BUSINESS
SanBio’s Lead Cell Therapy Rides High with FDA’s RMAT Designation for Traumatic Brain Injury
September 20, 2019
After grabbing Japan’s sakigake fast-track status back in April, SanBio said on September 19 that it has won the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for its lead stem cell therapy SB623 for the…

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September 20, 2019
Japanese health regulators are following in the footsteps of its counterparts in the US and Europe to review medicines containing ranitidine for their potential contamination with a cancer-causing impurity called N-nitrosodimethylamine (NDMA).On September 17, the Ministry of Health, Labor and…
September 20, 2019
JCR Pharmaceuticals said on September 19 that it has withdrawn its application in Japan for the label expansion of its human mesenchymal stem cell therapy Temcell for the treatment of epidermolysis bullosa (EB) in order to demonstrate its efficacy “with…
September 20, 2019
The Ministry of Health, Labor and Welfare (MHLW) removed its sakigake fast-track designation for Biogen’s aducanumab on September 19 after its major PIII flops earlier this year, making it the second such withdrawal, after Keytruda (pembrolizumab) for its gastric cancer…
By Yoshinori Sagehashi

As Japan gears up for its next drug pricing reform in April 2020, Shoji Kono, director of the National Federation…

By Reiji Anasako

Pharmaceutical sales per rep in Japan, a yardstick for “productivity” at drug makers, reached a record 172 million yen in FY2018, up 20 million yen from five years ago, as companies continue ramping up their job-shedding drive in a bid…

By Takashi Ohama

An adult man who completed the administration of an investigational drug in a Japan PI study conducted by Eisai has died. Whether there was a causal relationship between the drug and the subject’s death remains unclear at the present time,…

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 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

Jascha Heifetz, widely regarded as one of the greatest violinists of all time, was once stopped, on 57th Street in Manhattan, by a pedestrian asking, “Could you tell me how to get to Carnegie Hall?” Heifetz pondered the question for…

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