For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
BUSINESS
Eisai’s Lecanemab Bags Fast-Track Status in US
Eisai said on December 24 that its anti-amyloid beta (Aβ) protofibril antibody lecanemab being jointly developed with Biogen for early Alzheimer’s disease has earned Fast Track designation from the US FDA. The drug had been granted the Breakthrough Therapy tag…
To read the full story
Related Article
- Eisai CEO Anticipates Leqembi Approval in Europe and China by March
December 18, 2023
- Leqembi to Cost 2.98 Million Yen per Year, Re-Pricing Might Be Triggered on Patient Upswing
December 14, 2023
- Leqembi to Debut on Dec. 20; Eisai Sees SC Version and Blood Biomarker as Drivers for Wider Use
December 14, 2023
- Leqembi OK’ed for Listing on Dec. 20; Peak Sales Put at 98.6 Billion Yen
December 13, 2023
- Chuikyo Agrees to Adopt Normal Rules to Price, Re-Price Leqembi
November 16, 2023
- Industry Prods Careful Debate on Creating Separate Rules for Leqembi Re-Pricing
November 9, 2023
- Medical, Long-Term Care Data Linkage Holds Key to CEA: Leqembi Debate
October 30, 2023
- Leqembi’s Initial Pricing Won’t Factor in Benefits in Long-Term Care
October 19, 2023
- Post-Launch Re-Pricing Likely the Focus of Chuikyo Leqembi Discussions
October 5, 2023
- As Chuikyo Begins Pricing Debate of Leqembi, Panelists Urge Safety, Fair Access
September 28, 2023
- Leqembi Subject to Cost Control Rule for Potential Big Sellers, MHLW Still Set to Meet Listing Deadline
September 26, 2023
- Japan Approves Eisai/Biogen’s Alzheimer’s Drug Leqembi
September 25, 2023
- Eisai’s Alzheimer’s Drug Clears Advisory Panel, Now in Line for Japan Approval
August 22, 2023
- Full US Nod in Hand, Eisai CEO Keeps 1 Trillion Yen Sales Target for FY2030
July 10, 2023
- FDA Awards Full Approval to Eisai’s Alzheimer’s Drug
July 7, 2023
- Eisai’s Leqembi Wins Coverage from US Veteran’s Body
March 15, 2023
- FDA Accepts Eisai’s Lecanemab Application for Early July Target
March 6, 2023
- Lecanemab Earns Priority Review in Japan, Eisai Aims for Approval by Year-End
January 31, 2023
- Lecanemab Application Accepted for Review in Europe; FY2023 Approval Eyed
January 30, 2023
- Alzheimer’s Drug Leqembi Now Available in US: Eisai/Biogen
January 24, 2023
- Alzheimer’s Med Lecanemab Submitted in Japan: Eisai
January 16, 2023
- Eisai Files Alzheimer’s Med Lecanemab in Europe
January 12, 2023
- Leqembi Likely to Hit Peak Sales after 2030, US$26,500 Price Matches Value: Eisai CEO
January 10, 2023
- Lecanemab Nabs Accelerated Approval in US, Set to Hit Market Late January
January 10, 2023
- Eisai Says 2 Trial Deaths Not Attributed to Lecanemab, No Change in Submission Plan
December 1, 2022
- Lecanemab Hits PIII Mark with 27% Cut in Clinical Decline, Eisai Set for Submissions by March-End
September 29, 2022
- Lecanemab Accepted for US Review, Action Date Set for January: Eisai/Biogen
July 7, 2022
- Eisai Completes Rolling Submission for Lecanemab in US
May 11, 2022
- Eisai/Biogen Begin US Rolling Submission for Alzheimer’s Med Lecanemab
September 28, 2021
- BAN2401 Gets FDA’s Breakthrough Therapy Tag: Eisai/Biogen
June 25, 2021
BUSINESS
- AZ, Kyoto University to Study Pharmacovigilance Using RWD
November 5, 2024
- GRP Japan Acquires Hypoglycemia Drug Baqsimi from Lilly
November 5, 2024
- Meiji Seika Pharma “Preparing” to Sue CDP’s Haraguchi
November 5, 2024
- ROS1 Drug Effective in Japanese Subgroup: Nippon Kayaku
November 5, 2024
- Mitsubishi Tanabe Sales Up 6% on Radicava Oral Form
November 5, 2024
Japan introduced a new health coverage scheme for long-listed products (LLPs) on October 1. A survey of generic drug makers…
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…
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…
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…
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…