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REGULATORY
- Japan Approves Label Expansions for Humira, Other Drugs
February 22, 2019
- MHLW Panel OKs AnGes’ Gene Therapy Collategene for Conditional Approval
February 21, 2019
- Kymriah in Line for Japan Approval Next Month as It Gets Key Panel Nod
February 21, 2019
- Japan to Roll Out Cost-Effectiveness Assessment Scheme in April
February 21, 2019
- MHLW Makes No Change to Drug Prices, but Corrects Pricing Coefficient after Wage Scandal, Sloppy Errors Also Found
February 21, 2019
- MHLW Acknowledges Need to Ponder Rules for “Regenerative Medicines”: Official
February 21, 2019
- Doctor Rep Calls for Discussion to Ensure Proper Use of Osteoporosis Treatment Evenity: Chuikyo
February 21, 2019
- Japan OKs Listing of Evenity, Tarlige, Epclusa, and More on Feb. 26
February 20, 2019
- Stemirac Fetches 15 Million Yen Price Tag, Peak Sales Put at 3.7 Billion Yen
February 20, 2019
- HSC Panel Discusses Data Standardization to Promote Use of Real World Data
February 19, 2019
- Japan Approves Symbicort Generics, Asthma Drug Stalwart Could Face Competition in June
February 15, 2019
- Chuikyo Issues Recommendation on October Tax Hike Medical Fee Revision; No Timeline for New Drug Price Announcement
February 14, 2019
- Label Revisions Ordered for PD-1 Inhibitors, Ibrance, Maviret, and More
February 13, 2019
- Kymriah Pre-Treatment Regimens Up for Review on Feb. 22
February 12, 2019
- MHLW Panel to Review Gilead’s Biktarvy, GSK’s Trelegy and More on Feb. 22
February 12, 2019
- MHLW Council Recognizes High Unmet Medical Needs for Busulfan, Octreotide
February 12, 2019
- Pfizer’s Sakigake-Designated Vyndaqel, Shionogi’s Vyvanse Up for MHLW Panel Review on Feb. 21
February 8, 2019
- 4 Public Comments Received for Ad-Hoc Re-Pricing in October
February 7, 2019
- MHLW Panel to Discuss Orphan Status for Takeda’s Stem Cell Therapy on Feb. 20
February 7, 2019
- Importance of Non-ICER Factors in Cost-Effectiveness Assessment Starting to Resonate with Chuikyo Reps
February 7, 2019
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
