BUSINESS

EMA Accepts Roxadustat for Review

May 22, 2020
Astellas Pharma and its US partner FibroGen said on May 21 an application for their hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor roxadustat has been accepted for review in Europe for the treatment of anemia in adult patients with chronic kidney…

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BUSINESS

By Takashi Ohama

On July 17, Japan’s Cabinet adopted the 2020 Basic Policy on Economic and Fiscal Management and Reform (honebuto). Its initial text suggested the government’s position to carry out its first off-year drug price revision next April as well as its…

By Takashi Ebisawa

Since last year, Japan has seen a number of stock-outs and shortages of generic drugs attributable to API supply disruptions…

By Takamitsu Sasai

Nearly a year after the introduction of the Ministry of Health, Labor and Welfare’s (MHLW) drug promotion guidelines in April…

By Takashi Ebisawa

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…

By Yoshinori Sagehashi

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…

By Philip Carrigan

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…