REGULATORY
First “Post-Nesp” Renal Anemia Med Could Land Japan Approval in September
August 16, 2019
Astellas Pharma’s roxadustat could gain Japanese approval as early as September as the first product in the class of drugs called hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors, which are hailed as “post erythropoiesis-stimulating agent (ESA)”…

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August 16, 2019
The biosimilar debut for Eli Lilly’s big-seller osteoporosis drug Forteo (teriparatide) is drawing near as the Japanese health ministry is scheduled to report late this month its plan to approve its first follow-on version filed by Mochida Pharmaceutical. If all…
August 16, 2019
AbbVie’s chronic lymphocytic leukemia (CLL) treatment venetoclax will come up for review by a key health ministry advisory panel on August 23. If given the go-ahead, the drug, known as Venclexta and Venclyxto overseas, will gain the official stamp of…
August 16, 2019
The Ministry of Health, Labor and Welfare (MHLW) on August 15 gave the thumbs-up to a slew of generic drugs ahead of the next generic reimbursement listing in December, including what might be an authorized generic (AG) version of MSD/Bayer’s…
By Reiji Anasako

Forging ahead with its new three-year business plan, Chugai Pharmaceutical enjoyed rosy earnings in the first half of 2019, bolstered by the outperformance of the Hemlibra (emicizumab) hemophilia drug and its I/O star Tecentriq (atezolizumab). But with a biosimilar onslaught…

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…

By Reiji Anasako

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…

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 2011 the Japanese pharmaceutical industry was rocked when a whistleblower exposed the falsification of trial data for the drug Diovan, the blockbuster blood pressure drug manufactured by pharma giant Novartis. The ensuing investigation led to the arrest of one…

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