Japan adds a batch of new drugs, including Wegovy, to the national health insurance reimbursement tariff, but discussions over Leqembi for Alzheimer’s are still ongoing, with indications that repricing could be possible if demand expands quickly.
Among the most notable new drugs in Japan's latest listing of reimbursement prices are Novo Nordisk A/S’s blockbuster obesity therapy Wegovy (semaglutide), Chugai Pharmaceutical Co., Ltd./Roche Holding AG’s Phesgo (pertuzumab/trastuzumab/hyaluronidase) for breast cancer and UCB S.A.’s myasthenia gravis treatment Zilbrysq (zilucoplan).
Along with the new tariff inclusions under the country’s national health insurance (NHI) scheme, effective 22 November, authorities also announced...
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.
