Japan introduced a new health coverage scheme for long-listed products (LLPs) on October 1. A survey of generic drug makers…
REGULATORY
Advisory Panel Shelves Decision on Avigan, Says No Clear Efficacy Shown for COVID-19
A key health ministry advisory committee on December 21 put a hold on its decision on whether to back approval for Fujifilm’s antiviral Avigan (favipiravir) for the treatment of COVID-19, saying that it is “difficult to conclude the drug’s clear…
To read the full story
Related Article
- Avigan Used Improperly for 429 Patients in Observational Study: MHLW
February 21, 2023
- Fujifilm Ditches Avigan COVID-19 Program, Pulls Submission in Japan
October 17, 2022
- Fujifilm Drops Avigan’s Japan PIII Trial for COVID-19
March 14, 2022
- Japan Govt to End Observational Avigan Study for COVID-19
January 5, 2022
- Plunge in COVID-19 Cases Stalling Japan Avigan Study by Few Months
November 5, 2021
- Fujifilm Launches New Japanese Avigan PIII Study for COVID-19
April 22, 2021
- 10,000 COVID-19 Patients Received Avigan in Observational Studies: Govt
February 25, 2021
- Govt Giving Advice to Fujifilm after Shelving Decision on Avigan
February 1, 2021
- Avigan’s COVID-19 Use Up for PAFSC Review on December 21
December 17, 2020
- Avigan to Come Up for PAFSC Review This Month
December 16, 2020
- (Update) Avigan Filed for COVID-19 in Japan: Fujifilm
October 16, 2020
- Avigan Filed for COVID-19 in Japan: Fujifilm
October 16, 2020
- Avigan Hits Primary Goal for Novel Coronavirus, Filing Eyed in October: Fujifilm
September 24, 2020
- Fujifilm’s Avigan COVID-19 Data Won’t Be Fully Ready until 1 Month from Now
August 21, 2020
- Fujifilm-Sponsored Avigan Trial to Complete Enrollment on Aug. 16
August 12, 2020
- Avigan Fails to Hit Statistical Significance in COVID-19 Trial: Fujita Health Univ.
July 13, 2020
- Fujifilm Inks Global Avigan Deal with Dr. Reddy’s, Global Response Aid
July 2, 2020
- Fujifilm’s Avigan COVID-19 Trial Might Continue into July
June 9, 2020
- Most Mild COVID-19 Patients Recovered on Avigan, but Careful Interpretations Needed for Single-Arm Study: Interim Report
May 27, 2020
- Japan Drops May-End Goal for Avigan’s COVID-19 Approval
May 27, 2020
- Fujifilm Launches Avigan Trial with Completion Eyed in June; Sanofi Too to Test Kevzara in Japan
April 1, 2020
REGULATORY
- MHLW Asks for Ramp Up of HPV Vaccines after 5-Fold Rise in Demand
October 11, 2024
- MHLW Orders Label Revision for Systemic NSAIDs
October 11, 2024
- Xocova to Face CEA Price Cuts on Poor Cost Performance vs. SOC
October 10, 2024
- Kisunla to Follow Same Rules as Leqembi in Pricing and Post-Launch Review
October 10, 2024
- Supply of Anapeine Generic to Start by Year-End: Minister
October 9, 2024
It’s easy to spot motivated and engaged employees. They are more productive, they go the extra mile, and they display a sense of ownership in their work.But how do you replicate this culture throughout your organization? How do you encourage…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…