A recent conversation with a US biopharma senior director highlighted a critical talent gap: a strong demand for individuals with strategic management, critical thinking, and advanced business acumen-skills beyond traditional operational excellence. After the conversation, I rushed home and picked…
REGULATORY
MHLW Council Deems 11 “Loss” Products as Medically Highly Necessary
A council of the Ministry of Health, Labor and Welfare (MHLW) on May 9 determined that high medical needs exist for 11 so-called “drug loss” products, which will pave the way for development requests or sponsor invitations to be issued…
To read the full story
Related Article
- Industry Calls for More Tailored Govt Support on Drug Loss Product Development
July 16, 2025
- J-ENTRY Consortium Steps Up to Develop Two “Drug Loss” Products
July 9, 2025
- MHLW Seeks Development Sponsors for 5 “Drug Loss” Products
May 21, 2025
- MHLW to Help Match Domestic Firms with Overseas Originators to Fight Drug Loss
May 12, 2025
- Japan to Buttress Regulatory Communication Efforts for Drug Originators Overseas
April 25, 2025
- Japan Picks 14 “Loss” Products as Drugs with Highest Priority for Development
April 2, 2025
- Japan Gets Down to the Business of Solving Drug Loss, New Scheme Begins with 78 Meds
November 26, 2024
- MHLW Lists Up 78 Drug-Loss Assets, Asks Makers to Report Any Hurdles in Development
October 28, 2024
- MHLW Proposes New Scheme for Development Requests to Fight Drug Loss
July 8, 2024
REGULATORY
- OTC-Like Drugs Flagged as Key Agenda Item by CEFP Members
July 29, 2025
- Post-Marketing Oversight and Regulatory Reviews Must Work as One, Says New MHLW Safety Chief
July 29, 2025
- Astellas Employee Did Not Appeal, Prison Sentence Finalized in China
July 29, 2025
- Japan Panel Urges Consolidation of Cancer Surgery, Radiotherapy amid Shrinking Surgeon Workforce
July 29, 2025
- Two Oral Drugs Found to Exceed ADI for Red No. 3, MHLW Reports
July 28, 2025
In the race to develop next-generation antibody therapies for solid tumors, antibody drug conjugates (ADCs) are surging, while T-cell engagers…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
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…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
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…