Biogen Delays US Aducanumab Filing to Q3, but Keeps Japan’s 2020 Plan Intact
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 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
- ViiV to Hone In on Long-Acting Treatments for HIV: Japan President
December 11, 2024
- Ono Set for Japan Filing of SK Bio’s Epilepsy Med in FY2025
December 11, 2024
- It’s High Time to Rethink Market Price-Based Revision Scheme: Chugai CEO
December 10, 2024
- Daiichi Sankyo’s TROP2 ADC Gets Breakthrough Therapy Tag in US
December 10, 2024
- Off-Year Re-Pricing Will Ruin Investment Momentum: BMS Japan Chief
December 10, 2024
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…
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…
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…