Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
REGULATORY
Japan OKs Enhertu, 3 Sakigake Drugs, Beovu, Latuda, and More
The Ministry of Health, Labor and Welfare (MHLW) on March 25 gave the green light to a slew of new medicines, including Daiichi Sankyo’s cancer drug Enhertu (trastuzumab deruxtecan) and Novartis’ Eylea (aflibercept) rival Beovu (brolucizumab). The MHLW granted conditional…
To read the full story
Related Article
- Daiichi Sankyo’s Enhertu Hits Japan Market for Breast Cancer
May 26, 2020
- Daiichi Sankyo’s Enhertu, Novartis’ Beovu, Novo’s Ozempic OK’ed for Listing on May 20
May 13, 2020
- MHLW Panel Clears Latuda, 1st Japan-Originated Oligonucleotide; Approval Expected in March
March 2, 2020
- Daiichi Sankyo’s Enhertu Clears MHLW Panel, Conditional Nod Expected in March
February 27, 2020
- MHLW Panel Backs Approval of Sakigake-Designated BNCT Radiation Therapy System
February 20, 2020
- Takeda’s RCC Drug Cabometyx Now in Line for March Approval; Alecensa, Rozlytrek Opdivo and More
January 30, 2020
- MHLW Panel Gives Thumbs Up for Novartis’ ADM Med Brolucizumab for Approval in as Early as March
January 29, 2020
REGULATORY
- MHLW Panel to Discuss Approval of ASKA’s Contraceptive Pill and More on April 25
April 18, 2025
- Lower House Health Committee OKs Bill to Amend PMD Act, Adopts Supplementary Resolution
April 17, 2025
- MHLW Provides Draft Policymaking Document for Off-Year Revision after Opposition’s Call
April 17, 2025
- MHLW Looking into Impact of US Tariffs, Seeks Drug Makers’ Support
April 17, 2025
- MHLW to Revise Patent Linkage Scheme in FY2025, Create Expert Committee
April 16, 2025
Your company’s employer brand is your reputation as an employer and is crucial in attracting top talent. Some reputations are just not good; they may or not be deserved. That is just the perception in the market. Years ago there…
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…