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REGULATORY
- Pfizer’s Lorlatinib Gets 1st Conditional OK; MHLW Approves Astellas AML Drug and More
September 25, 2018
- MHLW Panel Members Share Views on One Key Topic toward PMD Law Amendment; Next Meeting Scheduled Soon: Official
September 25, 2018
- Recordati Succeeds Carbaglu Orphan Drug Designation from Pola Pharma
September 20, 2018
- MHLW Orders Package Insert Revision for Xofigo, Warning of Increased Risk of Death, Bone Fracture with 3-Drug Combination
September 20, 2018
- Pfizer to Use MID-NET Database for Ibrance PMS
September 19, 2018
- Second Applicant from Pharma Companies to Use MID-NET: PMDA
September 19, 2018
- Alexion’s PNH Therapy Ravulizumab, Two other APIs Bag Orphan Drug Designations
September 19, 2018
- MHLW Drug Pricing Official Calls on Industry to Present Specific Proposal on PMP
September 19, 2018
- MHLW to Launch Mock Review Project to Up Standards of “Certified IRBs” under Clinical Research Law: Official
September 14, 2018
- Tailwind for Prevenar 13? Vaccine Panel Members Up for Its Use in High-Risk Elderly
September 11, 2018
- JPMA Official Hails MHLW Discussions on Use of “Specified Clinical Research” Data in Application Dossiers
September 10, 2018
- 4th Sakigake Invitation to Start on October 1: MHLW
September 10, 2018
- MHLW to Promote Optimization of Plasma Fraction Product Transactions: New Blood Product Chief
September 7, 2018
- MHLW to Discuss Measures to Strengthen Governance among Blood Collection Operators through Amendment of Blood Law
September 7, 2018
- MHLW to Embrace Communications with Industry on Drug Pricing Overhaul: Medical Economics Chief
September 6, 2018
- Data Protection Period Extended for Feburic, Cubicin: MHLW
September 6, 2018
- Otezla, Ceftriaxone Labels Revised: MHLW Safety Bulletin
September 5, 2018
- New “Center of Excellence” to Be Set Up in US to Train Regulators from APEC Region, Promote Multiregional Clinical Trials
September 5, 2018
- India Plans to Exempt Domestic Study for Japan-Approved Drugs
September 4, 2018
- MHLW, METI Seek 3-Year Extension for Temporary R&D Tax Credit Measures
September 3, 2018
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