Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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REGULATORY New ICH Topic on RWD to Be Proposed towards Its Use in Regulatory Review
July 2, 2024
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REGULATORY PMDA Opens 1st Overseas Office in Bangkok
July 2, 2024
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BUSINESS Eisai to Go Solo on Its 1st ADC after BMS Exits Deal
July 2, 2024
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BUSINESS Pfizer Files Hemophilia B Gene Therapy in Japan
July 1, 2024
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REGULATORY MHLW Sets Up Global Strategy HQ to Bolster Innovation Ecosystem
June 28, 2024
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BUSINESS Sumitomo Resolved to Revive Business, Optimize Japan Organization: New CEO
June 27, 2024
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BUSINESS Finnish Pharma Orion Poised for Japan Debut with Reacquisition of Parkinson’s Meds This Year
June 26, 2024
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BUSINESS BMS Gears Up for Return to Neuroscience with KarXT, Explores Path toward Japan Rollout Too
June 25, 2024
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REGULATORY Japan OKs Honebuto Paper, Modest Wording on Off-Year Revisions Finalized
June 24, 2024
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ACADEMIA Academic Society Frets Availability of 1st-Gen Oral Cephems amid Choseido Halt
June 24, 2024
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REGULATORY Japan to Obligate Single IRB in Multi-Center Clinical Trials That Use Competitive Funds
June 24, 2024
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BUSINESS Axcelead’s Next CEO Eyes Sales of 120 Billion Yen, Ramp-Up in Mega Pharma Orders
June 21, 2024
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BUSINESS SanBio Says Its Lead Cell Therapy Could Be Shipped from 2025 If All Goes Well
June 21, 2024
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BUSINESS Gilead Eager to See More Authorized CAR-T Treatment Centers in Japan
June 21, 2024
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BUSINESS Tsumura Looks to Plant “Guidepost” for Development of Botanical Drugs in US
June 20, 2024
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REGULATORY SanBio’s Lead Cell Therapy in Line for Conditional Nod but Can’t Be Shipped Until Comparability Is Confirmed
June 20, 2024
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BUSINESS Concerns Grow over Supply of Cephem Antibiotics after Choseido Plant Halt
June 19, 2024
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REGULATORY LDP Tweaks Honebuto Text on Off-Year Revision, Waters Down Push for CEA Expansion
June 18, 2024
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BUSINESS Kunio Takeda, Former CEO of Takeda Pharmaceutical, Dies at 84
June 18, 2024
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BUSINESS India’s Biocon to Set Up Japan Office to Make Full Inroads into Generic API Sector
June 18, 2024
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Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…