The first-in-class anti-CLDN 18.2 antibody zolbetuximab will face cost-effectiveness assessment in Japan in the near future, as the country applies stricter reimbursement pricing policies to gain transparency in expenditure through its healthcare reimbursement structure.
Japan’s Ministry of Health, Labour and Welfare (MHLW) has announced its latest list of reimbursement prices for recently approved drugs, including for products which obtained their global-first approval in March.
In this round, most of the new drugs were granted various forms of pricing premiums, while several including Nobelpharma...
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting reimbursement prices. How has the sector panned out over the last decade?
A Japanese approval for Lilly's Alzheimer's drug donanemab is expected soon following a positive recommendation from the MHLW. The ministry has also announced reimbursement prices for 12 new products including Fabhalta, along with price cuts for Tezspire, Dupixent and competitors following a review.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
