Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
REGULATORY
Panel Confirms Backing for Alexion’s Bleeding Antidote after Data Integrity Issues
Alexion Pharmaceuticals’ andexanet alfa, an antidote for factor Xa inhibitors, cleared a key health ministry panel on March 9 by clinching the confirmation of its support for approval after the review process was paused due to a possible data integrity…
To read the full story
Related Article
- Japan Approves Kerendia, Vabysmo, Ondexxya, Takhzyro and More
March 29, 2022
- Alexion’s Bleeding Antidote to Be Approved as Early as This Month
March 24, 2022
- Japan Approves Array of Fertility Treatments ahead of Coverage Rollout
March 16, 2022
- Alexion’s Bleeding Antidote Up for PAFSC Discussion Again after Data Integrity Issues
March 3, 2022
- Fertility Treatment Indications for 9 Meds to Be Reported to PAFSC Panel on March 9
February 25, 2022
- Data Integrity Risk Detected for Alexion’s Approval-Pending Bleeding Antidote, Report to Panel Put on Hold
September 24, 2021
- MHLW Panel Shelves Decision on Entresto’s Hypertension Use, Clears Otsuka’s Eczema Med and More
August 31, 2021
REGULATORY
- Pharma Renews Call for Abolishing Off-Year Revisions, but MHLW Stays Put with Honebuto
November 22, 2024
- Pharma Pushes to Scrap Off-Year Revisions; LDP Members Urge Fresh Talks by 4 Ministers
November 22, 2024
- Health Minister Committed to Drug Supplies, Repeats Plan to Base Off-Year Debate on Honebuto
November 21, 2024
- DPP Requests Promotion Self-Medication Tax Break in 3-Way Talks
November 21, 2024
- 3 Parties Reach Deal on Economic Plan, Off-Year “Abolition” Not Spelled Out
November 21, 2024
For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
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…