For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
REGULATORY
Puberulic Acid Determined as Cause of “Beni-Koji” Health Damages
The Ministry of Health, Labor and Welfare (MHLW) said on September 18 that the flurry of kidney damages reported for Kobayashi Pharmaceutical’s “beni-koji” dietary supplements were found to have been caused by “puberulic acid” produced from blue mold. It was…
To read the full story
Related Article
- Kobayashi Pharma Replaces Management after Beni-Koji Scandal
July 24, 2024
- More Unexpected Substances in Kobayashi’s Beni-Koji Supplements: MHLW
April 22, 2024
- Fanconi Syndrome Found in Majority of Health Damages Tied to Beni-Koji Supplements
April 10, 2024
- Kobayashi Factory Inspected over Beni-Koji Health Issue
April 1, 2024
- “Puberulic Acid” in Beni-Koji Supplements; Kobayashi Wants to Keep Healthcare Biz
April 1, 2024
- Beni-Koji Issue: MHLW Requests Self-Inspections to Purchasers of Kobayashi’s Red Rice Yeast
March 29, 2024
- Japan Govt Launches Panel to Respond to Red Yeast Rice Issue
March 28, 2024
- One Dead after Taking Kobayashi’s Red Yeast Rice Pills
March 27, 2024
- Kobayashi’s Beni Koji Health Damage Reports Trigger Knock-On Recalls
March 27, 2024
- Hospitalized Cases Tied to Kobayashi Pharma’s Supplements Now Up to 26
March 26, 2024
- Kobayashi Pharma Recalls Supplements on Reports of Kidney Disorders
March 25, 2024
REGULATORY
- MHLW Issues Guidance on Early Approval Scheme for MCMs
November 8, 2024
- Chuikyo Supports Full Rollout of Company Indices for Generics Manufacturers
November 7, 2024
- Chuikyo Doubts Effect of Re-Pricing for Unprofitable Products
November 7, 2024
- Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
November 5, 2024
- PMDA Opens US Office in Washington, D.C.
November 5, 2024
Japan introduced a new health coverage scheme for long-listed products (LLPs) on October 1. A survey of generic drug makers…
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…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…