Japan’s fast-track approval system for innovative drug candidates has marked its seventh year since launch, during which it has accepted 27 candidates with 13 of these moving to approval. But in recent years the system has faced a decreasing number of admitted candidates, this original infographic analysis shows.
Since Japan introduced its "Sakigake" pioneering therapy review and approval scheme on a pilot basis in 2015, a total of 27 products have been admitted, with 11 moving through to their first approval globally, including several innovative new treatments for oncology and rare diseases.
However, the system has seen a decreasing number of candidates over its five rounds ending in 2020 before it officially...
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.
