Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
No Additional Safety Measures Needed at this Time for Xocova: Panel
A health ministry safety panel agreed on May 10 that no additional safety measures are needed at this time for Shionogi’s COVID-19 treatment Xocova (ensitrelvir). It was reported that the product’s label was revised in April to warn that women…
To read the full story
Related Article
- Xocova Given to Over 50,000 Patients in 6 Months: Shionogi
June 6, 2023
- Over 40,000 Patients Given Xocova as of April 9: Shionogi
April 18, 2023
- Estimated 37,746 Patients Given Xocova as of March 19: Shionogi
March 29, 2023
- Additional Safety Measures for Xocova “Not Needed at This Time”: MHLW Panel
March 24, 2023
- Serious Side Effect Cases Total 8: Xocova Safety Update
March 13, 2023
- Xocova Taken by Estimated 32,270 Patients as of Feb. 19: Shionogi
February 28, 2023
- MHLW Panel Maintains Caution against Xocova Use in Women Who Might Be Pregnant
February 22, 2023
- Xocova’s Serious Side Effect Cases Total 5: Shionogi
February 13, 2023
- Estimated 21,528 Patients Given Xocova as of Jan. 22: Shionogi
January 30, 2023
- Estimated 11,867 Patients Given Xocova as of Jan. 5: Shionogi
January 16, 2023
- Shionogi Reports 2 Serious Side Effect Cases in Xocova Update
January 6, 2023
- No Add'l Safety Measures for Xocova Needed “at This Time”: MHLW Panel
December 28, 2022
- Estimated 4,640 Patients Took Xocova by Dec. 18: Shionogi
December 27, 2022
- Estimated 1,024 Patients Took Xocova in First 11 Days: Shionogi
December 13, 2022
REGULATORY
- Japan Panel to Review Ferring Gene Therapy, Fujifilm Cell Product on April 20
April 14, 2026
- LDP, Ishin to Explore Role of Private Insurance in Reform Talks
April 14, 2026
- Middle East War Hitting API Air Freight, Trade Group Warns
April 13, 2026
- Japan’s 19th Pharmacopoeia Revision Takes Effect
April 13, 2026
- Voranigo and More Meds Missing from April Listing Slate; Servier Plans Packaging Change
April 10, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…