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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REGULATORY Check Latest Info and Make Careful Decision on Veklury Use: PMDA Review Report
May 19, 2020
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BUSINESS Many Drug Makers Continue Work-from-Home, Voluntary Visit Bans after Govt Partially Lifts COVID-19 Emergency
May 18, 2020
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BUSINESS Takeda Revving Up Efforts to Retool Japan Sales System as It Prepares for “New Normal” Post COVID-19
May 18, 2020
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REGULATORY Japan’s First Humira Biosimilar Could Hit Market as Early as November
May 15, 2020
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REGULATORY Japan Poised to Quickly Approve Futhan, Actemra, Ivermectin for COVID-19 If Effective: Abe
May 15, 2020
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REGULATORY Chuikyo Members Frown on Zolgensma’s Sakigake Premium; Topic Up for 2022 Pricing Debate
May 14, 2020
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BUSINESS Eisai Resurrects Eritoran as Potential COVID-19 Treatment, Eyes Trial Launch Next Month
May 14, 2020
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BUSINESS Takeda Exec Says Plasma Alliance Could Start Clinical Trial for Unbranded Therapy in July
May 14, 2020
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REGULATORY Daiichi Sankyo’s Enhertu, Novartis’ Beovu, Novo’s Ozempic OK’ed for Listing on May 20
May 13, 2020
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REGULATORY Japan Regulators Upped Zolgensma Price after Novartis Complaints: Chuikyo Paper
May 13, 2020
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REGULATORY Zolgensma to Get Japan’s Highest List Price 167 Million Yen, but Peak Sales Put at Just 4 Billion Yen
May 12, 2020
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BUSINESS Amgen Boosting Repatha Supply System to Gear Up for Praluent Switches
May 11, 2020
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BUSINESS Praluent Barred in Japan after Top Court Nixes Sanofi’s Patent Claim
May 8, 2020
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REGULATORY Japan Approves Remdesivir as First Drug for COVID-19
May 8, 2020
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REGULATORY Japan to Test Ivermectin for COVID-19: Prime Minister
May 7, 2020
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REGULATORY Remdesivir Likely to Get Japan Nod on May 7
May 6, 2020
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BUSINESS Gilead Files Remdesivir for COVID-19 in Japan
May 4, 2020
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REGULATORY Japan Likely to Take FDA’s Anticipated EUA as Cue for “Special” Remdesivir OK
May 1, 2020
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BUSINESS Sanofi Japan to Ensure Drug Supplies, Employees’ Safety at the Same Time in COVID-19 Crisis: Chief
April 30, 2020
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REGULATORY Japan Might Approve Gilead’s Remdesivir for COVID-19 in May
April 28, 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…