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…
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- Japan Eyes May Approval for Avigan with Investigator-Led Study Data
May 7, 2020
- Remdesivir Likely to Get Japan Nod on May 7
May 6, 2020
- Japan Eyes Manufacturing Repatriation for 3 APIs: Extra Budget
May 1, 2020
- Japan Likely to Take FDA’s Anticipated EUA as Cue for “Special” Remdesivir OK
May 1, 2020
- Japan Can’t Give “Special Approval” for Avigan under Current Law: Abe
April 30, 2020
- Japan to Quickly Utilize “Special Approval” Scheme for Remdesivir after It’s OK’ed Overseas: Minister
April 30, 2020
- Antigen Test for New Coronavirus Filed in Japan: Minister
April 28, 2020
- Japan Might Approve Gilead’s Remdesivir for COVID-19 in May
April 28, 2020
- Japan Starts Assessing Performance of Antibody Test Kits: Minister
April 27, 2020
- Drug Makers Should Join in “Concerted National Effort” to Propel Regulatory Harmonization in Asia: Ex-PMDA Chair
April 27, 2020
- Japan Moving to Thwart Foreign Takeover of Drug, Medical Devices Makers
April 24, 2020
- In a First, Chuikyo to Be Streamed Live amid COVID-19 Outbreak
April 23, 2020
- Japan to Make Drug Review Time as Short as Possible for COVID-19: Minister
April 22, 2020
- Novartis’ Entresto, Mayzent Up for MHLW Panel Review in Round Robin Method
April 20, 2020
- Japan Declares Nationwide State of Emergency
April 17, 2020
- MSD’s 9-Valent HPV Vaccine Up for Review in 1st Online PAFSC Meeting
April 16, 2020
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- Osaka Pref., Osaka Univ. Form Alliance for COVID-19 Vaccine; AnGes Clinical Study Planned as Early as July
April 16, 2020
- MHLW Asks Drug Makers, Wholesalers to Reduce People Coming to Work by “at Least 70%”
April 15, 2020
- Health Minister Vows to Shorten Review Time for Avigan
April 14, 2020
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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…