MSD’s new pulmonary arterial hypertension (PAH) therapy Airwin (sotatercept) hit the Japanese market in mid-August. It’s the kind of launch…
BUSINESS
Otsuka Files NDA for Lupus Nephritis Drug in Japan
Otsuka Pharmaceutical said on November 10 that it has filed a new drug application for its oral immunosuppressant voclosporin for the treatment of lupus nephritis in Japan.A calcineurin inhibitor, voclosporin was developed by Canada’s Aurinia Pharmaceuticals, which received US FDA…
To read the full story
Related Article
- Japan Panel Clears Amgen’s TED Med, Rexulti for Alzheimer’s Agitation and More
August 28, 2024
- Eisai’s ALS Therapy, Amgen’s TED Drug Up for Review on Aug. 26
August 19, 2024
- Otsuka’s Lupus Nephritis Med Lupkynis Wins European Greenlight
September 21, 2022
- Otsuka Gets EU Panel Backing for Lupus Nephritis Drug
July 25, 2022
BUSINESS
- Nichi-Iko Shows Signs of Recovery but Restructuring Still Underway: CEO
September 5, 2025
- And Pharma Chief Pledges Growth Strategy as New Generics Holding Firm Takes Shape
September 5, 2025
- New Study of Vasomune-Partnered AV-001 Cleared in Canada: AnGes
September 5, 2025
- Keytruda Top-Selling Drug in Japan for 23 Months Running: Encise
September 5, 2025
- Eisai Begins FDA Rolling Submission for Leqembi SC for Starting Dose
September 4, 2025
Leftover stocks of high-priced medicines are emerging as a serious headache for Japanese pharmacies, fueling financial stress and even bankruptcies…
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…