Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
REGULATORY
Japan Health Ministry Panel Gives Blessing to Novartis’ PNH Drug Iptacopan and More
A key health ministry advisory panel gave its thumbs-up to Novartis Pharma’s paroxysmal nocturnal hemoglobinuria (PNH) therapy iptacopan, known as Fabhalta overseas, among other medicines on May 31. Novartis’ product was one of the four new molecular entities (NMEs) that…
To read the full story
Related Article
- Japan Approves Novartis’ Fabhalta, Lilly’s Jaypirca, and Lots More
June 25, 2024
- Tapinarof Cream Hits Main Goal in PIII Eczema Trial in Children: JT/Torii
June 3, 2024
- Novartis’ Fabhalta, Novo’s Awiqli, and More Up for PAFSC Review on May 31
May 20, 2024
- JT Files Tapinarof Cream for Eczema, Psoriasis in Japan
September 19, 2023
- AbbVie Files Skyrizi for Ulcerative Colitis in Japan
September 15, 2023
- Novo Nordisk Files Once-Weekly Basal Insulin in Japan
August 10, 2023
- UCB Submits Anti-Epileptic Drug Brivaracetam in Japan
July 31, 2023
REGULATORY
- Japan to Buttress Regulatory Communication Efforts for Drug Originators Overseas
April 25, 2025
- “Time to Revise” Fee Premiums for Generic Use: Chuikyo Payer Rep
April 25, 2025
- MHLW to Present Estimate on Coverage Removal of OTC-Like Meds at 3-Party Talks
April 24, 2025
- MOF’s Spring Debate Puts Special Focus on CEA, More Aggressive Re-Pricing Eyed
April 24, 2025
- Epkinly to Face Price Cuts under CEA Scheme
April 24, 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…