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TOP STORIES
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REGULATORY MHLW to Issue Basic Guide to PMS for Conditional Early Approval: Drug Review Chief
October 11, 2017
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REGULATORY Japan Needs “Quick and Low-Cost” R&D Setup: Top MD Bureaucrat
October 10, 2017
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REGULATORY MHLW to Place Priority on “Mutual Understanding” with Industry: Economic Affairs Chief
October 6, 2017
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REGULATORY Payers Oppose Price Hikes based on CEA at 1st Joint Meeting: Chuikyo
October 5, 2017
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BUSINESS Japan Debut of MSD’s Zetia/Lipitor Combo Delayed as Cyberattack Woes Continue
October 4, 2017
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REGULATORY MHLW Wants to Introduce Conditional Early Approval System This Month: Minister
October 3, 2017
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REGULATORY (Update) Bayer Told to Improve Practice over ADR Reporting Delays, Gets “Verbal Guidance” for Xarelto Survey Fuss
October 2, 2017
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REGULATORY MHLW Unveils Planned Framework for Conditional Early Approval Scheme
September 29, 2017
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REGULATORY MHLW OKs Japan’s 1st PD-L1 Inhibitor, 8-Week Hep C Med, Ibrance and More
September 28, 2017
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REGULATORY As Complaints of Shortages Grow for Japanese Encephalitis Vaccine, MHLW Plans Centralized Collection/Feedback of Supply-Demand Data for Distributers
September 27, 2017
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TRENDS Japan’s “NDB” Insurance Claim Database Corroborates Slack SGLT-2 Prescriptions for Older People in FY2015
September 26, 2017
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BUSINESS Opdivo Gains Nod for Gastric Cancer; Spinraza Now Available for All SMA Patients
September 25, 2017
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BUSINESS Medipal to Become JCR’s Top Shareholder, Poised to Form JV in US
September 22, 2017
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BUSINESS CSL Ramping Up Investment for New Product Development, 11% R&D-to-Sales Ratio “Appropriate”: CEO
September 22, 2017
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REGULATORY Kaketsuken in Talks with “Several Entities” over Possible Biz Transfer: New Chief
September 21, 2017
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BUSINESS NCC, Top 3 Japan Makers Form Immunotherapy Consortium with Eye on Alternative to PD-1 Inhibitors
September 20, 2017
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BUSINESS Armed with Japanese Data, Nichi-Iko Confident of Besting Nippon Kayaku in Remicade Biosimilar Race
September 19, 2017
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BUSINESS Chugai’s On-the-Spot ADR Info Provisioning Tools Well Received by Physicians, Spreading to Other Makers
September 15, 2017
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REGULATORY With 253 Billion Yen Estimate Out, Chuikyo Members Prod MHLW to Vet Impact of Price Maintenance Premium
September 14, 2017
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REGULATORY (Update) Similar “Treatment” Comparison Method Could Be Up for Discussion as New Pricing Scheme: Chuikyo
September 13, 2017
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For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…