • Source: Shutterstock

While many many Japanese firms have shifted much of their commercial and R&D focus to the US, several have recently faced development setbacks that could affect their mid-term outlook in this huge market.

Nippon Shinyaku Co., Ltd.’s Duchenne muscular dystrophy (DMD) therapeutic Viltepso (viltolarsen) recently missed its primary efficacy endpoint in preliminary...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from R&D

Scholar Rock Shows Muscle-Building PoC In Obesity

 
• By Jessica Merrill

The company said it intends to maintain a focus on rare neuromuscular disease with apitegromab but could consider partnering in obesity.

Spyre Takes Aim At Roche And J&J In Inflammatory Diseases

 
• By Andrew McConaghie

The US firm was already looking to compete in ulcerative colitis, but now expands its ambitions by moving into rheumatoid arthritis as well.

Ireland’s Got Biopharma Talent To Keep Leading The Pack

 
• By Kevin Grogan

The country’s life sciences investment head tells Scrip that it is business as usual for the sector despite the rumblings from across the Atlantic.

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By Kevin Grogan

Wales-based group launches with $140m series A.

More from Scrip

Ireland’s Got Biopharma Talent To Keep Leading The Pack

 
• By Kevin Grogan

The country’s life sciences investment head tells Scrip that it is business as usual for the sector despite the rumblings from across the Atlantic.

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By Kevin Grogan

Wales-based group launches with $140m series A.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 
• By Sarah Karlin-Smith and Mandy Jackson

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.