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REGULATORY
- MHLW Plans Disposal of COVID-19 Antibody Meds in Government Stock
July 26, 2024
- HeartSheet’s Conditional Approval to Be Withdrawn as Early as August
July 26, 2024
- LDP Policy Panel OKs FY2025 Budget Guidelines, Lower Cap Likely for “Natural Increase”
July 24, 2024
- Health Minister Hopes to Tap US Insights to Foster Japan Ecosystem
July 24, 2024
- MHLW Seeks Input to Gird for Summer Outbreaks, FPMAJ Ready to Ask for Ramp-Up
July 23, 2024
- Japan’s Fall-Winter COVID Vaccinations Likely to Start from October
July 23, 2024
- MHLW Panel to Review Takeda’s Fruzaqla on Aug. 2; Truvada, Keytruda, Prevenar 20 on Roster Too
July 22, 2024
- MHLW Sets Exceptions to All-Case PMS through Revised Q&A
July 22, 2024
- Japan Panel Says No to Full Approval of HeartSheet, Clears Breyanzi’s Broader Label
July 22, 2024
- Japan Panel Discusses Details of NIP for Shingles Jabs, OKs Inclusion of Prevenar 20
July 19, 2024
- Lilly’s Alzheimer’s Med Up for Health Ministry Panel Review on August 1
July 19, 2024
- MHLW Pharma Management Director Hints at Addressing “Zero” Premium Issue
July 19, 2024
- Chuikyo OKs Plan for Drug Price Survey in FY2024
July 18, 2024
- Debates on FY2025 Off-Year Price Revision Officially Set Sail at Chuikyo
July 18, 2024
- Label Revisions Ordered for Opdivo, Yervoy, Duvroq, and More
July 18, 2024
- LDP Lawmakers Call for Expanded Budget for Pharma Innovation, Stable Supplies
July 18, 2024
- MHLW Clarifies Criteria for “Medical Necessity” of LLPs before Elective Care Rollout
July 17, 2024
- Pharma Innovation, Supply Raised as Key Topics for FY2025 Budget: LDP Confab
July 10, 2024
- Japan Wants to Spur Regulatory Use of RWD, but Still Puts Weight on RCTs
July 10, 2024
- Ex-Health Minister Otsuji to Retire from Politics Next Summer
July 10, 2024
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Earlier this month, Health Minister Keizo Takemi called on the top executives of 13 major generic makers to restructure the industry with a product consolidation target of “around five companies per API.” While a variety of restructuring options are conceivable,…
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…
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…