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REGULATORY
- PMDA Review Report: Pfizer Vaccine’s Efficacy for Variants Not Gauged in Clinical Trials, Continued Info Collection Needed
February 16, 2021
- Japan to Start COVID-19 Vaccination on Feb. 17: PM Suga
February 15, 2021
- PMDA to Expand MID-NET Use in Revised Guidelines from April
February 15, 2021
- JCR’s Sakigake Designated Hunter Syndrome Med Up for PAFSC Review on Feb. 25
February 15, 2021
- Pfizer Vaccine Deal Based on “Number of Doses”, Not Vials: Minister
February 15, 2021
- Japan Approves Pfizer’s COVID-19 Vaccine, Rollout Set for Mid Week
February 15, 2021
- Chuikyo OKs Flow of CEA-Based Re-Pricing, New Price Effective 3 Months after Announcements
February 12, 2021
- MHLW Orders Pref. Govts to Strengthen Snap Inspections against Drug Makers after Kobayashi Kako Fiasco
February 12, 2021
- Japan Now Sees Fewer Doses per Pfizer Vaccine Vial as Special Syringes Run Short
February 12, 2021
- Incyte’s Pemigatinib Up for PAFSC Review on Feb. 22, March Approval Likely?
February 10, 2021
- LDP Project Team Draws Up Proposal on COVID-19 Vaccination System
February 10, 2021
- New Versions of Trelegy, Lasvic Approved for Listing on Feb. 18
February 10, 2021
- EU OKs Export of 1st Batch of Pfizer’s Coronavirus Vaccines: Minister
February 10, 2021
- Kobayashi Kako Slapped with Record 116-Day Business Suspension
February 9, 2021
- Pfizer’s COVID-19 Shot Up for PAFSC Review Feb. 12, Kono Expects Govt to Secure Enough Doses for 1st-in-Line HCPs
February 9, 2021
- Regulators to Issue Biz Suspension Order to Kobayashi Kako on Feb. 9
February 8, 2021
- MHLW, Saudi Govt Sign Memo on Regulatory Harmonization; Japan-Listed Drugs to Get Priority Review
February 4, 2021
- Drug Pricing Rules to Be Applied to Yescarta: Chuikyo
February 4, 2021
- Celgene’s Liso-Cel Up for PAFSC Review on Feb. 17, 3rd CAR-T Therapy in Japan
February 4, 2021
- New EU Export Regulations Affecting Japan’s Vaccine Supply Schedule: Kono
February 3, 2021
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