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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BUSINESS Chugai Shifting Resources to Beef Up Drug Discovery Prowess: New Chief
April 13, 2020
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BUSINESS Sanofi Launches Kevzara Trial for Severe COVID-19 in Japan
April 10, 2020
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BUSINESS Fujifilm to Start PII Avigan Trial for COVID-19 in US
April 10, 2020
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BUSINESS Nichi-Iko Recalling 12 APIs/15 Products over Quality, Compliance Issues
April 9, 2020
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REGULATORY Should Japan Go Ahead with Off-Year Re-Pricing amid COVID-19 Outbreak? Chuikyo Members Want It Discussed
April 9, 2020
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BUSINESS Chugai to Launch Actemra PIII Trial for Coronavirus
April 9, 2020
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REGULATORY Japan Books 13.9 Billion Yen to Boost Avigan Stockpile, Abe Vows to Expand Access to Fujifilm Drug
April 8, 2020
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BUSINESS Rush to BCG Vaccine for COVID-19 Leads to Curbs on Shipments
April 7, 2020
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BUSINESS Big 3 Generic Maker Curbing Valsartan Shipments amid India Lockdown
April 6, 2020
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REGULATORY Japan’s Stimulus Package Likely to Support API Manufacturing Repatriation, Vaccine/Drug Development
April 3, 2020
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REGULATORY Gilead-Sponsored Remdesivir Trial Expected to Start This Month: Minister
April 3, 2020
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BUSINESS Amgen Kicks Off Stand-Alone Biz in Japan, Eyes Simultaneous Launch of Full Pipeline
April 2, 2020
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BUSINESS Fujifilm Launches Avigan Trial with Completion Eyed in June; Sanofi Too to Test Kevzara in Japan
April 1, 2020
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BUSINESS Fujifilm Wants to Launch Avigan Trial in Japan by End of This Week, Abe Talks to WHO Chief
March 31, 2020
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REGULATORY Global Health Confab Issues Proposals for Regulatory Harmonization in Asia
March 31, 2020
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BUSINESS Daiichi Sankyo Files Yescarta, Second CAR-T Therapy in Japan
March 30, 2020
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REGULATORY New Stable Supply Panel Wants to Define “Key Drugs” by This Summer
March 30, 2020
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REGULATORY PM Abe Says Japan to Start Registration Trial for Avigan for COVID-19, Plans Production Boost
March 30, 2020
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REGULATORY Social Security Council at Odds over Future CEA Use, but Agrees to Watch Chuikyo Debate
March 27, 2020
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REGULATORY Japan OKs Enhertu, 3 Sakigake Drugs, Beovu, Latuda, and More
March 26, 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…
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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…