Japan's latest batch of new drug approvals includes the country's second CAR-T therapy, along with multiple oncology drugs and a novel migraine treatments, which should all reach the market in the next few months following reimbursement price listing.
The latest batch of product approvals in Japan includes Daiichi Sankyo Co., Ltd.’s CD19-targeting cancer therapy Yescarta (axicabtagene ciloleucel), making this the second chimeric antigen receptor (CAR) T-cell treatment to be cleared for marketing in the county.
Yescarta, which the Japanese firm licensed from originator Kite Pharma, Inc. (now part of Gilead Sciences, Inc.) in...
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.
