Japan introduced a new health coverage scheme for long-listed products (LLPs) on October 1. A survey of generic drug makers…
REGULATORY
Gene Therapy Luxturna Now in Line for Approval in June
Novartis’ gene therapy for inherited retinal disease LTW888, known as Luxturna overseas, sailed through a review by a key health ministry advisory committee on May 26, with the panel’s nod setting the stage for its approval as early as June.…
To read the full story
Related Article
- Novartis Rolls Out Luxturna in Japan, 2 Treatment Facilities Selected
August 31, 2023
- Luxturna Priced at 49.6 Million Yen per Vial, Peak Sales Put at 500 Million Yen with 5 Patients
August 24, 2023
- Drug Pricing Rules to Be Applied to Novartis’ Gene Therapy Luxturna
July 6, 2023
- Japan Approves Novartis’ Gene Therapy Luxturna for Rare Eye Disease
June 27, 2023
REGULATORY
- Supply of Anapeine Generic to Start by Year-End: Minister
October 9, 2024
- MHLW Issues Notification to Spur Use of RWD in Place of Clinical Trial Data
October 7, 2024
- New Health Minister to Stick to Honebuto Text on Off-Year Plan
October 7, 2024
- Ishiba Makes No Mention on Pharma in First Policy Speech
October 7, 2024
- Komeito’s Yoko Wanibuchi Newly Named Senior Vice Health Minister
October 4, 2024
It’s easy to spot motivated and engaged employees. They are more productive, they go the extra mile, and they display a sense of ownership in their work.But how do you replicate this culture throughout your organization? How do you encourage…
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…