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REGULATORY
- PMDA Reviewing Safety Risks for Opdivo, Yervoy
May 22, 2023
- Novo Mum over Pass on Wegovy Listing in May
May 19, 2023
- Japan Eyes Pilot Program for OTC-Switching of Emergency Contraceptives, Public Commenters Overwhelmingly Positive
May 18, 2023
- LDP Committee Calls for Setting Up Asian Hub of PMDA
May 18, 2023
- Industry Associations Stress Special Cost Structure of SaMD in Chuikyo Hearing
May 18, 2023
- Market Expansion Re-Pricing to Hit Tarlige, Entresto, Verzenio; Spillover to 2 Other Meds
May 18, 2023
- Deregulation Panel Eyes Use of Medical Data “Without Patient Consent”
May 17, 2023
- LDP Project Team to Finalize Pharma Policy Proposal for Honebuto by May-End, Submit It to Prime Minister
May 17, 2023
- Create Command Tower to Integrate Innovation Support and Drug Pricing Policy: LDP Project Chief
May 17, 2023
- Chuikyo OKs Listing of Omvoh, Entyvio SC, Besremi, and More; Biggest Sales Outlook for Lilly Drug
May 17, 2023
- Novo’s Obesity Drug Wegovy Skips May Listing, Sobi’s Empaveli Too
May 17, 2023
- Cancer Meds from Servier, Taiho, Pfizer’s AA Drug Up for Panel Review on May 29
May 16, 2023
- MHLW Issues ICH E19-Based Guideline on Selective Approach to Safety Data Collection in Clinical Trials
May 16, 2023
- 68.3% of Public Comments Supported Mefeego Approval: MHLW
May 16, 2023
- G7 Health Chiefs Vow to Spur Antibiotic and Dementia Drug Development, Access to Vaccines
May 15, 2023
- Gene Therapy Luxturna Up for MHLW Panel Review on May 26
May 15, 2023
- Komeito Lawmakers Propose Review of Off-Year Re-Pricing, Correction of Multi-Product Small-Lot Generic Production
May 12, 2023
- MOF Continues to See Macroeconomic Indexing Reasonable: Panel Meeting
May 12, 2023
- LDP Pharma Study Group Eyes Removal of Budget Cap on Social Security Spending
May 11, 2023
- Nonpartisan Lawmaker League OKs Dementia Bill, Eyes Enactment in Current Diet
May 11, 2023
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Chugai Pharmaceutical’s Phesgo (pertuzumab + trastuzumab + vorhyaluronidase alfa) and Novartis’ Leqvio (inclisiran) will be newly added to the Japanese reimbursement list along with a batch of other medicines on November 22. Three drugs carry peak sales outlooks of over…
The main players in the FY2024 reimbursement policy reform are now all in place, with the roster rounded out by the appointment of former health minister Katsunobu Kato for the Liberal Democratic Party’s (LDP) prominent social security post at the…
A member of the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry on November 13…
Many members of a key reimbursement policy panel on November 10 called on the health ministry to revisit the current listing requirement of at least 25 years for the designation of essential medicines now that annual revisions have been introduced…
A health ministry study group on pharmaceutical regulations on October 13 roughly agreed on a reform plan for Japanese regulatory…
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…