Japan plans to revise its definition of “vaccines of high development priority.” The Ministry of Health, Labor and Welfare’s (MHLW)…
REGULATORY
Japan Seeks Additional Study for Aducanumab, Next Review Might Be Few Years Off
A key Japanese health ministry committee on December 22 held off its decision on Biogen/Eisai’s Alzheimer’s drug aducanumab, concluding it is difficult to judge its efficacy with the mixed trial results submitted and is seeking data from an additional study.…
To read the full story
Related Article
- CMS Decision De-Facto Denial of All Medicare Patient Access to Aduhelm: Biogen
April 11, 2022
- Aduhelm Deal Revised, Eisai Poised to Sharpen Focus on Lecanemab: CEO
March 17, 2022
- Biogen/Eisai Alzheimer’s Pact Amended to Switch Aducanumab Collab to Royalty Scheme
March 16, 2022
- Eisai Formally Opposes CMS Coverage Proposal for Aduhelm
February 14, 2022
- Eisai “Strongly Opposes” Medicare Coverage Proposal for Aduhelm, Calls for Revisit
January 14, 2022
- Biogen Halves US Price Tag on Aduhelm to Improve Patient Access
December 21, 2021
- Biogen/Eisai to Begin Aduhelm Confirmatory Study Next Year
December 17, 2021
- FDA Updates Aduhelm Label to Only Cover MCI, Mild Alzheimer’s
July 9, 2021
- Eisai CEO Says Aducanumab Price Tag Reflects Its Value, 1 Million Patients Estimated in Japan
June 10, 2021
- Aducanumab Gets Accelerated OK, Expert Says FDA Verdict Would Affect Japan Review Too
June 9, 2021
- FDA Approves Aducanumab, 1st Disease-Modifying Therapy for Alzheimer’s
June 8, 2021
- FDA Delays Decision for Biogen’s Aducanumab to June 7
February 1, 2021
- Potential Reimbursement Challenges of Aducanumab Could Usher in Health Insurance Overhaul in Japan
January 8, 2021
- Aducanumab Submitted in Japan, but Decision Unlikely to Come Until Next Autumn
December 11, 2020
- Biogen Files Japan NDA for Aducanumab
December 10, 2020
- Expert Panel Delivers Harsh Verdict on Aducanumab, FDA Decision Due by March 7
November 9, 2020
- Aducanumab Accepted for FDA Review with Priority Tag; Target Date Set for March 7
August 11, 2020
- Aducanumab Filing Completed in US; Talks with Japan/EU Regulators Ongoing
July 9, 2020
- Biogen Delays US Aducanumab Filing to Q3, but Keeps Japan’s 2020 Plan Intact
April 24, 2020
- Biogen Eyes 2020 Aducanumab Filing in Japan Too, Nailing Down Re-Dosing Study Details
December 19, 2019
- Eisai CEO Says Aducanumab Resurrection Was a Surprise, Touts Totality of Data as He Relays New Findings
October 31, 2019
- In Shocking U-Turn, Biogen/Eisai Say to File Aducanumab in Early Next Year
October 23, 2019
- Biogen to Leverage Aducanumab Learnings, Spinraza to Remain Foundation of SMA Care: Japan Chief
June 3, 2019
- Aducanumab Termination Was Wrenching Decision: Eisai CEO
April 24, 2019
- Biogen/Eisai’s Aducanumab Fails, Dashing Hopes in Alzheimer’s Field
March 22, 2019
REGULATORY
- FPMAJ Reports Detailed Results of Blanket Self-Inspections for Generic Firms
January 29, 2025
- Celltrion Is Developer of Japan’s Third Stelara Biosimilar in the Wings
January 29, 2025
- MHLW Donates Mpox Vaccine to Congo
January 28, 2025
- LDP-OK’ed Bill for PMD Act Amendment Specifies Launch of Innovative Drug Fund
January 28, 2025
- Opposition Party Member Calls for Chuikyo Reform
January 27, 2025
As CEO of Morunda, I had the privilege of interviewing Bill Schuster, Country Manager of Viatris in South Korea. Our conversation delved into the multifaceted nature of leadership in the healthcare industry, exploring challenges, successes, and the power of authenticity.A…
A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
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…
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…