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…
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- MHLW Pharma Bureau Chief Eager to Do Everything on Regulation Panel’s Agenda
July 25, 2023
- Label Expansions for Jakavi, Soliris in Line for Approval
July 25, 2023
- Panel on Generic Industry to Boot Up July 31, Report Expected by Fall
July 25, 2023
- Label Updated for ViiV’s 4 HIV Meds to Change Caution for Patients with Renal Dysfunctions
July 24, 2023
- 93 Health Damages Reported for Temcell in Japan: October-March
July 24, 2023
- Japan Embassy Granted First In-Person Visit to Detained Astellas Employee
July 24, 2023
- Japan Might See COVID-19 Spike in Summer: Top Govt Spokesman
July 24, 2023
- Tadayuki Mizutani Tapped as MHLW Director for Pharma Industry Promotion
July 24, 2023
- Phase Out or Scrap Inflation Mitigation Measures: CEFP Members
July 21, 2023
- Label Revisions Ordered for Xocova, Mounjaro to Add New ADR Risks
July 21, 2023
- LDP Policy Panel OKs FY2024 Budget Guidelines, Social Security Wording Unchanged
July 20, 2023
- Japan’s 1st Stelara, G-Lasta Biosimilars Nearing Finish Line
July 18, 2023
- Perjeta/Herceptin SC Combo Up for MHLW Panel Review on July 31
July 18, 2023
- Reflect Price and Wage Hikes in FY2024 Budget Guidelines, Lawmakers Urge
July 18, 2023
- Relief Claims OK’ed for 6 More Deaths Possibly Tied to COVID Jabs
July 18, 2023
- Japan Weighs Adoption of EMA Approach for Nitrosamine Impurities Risk Assessment
July 14, 2023
- Japan Govt to Stockpile Xofluza for 1.44 Million People
July 14, 2023
- Chuikyo OKs CEA Organization’s Reform Directions for FY2024
July 13, 2023
- Chuikyo Reps Want More Data from Industry to Review Launch Premiums
July 13, 2023
- Chuikyo Discusses Price Maintenance Premium, Focus Is on Company Criteria
July 13, 2023
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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…
IntroductionCommercial transformation is a top priority for pharma leaders in Japan and rightfully so. In a market with low single…
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…