Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted marketing authorizations for a large group of new drugs that included several world-first clearances for therapies in ulcerative colitis, dermatology and rare diseases.
Carogra, Xenpozyme Among Japan World-First Approvals
The latest batch of new drug approvals in Japan includes several products receiving their first marketing clearances globally, notably a new oral competitor to a blockbuster ulcerative colitis drug and a high-need therapy for the rare disease ASMD.
More from Japan
• By
Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
• By
Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.
• By
Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.
• By
A plan to reduce benefits under Japan's financial safety net for patients contributing to the costs of their long-term medical care is being reconsidered by the government following protests from patient and doctor groups.
More from Asia
• By
Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.
• By
While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
• By
The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.