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REGULATORY
- Japan’s 1st Eylea Biosimilar Approval on Horizon? JAN Now Decided
March 25, 2024
- Chuikyo Agrees to Exempt PD-1/PD-L1, JAK Classes from Spillover Re-Pricing
March 25, 2024
- Xocova’s Price to Remain Intact after Full Approval, No Change in Clinical Positioning
March 25, 2024
- Japan Set to Push Central IRBs for Clinical Trials, Avoid Customary All-Case PMS
March 22, 2024
- Pharma Regulation Panel Wraps Up Debate, Report to Be Finalized Soon
March 22, 2024
- 1 Year on, China Mulling Potential Indictment of Detained Astellas Employee
March 22, 2024
- Japan Awards Orphan Tag to Janssen’s Talquetamab, 2 More APIs
March 22, 2024
- Japan Resumes Debate on Rx-to-OTC Switch of PPIs after Over 5 Years
March 22, 2024
- New LDP Project Team Launched to Boost Global Access to Infectious Disease Drugs
March 21, 2024
- Industry Explains Scheme to Deal with New Self-Inspection Asked for All Generic Makers
March 19, 2024
- Japan Mulls Simplifying Drug Delisting Process to Help Ensure Stable Supplies
March 19, 2024
- Japan to Work towards Ensuring Consistency in Different Clinical Trial Laws
March 19, 2024
- Japan Panel to Discuss Fate of SanBio’s Sakigake Cell Therapy amid Stalled Review
March 19, 2024
- Japan to Cap COVID Vaccine Copay at 7,000 Yen under NIP
March 18, 2024
- Japan to Present Class-by-Class Generic Shares to Hit New Goals: Minister
March 18, 2024
- Another Daiichi Sankyo Veteran to Take Over as Provost of SCARDA
March 15, 2024
- Japan Begins Discussions on RSV Vaccines for National Immunization Program
March 15, 2024
- Japan to Set Value-Based Share of 65% as Secondary Target for Generic Use
March 15, 2024
- Xocova Set for Renewed Price-Setting after Full Approval, Big Cut Unlikely
March 14, 2024
- PD-1/PD-L1, JAK Drugs to Be Exempt from Spillover Price Cuts: Chuikyo
March 14, 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…