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
- Japan Poised to Quickly Approve Futhan, Actemra, Ivermectin for COVID-19 If Effective: Abe
May 15, 2020
- 400,000 Antigen Test Kits for COVID-19 to Be Supplied by End of May: Health Minister
May 15, 2020
- Suspected COVID-19 Cases to First Receive Antigen Test, Followed by PCR Test if Result is Negative: Suga
May 15, 2020
- COVID-19 Vaccines Too Could Be Filed without Clinical Trial Data: Official
May 15, 2020
- MHLW Urging Novartis to Ensure Speedy Zolgensma Supplies: Sr. Vice Minister
May 15, 2020
- Coefficients for Cost-Based Pricing Formula Updated: Chuikyo
May 15, 2020
- Chuikyo Members Frown on Zolgensma’s Sakigake Premium; Topic Up for 2022 Pricing Debate
May 14, 2020
- MHLW to Accept Applications for COVID-19 Treatments Without Clinical Trial Data; Avigan, Alvesco, Futhan Might Be Eligible
May 14, 2020
- GCP Inspections Might Be Postponed amid COVID-19 Outbreak: MHLW
May 14, 2020
- Daiichi Sankyo’s Enhertu, Novartis’ Beovu, Novo’s Ozempic OK’ed for Listing on May 20
May 13, 2020
- Japan Regulators Upped Zolgensma Price after Novartis Complaints: Chuikyo Paper
May 13, 2020
- Japan Starts Distributing Veklury with Supply Volume Undisclosed
May 13, 2020
- Govt Officials Urge Japan Pharma Companies to Be More Proactive in Coronavirus Vaccine Development
May 12, 2020
- Japan COVID-19 Vaccine Trial Could Begin as Early as July: Abe
May 12, 2020
- Zolgensma to Get Japan’s Highest List Price 167 Million Yen, but Peak Sales Put at Just 4 Billion Yen
May 12, 2020
- Kato Repeats May-End Goal for Avigan OK, Negative for Use in Mildly Ill Patients
May 11, 2020
- Chuikyo OKs Special Mixed Care Scheme for Veklury
May 11, 2020
- Japan Approves Remdesivir as First Drug for COVID-19
May 8, 2020
- Gilead Japan Expected to Offer Remdesivir for Free for Now
May 7, 2020
- Japan to Test Ivermectin for COVID-19: Prime Minister
May 7, 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…