ACADEMIA

Gynecologist Cautious about Inclusion of Pregnant Women in Clinical Trials, but Says ICH Move Will Spark Safety Discussions

By Tatsuya Otsuka July 14, 2022
Back in May, the International Council for Harmonization (ICH) agreed to create a new guideline on the “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials.” In a recent interview with Jiho, a gynecologist took a cautious position about the…

To read the full story

ACADEMIA

By Shinya Sato

A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…

By Ken Yoshino

Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…

For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…

By Philip Carrigan

In a recent conversation with James Feliciano, former president of AbbVie Japan, we delved into the intricacies of leadership in the Japanese pharmaceutical industry. Feliciano, a seasoned industry veteran, shared valuable insights into his experiences, challenges, and successes.Navigating the Abbott…

By Takashi Ebisawa

A Japanese health ministry panel on November 28 agreed on a plan to legally require pharma companies to set up…

By Ken Yoshino

Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving the…

A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…

A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…

Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

By Yoshinori Sagehashi

The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…