Long-listed products (LLPs) in Japan will be subject to a new health coverage scheme starting this October. This is expected…
REGULATORY
Japan Panel OKs Novartis’ siRNA Dyslipidemia Therapy and More
A Japanese health ministry panel on August 21 backed regulatory approval for a throng of new medicines, including Novartis Pharma’s inclisiran, which would become the first siRNA therapy for dyslipidemia in the country, if approved. Inclisiran, marketed as Leqvio in…
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
- Phesgo, Epkinly, Leqvio Hit Japan Market, Wegovy Launch Set for Feb. 22
November 24, 2023
- Chuikyo Agrees to Adopt Normal Rules to Price, Re-Price Leqembi
November 16, 2023
- Listing OK’ed for Phesgo, Leqvio, Epkinly, and More; 30 Billion-Plus Yen Peak Sales for 3 Meds
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
- Japan Approves Multiple Firsts, Leqembi, Arexvy, Leqvio, and More
September 26, 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
REGULATORY
- Panelists See Legal Issue over Providers’ Refusal of People Vaccinated with Replicon Shot
September 20, 2024
- MHLW to Update Decade-Old Generic Roadmap, Add Blueprint for Biosimilars
September 20, 2024
- Japan Panel OKs 5 COVID Vaccines for NIP Use from October
September 20, 2024
- Puberulic Acid Determined as Cause of “Beni-Koji” Health Damages
September 19, 2024
- MHLW Working Group Gets into Details of Proposed Drug Supply Info System
September 18, 2024
In the Western world, LinkedIn is a staple for many recruitment professionals. It has proven to be a powerful tool for networking, talent sourcing and job postings. But in Japan, people don’t use LinkedIn very much.Here’s why LinkedIn isn’t popular…
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…