The Ministry of Health, Labor and Welfare (MHLW) appears to be ready to begin post-launch drug price adjustments based on cost-effectiveness assessments (CEAs) for the first time since the system was introduced in April 2019. As price tweaks will be…
BUSINESS
Pfizer/BioNTech’s COVID-19 Vaccine Filed in Japan, Exceptional OK Eyed
Pfizer and German biotech partner BioNTech filed their mRNA-based COVID-19 vaccine in Japan on December 18. With this, the Japanese health ministry will now review it on the exceptional approval pathway, as requested by the companies. According to Pfizer’s Japan…
To read the full story
Related Article
- 2nd-Dose Shot Starts for COVID-19 Vaccination in Japan
March 12, 2021
- PAFSC Minutes for Pfizer Vaccine Disclosed
March 1, 2021
- Japan Launches COVID-19 Vaccination Program
February 18, 2021
- COVID-19 Vaccine Being Rolled Out for 40,000 Healthcare Workers in Japan
February 17, 2021
- Pregnant Women Not Urged to “Make Efforts” to Get COVID-19 Vaccines
February 16, 2021
- PMDA Review Report: Pfizer Vaccine’s Efficacy for Variants Not Gauged in Clinical Trials, Continued Info Collection Needed
February 16, 2021
- Japan Approves Pfizer’s COVID-19 Vaccine, Rollout Set for Mid Week
February 15, 2021
- Japan Moves Up Vaccine Rollout Target to Mid-February, PAFSC Review on Feb. 12?
February 3, 2021
- Japan to Set Up Real-Time Tracking System for COVID-19 Vaccination: Kono
January 26, 2021
- Japan Preps for COVID-19 Vaccine Rollout for HCPs by Late February: Minister
January 25, 2021
- Japan Govt Starts COVID-19 Vaccine Website, Plans Air/Land Shipments by Logistics Firms for Pfizer Shots
January 25, 2021
- Japan, Pfizer Finalize COVID-19 Vaccine Deal, Agree on Supply of 144 Million Doses
January 21, 2021
- Japan Weighs Pfizer COVID-19 Vaccine Rollout for Age 16 and Up
January 20, 2021
- Govt Eager to Roll Out 1st COVID-19 Vaccine by Late February; PM Says Pfizer’s Japan Data Ready by Month-End
January 5, 2021
- Decision on Pfizer Vaccine Unlikely to Come before Japan Data Submission Slated by February
December 21, 2020
- Pfizer, BioNTech Begin Japan PI/II Study for COVID-19 Vaccine
October 21, 2020
- Pfizer to Supply COVID-19 Vaccine Doses for 60 Million People in Japan
August 3, 2020
BUSINESS
- MSD Japan Suffers 7% Sales Dip on Repeated Keytruda Re-Pricing, Urges Policy Rethink
April 21, 2021
- FDA Accepts Astellas/Seagen’s Submissions for Padcev’s Full Approval, Label Expansion
April 21, 2021
- Oncolys to Codevelop COVID-19 Med with Shin Nippon Biomedical
April 21, 2021
- Life Science Institute to Begin Exploratory Study of Muse Cell Therapy for COVID-19-Associated ARDS
April 21, 2021
- New Grad Hiring Down 3.3% at 55 Drug Makers, Sales Rep Opportunities Fall amid DX: Survey
April 20, 2021
Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…
Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…
The Ministry of Health, Labor and Welfare (MHLW) on November 27 added to the NHI price list Japan’s first biosimilars of Avastin (bevacizumab), Nesp (darbepoetin alfa), and Forteo (teriparatide). The NHI prices of first biosimilars are set at 70% of…
Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…
After decades in recruitment, I say from experience that there’s a particular way to attract candidates to a given role. Do it right, and you’ll have talent chasing you. Get it wrong, and you’ll be left listening to the crickets…