The number of new graduates hired for sales rep roles increased in FY2025 after declining for five consecutive years, a…
BUSINESS
In Shocking U-Turn, Biogen/Eisai Say to File Aducanumab in Early Next Year
In a surprising reversal, Biogen and partner Eisai said on October 22 that they are planning for a regulatory filing for aducanumab - their much-hyped Alzheimer’s drug that was thought to have been ditched after PIII failures earlier this year…
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
- 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
- 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
- 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
- Will Japan Reinstate Sakigake Status for Aducanumab? Many See It Unlikely
November 15, 2019
- Eisai CEO Says Aducanumab Resurrection Was a Surprise, Touts Totality of Data as He Relays New Findings
October 31, 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
- US Remains Key Market for Daiichi Sankyo: CEO
May 13, 2025
- Daiichi Sankyo Pushes Global HR Revamp, Adopts Job-Based Scheme
May 13, 2025
- Shionogi Nets Record Earnings for 3rd Consecutive Year on Overseas Expansion
May 13, 2025
- Toho Launches Specialty Drug Home Delivery Service with Vyvdura
May 13, 2025
- Bayer Files Eylea 8 mg for Macular Edema following RVO in Japan
May 13, 2025
The traditional HR Business Partner (HRBP) model, once the gold standard for HR delivery, is undergoing a significant transformation. Many organizations, particularly in industries like pharmaceuticals, are moving towards a more agile resource model, aiming to streamline HR operations and…
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 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…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
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…