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REGULATORY
- MOF Budget Examiner Questions Price Maintenance Premium, Says Its Impact Amounts to Over 253 Billion Yen in FY2017
September 12, 2017
- MHLW to Draft GL on Use of Real World Data in Application Filings to Promote Development of Drugs for Rare Diseases
September 12, 2017
- Kyorin’s Dimethyl Sulfoxide Gets Orphan Status in Japan
September 11, 2017
- MHLW Panel Backs Japan’s 1st PD-L1 Inhibitor, 8-Week Hep C Med and More
September 11, 2017
- Opdivo Clears MHLW Panel for 3rd Line Use in Gastric Cancer, Keytruda to Lose Sakigake Status
September 8, 2017
- Social Security Council Begins Discussion on Basic Policy for FY2018 Reimbursement Reform
September 8, 2017
- MEXT’s FY2018 Budget Request to Include Funding to Build Biobank Network
September 8, 2017
- MHLW Sets Out Plan to Ease Export Ban for Plasma Fraction Products
September 7, 2017
- MHLW Working Group to Draw Up Elderly Polypharmacy Guidelines in 2 Stages
September 4, 2017
- Spinraza Add’l Indication Reported to MHLW Panel, Setting Stage for Its Use in All SMA Patients
September 4, 2017
- Programs Funded by MA Holder or Its Subsidiaries Subject to Regulations under Clinical Research Law
September 1, 2017
- MHLW to Form Study Group to Address Leftover Vial Drug Issue, Weighs Multi-Dose Vials
August 30, 2017
- MHLW Panels Eye Cognitive Behavioral Therapy Approach for Post-HPV Vaccine Symptoms
August 29, 2017
- New Minister Has Hopes for Pharma Industry in Both Medical and Economic Fronts, Wants to Balance Innovation and Cost
August 29, 2017
- MHLW Predicts 4% Reduction in Flu Vaccine Production in FY2017, Will Take Steps to Prevent Shortage
August 29, 2017
- MHLW OKs Add’l Indications for Revolade, Actemra and More
August 28, 2017
- Opdivo’s Gastric Cancer Use, Avelumab and More Up for MHLW Panel Review/Report on Sept. 8
August 28, 2017
- MHLW Health Policy Bureau to Initiate a New Project to Increase Understanding of Biosimilars; FY2018 Budget Request
August 28, 2017
- MHLW Pharmaceutical Safety Bureau Seeks 10.3 Billion Yen in FY2018 Budget; Includes Funding for 6 Add’l Personnel at PMDA
August 28, 2017
- MHLW Working Group to Kick Off Discussions on Guidelines to Address Elderly Polypharmacy
August 25, 2017
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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…
