The delayed approval and price setting of Novartis Pharma’s Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA) listed in May, has raised questions about how the sakigake designation system should be operated. Despite being designated for the…
HOME > REGULATORY
REGULATORY
- Gilead-Sponsored Remdesivir Trial Expected to Start This Month: Minister
April 3, 2020
- PMDA Introduces 3 New Consultation Services
April 2, 2020
- PMDA Issues Q&A for Trial Implementations in Coronavirus Crisis
April 2, 2020
- Keidanren Calls for Review of Health Coverage for OTC-Like Drugs
April 2, 2020
- Japan’s Healthcare Would Collapse before “Overshoot,” Govt Panel Warns
April 2, 2020
- Japan Ruling Parties Call for Fund to Support Healthcare Delivery System
April 2, 2020
- MHLW Orders Label Revisions for Keytruda, Xofluza and More; 1st MID-NET-Based Safety Step Taken
April 1, 2020
- LDP to Suspend Committee Meetings from April 2-12
April 1, 2020
- Govt, LDP Moving to Review Supply Chains in Response to COVID-19 Pandemic
April 1, 2020
- Japan’s 1st In Vitro Diagnostic Test Kit for Novel Coronavirus Approved: Sysmex
March 31, 2020
- Global Health Confab Issues Proposals for Regulatory Harmonization in Asia
March 31, 2020
- Japan Hammers Out New 5-Year Health, Medical Strategy
March 30, 2020
- New Stable Supply Panel Wants to Define “Key Drugs” by This Summer
March 30, 2020
- PMDA Asking Companies to Seek Advice for Trial Rescheduling
March 30, 2020
- PM Abe Says Japan to Start Registration Trial for Avigan for COVID-19, Plans Production Boost
March 30, 2020
- Ex-Tokyo Tech President Yoshinao Mishima Named AMED Chief from April
March 30, 2020
- Social Security Council at Odds over Future CEA Use, but Agrees to Watch Chuikyo Debate
March 27, 2020
- ICH Vancouver Meeting Cancelled due to COVID-19 Pandemic
March 27, 2020
- MHLW to Make Pediatric Medical Database Available to Researchers on Trial Basis
March 26, 2020
- OxyContin’s Chronic Pain Nod Delayed as Distribution System Not Ready
March 26, 2020
ページ
When Jiho surveyed drug makers on the non-sales criteria they use to evaluate reps’ performance, it received a variety of…
Nearly a year after the introduction of the Ministry of Health, Labor and Welfare’s (MHLW) drug promotion guidelines in April…
Advancements in modified oligonucleotide technologies has been the key driver behind a spate of approvals in the oligonucleotide therapeutics space…
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…
A total of 51 new drugs joined the NHI price list in 2019, which are expected to generate combined peak sales of 373 billion yen, according to Jiho’s tally of data submitted to a key reimbursement policy panel. The relatively…
Some seven years in the making, Japan’s Ministry of Health, Labor and Welfare (MHLW) finally rolled out a cost-effectiveness assessment…
Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…
In a change striking to the very core of the traditional Japanese salaryman, “We are seeing the coronavirus ushering in a new way of working… and I think it’s about time,” says Ivan Tselichtchev, Professor of Economics at the Niigata…