For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
REGULATORY
No Add'l Safety Measures for Xocova Needed “at This Time”: MHLW Panel
Additional safety measures are “unnecessary” at the present time for Shionogi’s COVID-19 treatment Xocova (ensitrelvir), which was granted Japan’s first emergency approval, a health ministry panel agreed on December 27 based on its review of adverse event reports. The first…
To read the full story
Related Article
- Xocova Given to Over 50,000 Patients in 6 Months: Shionogi
June 6, 2023
- No Additional Safety Measures Needed at this Time for Xocova: Panel
May 11, 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
- Japan to Revise Revlimid Risk Management Rule in June; February Generic Approval Eyed
January 25, 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
- 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
- MOF Panel Urges Annual Price Revisions on All Drugs in 2025 Budget Proposal
November 29, 2024
- Japan to Require Drug Makers to Set Up Legal Post of “Stable Supply Manager”
November 29, 2024
- Japan Set to Put Up 100 Billion Yen to Support Pharma under Economic Package
November 29, 2024
- Orphan Tag Given to Renalys’ IgA Nephropathy Therapy and 13 More Drugs
November 29, 2024
- Scrap Off-Year Price Revisions, Smaller Japan Firms Face Uphill Battle: DPP Exec
November 28, 2024
Earlier this month, the Ministry of Finance (MOF) unveiled a long list of social security proposals towards the FY2025 budgeting,…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…