1. Scrip
  2. >>Focus On Asia
  3. >>Japan

Takeda Avoids REMS For Entyvio, But Must Continue PML Monitoring

 
• By Derrick Gingery

FDA approves drug for ulcerative colitis and Crohn’s disease patients who have failed other therapies, but requires heightened adverse event reporting and post-marketing study.

FDA still intends for Takeda Pharmaceutical Co. Ltd. to watch for progressive multifocal leukoencephalopathy during marketing of its ulcerative colitis and Crohn’s disease drug Entyvio, even though the infection did not surface during clinical trials.

Takeda was able to avoid a Risk Evaluation and Mitigation Strategy for the product, but its indication for use after...

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 Japan

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get those submissions in by this date. Sponsorship opportunities and tables for the event are also available.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

Japan Pharma Sees US Revenues Grow But Policy Impact Still Unclear

 
• By Lisa Takagi

Japanese majors put in generally solid performances in the fiscal year ended 31 March, but overseas revenues and forex effects, rather than the domestic market, provided most of the growth.

More from Focus On Asia

AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

 
• By Andrew McConaghie

After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.

Is Zydus’s Agenus Deal Opportunistic Or Strategic?

 
• By Vibha Ravi

Will Zydus’s acquisition and licensing deal with Agenus turn out to be a strategic move towards building an oncology portfolio or an opportunistic one driven by a venture capital mindset?

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get those submissions in by this date. Sponsorship opportunities and tables for the event are also available.