Japan’s health ministry approved a slew of new medicines on September 25 including multiple “first of its kind” products, among them being GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine Arexvy as well as Eisai’s Alzheimer’s therapy Leqembi (lecanemab).Arexvy became the first…
HOME > REGULATORY
REGULATORY
- MHLW Panel OKs Inclusion of 5-in-1 Vaccine in National Immunization Program
August 30, 2023
- Label Revisions Ordered for CAR-T Therapies on Out-of-Spec Products
August 30, 2023
- Japan Panel Clears GSK’s Arexvy, 1st RSV Vaccine, for Approval
August 29, 2023
- Kazunari Asanuma to Lead MHLW Health Policy Bureau
August 29, 2023
- MHLW to Seek Funds for Survey to Streamline Generic Manufacturing: FY2024 Request
August 28, 2023
- MHLW to Book Budget to Launch Regulatory Advisory Center for Pediatric, Orphan Meds for FY2024
August 28, 2023
- MHLW to Seek 33.7 Trillion Yen Budget for FY2024
August 28, 2023
- Japan to Shell Out Up to 30 Billion Yen for National Project to Spur Dementia R&D
August 28, 2023
- Shunichi Kuryu to Take Helm at New Infectious Disease Agency
August 28, 2023
- MHLW Eyes Pediatric, Orphan Drug Advisory Team within PMDA: FY2024 Budget Request
August 25, 2023
- Japan Grants Orphan Tag to Efzofitimod, 3 More APIs
August 25, 2023
- Drug Pricing Organization Proposes Changes in PMP, Re-Pricing Criteria towards 2024 Reform
August 24, 2023
- Chuikyo OKs Listing of Litfulo and More; 10 Billion-Plus Yen Peak Sales for Pfizer, Sobi Meds
August 24, 2023
- Lyfnua to Get 7.7% Price Cut in November, Retevmo Analysis Results Reported: CEA
August 24, 2023
- Luxturna Priced at 49.6 Million Yen per Vial, Peak Sales Put at 500 Million Yen with 5 Patients
August 24, 2023
- Hemlibra, Lynparza, Zejula Face Quarterly Re-Pricing, 7.7-10.2% Cut in November
August 24, 2023
- Japan Approves Enhertu’s NSCLC Use, More Label Expansions
August 24, 2023
- Novo’s Obesity Med Wegovy Skips Listing Again in August
August 24, 2023
- Japan Designates Loxoprofen Cold Meds as Behind the Counter Drugs
August 23, 2023
- Japan Looks to Launch Innovation Tax Incentive to Ramp Up R&D Investments
August 23, 2023
ページ
“Time is the scarcest resource, and unless it is managed, nothing else can be managed.” - Peter DruckerSearching for the right candidate takes time… but how much time?The last thing you want is to waste time searching for the wrong…
A doctor member of the Central Social Insurance Medical Council (Chuikyo) on September 20 traded barbs with pharma leaders over…
The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…
The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies…
In the run-up to FY2024 budget requests this summer, there were growing hopes in the pharmaceutical industry that the government's de-facto cap on increases in social security spending would finally be lifted. That did not happen, despite strong calls from…
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…