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REGULATORY
- MHLW to Set AI Limit for Atomoxetine’s Nitrosamine Impurities at 100 ng/Day
September 2, 2024
- Japan Panel OKs BMS ROS1 Inhibitor, Janssen Bispecific, JN.1-Targeted Nuvaxovid
September 2, 2024
- LDP Study Group Mulls Seeking More Budget for Immunoglobulins in FY2025
August 30, 2024
- FY2025 Budget Request Earmarks Funding to Systematize Collection of Drug Supply Info
August 30, 2024
- MHLW Seeks 19.8 Billion Yen for Launch of Pandemic Agency JIHS in April
August 30, 2024
- MHLW Requests Funds for Adding PMDA Reviewers, Subsidizing Advisory Fees in FY2025
August 29, 2024
- MHLW to Seek Nearly 800 Million Yen to Boost New Modalities: FY2025 Budget Request
August 29, 2024
- MHLW’s Tax Reform Request Not Yet Clear, HSC Debate Might Be a Cue
August 29, 2024
- LDP Health Division OKs MHLW’s FY2025 Budget Request
August 29, 2024
- NCGM President to Take Helm of Japan CDC after April Merger
August 29, 2024
- Trintellix, Vtama Get 2-Year Extension of Re-Examination Period
August 29, 2024
- Japan Doles Out Orphan Tags for 10 APIs, Pulls Status for Biogen’s MS Drug
August 29, 2024
- Japan Approves Label Expansions for Alecensa, Nucala and More
August 29, 2024
- Panel Conditionally OKs Change to Allow Use of Abortion Pill at Clinics Without Beds
August 28, 2024
- Japan Panel Clears Amgen’s TED Med, Rexulti for Alzheimer’s Agitation and More
August 28, 2024
- High-Dose Mecobalamin Now in Line to Become Japan’s 1st ALS Med in 9-Plus Years
August 28, 2024
- MHLW Sets Global Health Vision to Enhance Drug Innovation Ecosystem
August 28, 2024
- Sakigake Tags Granted to GSK’s Bepirovirsen, Boehringer’s Nerandomilast
August 28, 2024
- MHLW to Address Drug Loss, Generic Industry Reform in FY2025 Budget Request
August 26, 2024
- Astellas Pharma Employee Indicted in China
August 23, 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…