LEXICON
No.153 August 17, 2016

Sakigake Designation Scheme
先駆け審査指定制度

Japan introduced the “ sakigake ” designation scheme (先駆け審査指定制度; sakigake shinsa shitei seido ) on a pilot basis in 2015, aiming to accelerate the time to market for innovative drug candidates by giving them a series of privileges in both...

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LEXICON

By Reiji Anasako

Despite getting off to a sluggish start five years ago, SGLT2 inhibitors are steadily picking up steam thanks to buoyant sales of their combination medicines with DPP-4 inhibitors. Even monodrugs alone grew 29% in FY2018, with the market including the…

By Tatsuya Otsuka

Generic drug makers are making greater efforts to disclose more information on their products after years of repeated requests from doctors and medical institutions, which want to better ascertain their quality and stability of their supplies.Ohara Pharmaceutical has been disclosing…

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With Novartis’ CAR-T therapy Kymriah (tisagenlecleucel) hogging the headlines for its biggest-ever price tag in Japan, many continue to perceive high-price medicines as the main culprit of strained health finances, contending that they are driving up drug spending. But, is…

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Riding on the back of an improved regulatory environment in China, major Japanese drug makers are moving to expand their businesses in the world’s second largest pharma market. Companies are pumping up their new drug pipelines, while forging solid sales…

By Yoshinori Sagehashi

As Japan heralds the new imperial era of Reiwa, Eisai CEO Haruo Naito sat with Jiho to look back on…

By Takashi Ebisawa and Tatsuya Otsuka

Japan’s generic market is hitting a plateau soon. Incentive measures rolled out by the government since 2002 have driven its…

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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…

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