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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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