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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...

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More from Japan

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.

Multiple Launches Help Lilly’s Japan Growth

 
• By Ian Haydock

Lilly saw solid growth for its business in Japan last year on the back of several new launches and is building its obesity and Alzheimer's portfolios in the country.

Shionogi In $1bn Deal For Japan Tobacco’s Pharma Ops

 
• By Ian Haydock

Mid-sized Japanese pharma firm to acquire tobacco giant’s pharma operations and take private the listed Torii Pharmaceutical business, in bid to build sales reach and strengthen manufacturing.

More from Focus On Asia

Public Health And Innovation: Addressing Gaps, Pharma’s Role

 
• By Anju Ghangurde

Expert panel including Ashok Venkitaraman, director of the Cancer Science Institute of Singapore, discusses public health challenges and innovations to help address these. Long-acting drugs, intercepting cancer early and “design thinking” by ophthalmologists in India were among the talking points.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.