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REGULATORY
- Xocova Approval Meaningful, but Careful Use Should Continue: Minister
March 6, 2024
- Opdivo Faces 15% Slash in Spillover, Re-Pricing to Hit 23 Drugs in FY2024 Revision
March 5, 2024
- Drug Prices Cut by 4.67% in FY2024 Revision, 314 APIs to Keep Full Prices with PMP
March 5, 2024
- Shionogi’s COVID Pill Xocova Lands Standard Approval in Japan
March 5, 2024
- Japan Panel Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
March 5, 2024
- MHLW to Ask All Generic Makers in Japan to Execute Self-Inspections
March 4, 2024
- Japan’s Revised Drug Distribution Guidelines Take Effect
March 4, 2024
- PMDA Reviewing Safety Risks for 4 CAR-T Therapies and More
March 4, 2024
- Generic Mergers, Product Consolidations Unlikely to Pose Antitrust Issue: FTC Official
March 1, 2024
- Chugai’s PNH Med, Takeda’s cTTP Therapy Now in Line for Japan Approval
March 1, 2024
- Hospitals, Pharmacies Must Also Join Effort in Improving Drug Distribution: Expert Panel Member
February 29, 2024
- MHLW Sets Out to Beef Up Inspector Skills with Nationwide Sharing of GMP Reports
February 29, 2024
- Health Minister Reaffirms April Start of New Drug Shortage Reporting Scheme
February 28, 2024
- MHLW Panel Endorses Lowe Syndrome as Designated Intractable Disease
February 28, 2024
- NCC to Add Cabozantinib, Valemetostat to Pediatric, AYA Cancer Trial
February 27, 2024
- Show Change in Development Trends before Seeking 2026 Reform: MHLW to Pharma
February 27, 2024
- Japan Panel Backs Approval of Takeda’s Acquired Hemophilia A Drug
February 26, 2024
- Drug Comparisons in Promotional Activities Allowed under 4 Conditions: MHLW
February 26, 2024
- Deduction Formula for IP Box Tax Relief Now Clear as Preparations Move Ahead
February 22, 2024
- LDP Panel OKs Bill to Amend Regenerative Medicine Safety Act, but Lawmakers Fret Lack of Ban on “Designer Babies”
February 22, 2024
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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…