In a recent conversation with James Feliciano, former president of AbbVie Japan, we delved into the intricacies of leadership in the Japanese pharmaceutical industry. Feliciano, a seasoned industry veteran, shared valuable insights into his experiences, challenges, and successes.Navigating the Abbott…
BUSINESS
Biogen Files Japan NDA for Aducanumab
Biogen has filed a new drug application for its Alzheimer’s treatment aducanumab in Japan, the third market where the drug has been submitted for regulatory approval, after the US and Europe, the big biotech and partner Eisai said. “Japan has…
To read the full story
Related Article
- Biogen Pulls EU Application for Aduhelm
April 25, 2022
- 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
- Japan Seeks Additional Study for Aducanumab, Next Review Might Be Few Years Off
December 23, 2021
- Biogen Halves US Price Tag on Aduhelm to Improve Patient Access
December 21, 2021
- Biogen to Challenge European Rejection of Aducanumab
December 20, 2021
- Aducanumab Gets “Negative Trend Vote” in Europe: Biogen/Eisai
November 18, 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
- Expert Panel Delivers Harsh Verdict on Aducanumab, FDA Decision Due by March 7
November 9, 2020
- European Regulators Accept Aducanumab for Review: Biogen/Eisai
November 2, 2020
- Aducanumab Filed in Europe: Biogen/Eisai
October 22, 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
BUSINESS
- Nippon Shinyaku’s Viltepso Patents Invalid: US Jury Verdict
December 24, 2024
- Increased Off-Year Pressure on LLPs Would Only Exacerbate Supply Crunch: Industry Officials
December 24, 2024
- Eisai/Fujirebio Tie Up in Biomarker Research for Neurodegenerative Diseases
December 24, 2024
- Orion Now MA Holder of Parkinson’s Meds Stalevo, Comtan in Japan
December 24, 2024
- Shionogi to Take Full Control of 2 China Joint Ventures
December 24, 2024
The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…
Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving the…
Will an “off-year” drug price revision happen in April 2025 or not? Over the last week, expectations have been up…
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…
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…