Discussions by the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry structure are reaching the last lap. Its final report - a draft of which will be presented later this month - is expected to…
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REGULATORY
- Japan’s First Guidance for Development of Cancer Immunotherapies Will Promote Development
February 13, 2017
- Drugs Subject to Optimal Use Guidelines Will Be a Rarity: Mori
February 13, 2017
- MHLW Weighs Use of Medical Bill Database for 4 Times Yearly Price Review: Nakayama
February 10, 2017
- MHLW Councilor Cites Cancer Meds for Conditional Early Approval Scheme
February 10, 2017
- MHLW Advisory Committee Backs Shionogi’s OIC Drug
February 10, 2017
- Post-Marketing Conditions Under “Conditional Early Approval System” Remain Unclear: MHLW Councilor Kazuhiko Mori
February 10, 2017
- 2nd Batch of Sakigake Designation Slated for Spring
February 9, 2017
- Chuikyo Panel to Draw Conclusion by Summer for FY2018 Rollout of Cost-Effective Assessment Scheme
February 9, 2017
- Bill Payers, Doctors in Skirmish over Drug Price Survey for Gap-Year Revisions: Chuikyo
February 9, 2017
- Chuikyo OKs Optimal Use Guidelines for Opdivo and Keytruda, Due Out Feb. 14
February 9, 2017
- PMDA to Delay Planned Staff Increase for Financial Reasons, Pace of Increase Has Slowed Down
February 9, 2017
- Keytruda Gets Same Daily Price as Opdivo; Chuikyo OKs Batch of Drugs for Feb. 15 Listing
February 8, 2017
- MHLW Notifies of Package Insert Changes for Iguratimod
February 8, 2017
- Sanofi’s VEGF Inhibitor Clears MHLW Advisory Panel for Colorectal Cancer
February 6, 2017
- MHLW Will Strictly Respond to Violations, Shiozaki Says on Fake Harvoni Issue
February 6, 2017
- MHLW Wraps Up Probe into Fake Harvoni after Distribution Routes “Most Likely” Identified
February 2, 2017
- MHLW to Set Up Committee on Pharmaceutical and Medical Device Regulation at Health Sciences Council
February 2, 2017
- MHLW to Actively Recommend Japanese Encephalitis Vaccine for Children Turning 18
February 2, 2017
- MHLW Pins Down Distribution Routes for Harvoni Counterfeits; Composition of Fake Pills Identified
February 1, 2017
- MHLW, Pharma Industry Officials Agree on Conditional Early Approval System
January 31, 2017
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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…