The Ministry of Health, Labor and Welfare (MHLW) on November 29 proposed a more stringent application of the current 40% entry price rule for first oral generics towards the FY2024 drug pricing reform.Under the current rule, first oral generics are…
BUSINESS
Aducanumab Termination Was Wrenching Decision: Eisai CEO
Eisai CEO Haruo Naito said on April 23 that calling off key PIII programs on the Alzheimer’s drug candidate aducanumab was a “wrenching decision” to make for his company and its partner Biogen, offering apologies at the Japanese drug major’s…
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 Expects “Billions of Dollars” from New Alzheimer’s Drug
June 15, 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
- 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/Eisai’s Aducanumab Fails, Dashing Hopes in Alzheimer’s Field
March 22, 2019
BUSINESS
- Abecma Approved for Earlier Lines of MM Therapy in Japan: BMS
December 7, 2023
- Pfizer to Cut Ties with 3 Regional Wholesalers, Further Narrowing Expected
December 5, 2023
- Shionogi Hooks Up with Life Science VC AN Venture Partners
December 5, 2023
- Preliminary Injunction for Sprycel Generic “Extremely Unjust”: Sawai
December 5, 2023
- Ono Doubles Investment in Corporate Venture Fund to US$200 Million
December 4, 2023
Referrals can be an absolute game-changer in recruitment.When someone in your network recommends a candidate, they often have firsthand insight into the person’s skills, work ethic, values and ambitions. This insider knowledge results in higher quality candidates who are a…
Chugai Pharmaceutical’s Phesgo (pertuzumab + trastuzumab + vorhyaluronidase alfa) and Novartis’ Leqvio (inclisiran) will be newly added to the Japanese reimbursement list along with a batch of other medicines on November 22. Three drugs carry peak sales outlooks of over…
The main players in the FY2024 reimbursement policy reform are now all in place, with the roster rounded out by the appointment of former health minister Katsunobu Kato for the Liberal Democratic Party’s (LDP) prominent social security post at the…
A member of the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry on November 13…
A health ministry study group on pharmaceutical regulations on October 13 roughly agreed on a reform plan for Japanese regulatory…
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…