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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- MSD’s 9-Valent HPV Vaccine Nearing Finish Line in Japan 5 Years after Filing, but Vaccination Policy Remains Iffy
April 13, 2020
- 15 Insulins, Erleada, Faslodex under PMDA Safety Review
April 13, 2020
- MHLW Urges Drug Makers, Wholesalers to Ensure Stable Drug Supplies amid Emergency
April 10, 2020
- MHLW Plans to Revise National Vaccine Certification Rules in June
April 10, 2020
- League of Lawmakers Urges MHLW to Help COVID-19 Drug/Vaccine Development
April 10, 2020
- Chuikyo Allows Round Robin Meetings for Coronavirus-Related Matters
April 9, 2020
- Should Japan Go Ahead with Off-Year Re-Pricing amid COVID-19 Outbreak? Chuikyo Members Want It Discussed
April 9, 2020
- PMDA to Accept Trial Notifications by Email amid Coronavirus Outbreak
April 9, 2020
- MHLW Staffer Infected with Novel Coronavirus
April 9, 2020
- Talks with Regulators Ongoing for Ferinject, Zeria Says after Skipping Listing 4 Times
April 9, 2020
- AMED Invites Research Projects for COVID-19 Vaccine Development from Mid-April
April 9, 2020
- World’s 1st Topical JAK Inhibitor Corectim, AbbVie’s Rinvoq, Bayer’s Nubeqa OK’ed for Listing on April 22
April 8, 2020
- Novartis Japan Chided over Flawed Zolgensma Data, Delayed Responses
April 8, 2020
- Japan Books 13.9 Billion Yen to Boost Avigan Stockpile, Abe Vows to Expand Access to Fujifilm Drug
April 8, 2020
- Carcinogen in On-Market Nizatidine Products Acceptable Levels: MHLW
April 6, 2020
- Companies Should Reward Consistent Compliance with Detailing Guidelines in Performance Evaluations: MHLW Study
April 6, 2020
- Japan Mulling Free Avigan Supplies to 30-or-So Countries for COVID-19
April 6, 2020
- MHLW Allows Online IRB Meetings for Coronavirus Trials
April 3, 2020
- Japan’s Stimulus Package Likely to Support API Manufacturing Repatriation, Vaccine/Drug Development
April 3, 2020
- Companies “May” Provide Information to Individual Patients at Their Request: MHLW
April 3, 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…