Japan approves a large batch of new products including significant first nods globally for AbbVie's antibody for psoriasis and Japan's first gene-based therapy, as well as a pioneering first approval in Asia for a CAR-T drug.
The latest batch of product approvals in Japan includes the first to be granted anywhere globally for AbbVie Inc.'s anti-interleukin-23 antibody Skyrizi (risankizumab), as well as nods for Japan’s first gene-based therapy and a pioneering marketing clearance in Asia for a CAR-T drug, Novartis AG's Kymriah.
Skyrizi, being developed globally in a collaboration with Boehringer Ingelheim GmbH, was approved for plaque psoriasis, generalized pustular psoriasis,...
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.
