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REGULATORY
- Medipharma Altered Data in at Least 7 Clinical Trials: MHLW
November 28, 2023
- Meiji’s mRNA Vaccine, Pfizer’s RSV Vaccine Now in Line for Approval
November 28, 2023
- Chuikyo Supports Adding More Dosage Forms to “Minimum Price” Category, Urges Improvements in Distribution Practices
November 27, 2023
- HCPs, Payers Spat over Extension of Add-On Fee Premiums Related to Drug Supply Issues
November 27, 2023
- As Leqembi Listing Approaches, Chuikyo OKs Coverage for PET Device and Diagnostics
November 27, 2023
- Ultragenyx’s Evinacumab, Alexion’s Danicopan Up for Japan Panel Review on Dec. 8
November 27, 2023
- Pool Fever Reaches Alert Level in Japan for 1st Time in Decade: NIID
November 27, 2023
- Japan Deeping Debate on LLP Copay Review; Focus Is on Exclusion Criteria, Payment Levels, G1/G2 Rule Change
November 27, 2023
- Japan Approves Label Expansions for Opdivo, Adcetris, and More
November 27, 2023
- Japan Grants Orphan Tags to MSD’s MK-3475A, 3 More Drugs
November 27, 2023
- COVID Vaccines to Join NIP for Ages 65-Plus from April, with Copay Required
November 24, 2023
- No Objections to Better Premiums, Easing of Re-Pricing as Incentives for Pediatric Drug Development: Chuikyo
November 24, 2023
- Chuikyo Reps Split on Nixing PMP Company Criteria; Many Back Review of Reduction Caps under Re-Pricing
November 24, 2023
- MHLW Proposes Posting Reported Drug Supply Concerns on Its Website
November 22, 2023
- Label Revisions Ordered for 5 Anticoagulants Agents
November 22, 2023
- LDP Health Division Head Calls for “Innovation Box” Tax Break: Hearing
November 22, 2023
- Chuikyo Offers No Objection to MHLW Proposal on SaMD Reimbursement Criteria
November 21, 2023
- MHLW Notification Outlines 2-Stage Approval Scheme for SaMD
November 21, 2023
- Provide “One-Stop Services” to Facilitate Multiregional Clinical Trials: Expert
November 21, 2023
- 1st G-Lasta Biosimilar Gets Japan Listing, Stelara Follow-On Not on Roster
November 21, 2023
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For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
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…