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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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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…
