Pointing to what it says is decreased R&D in Japan in contrast to the global market, PhRMA has again urged the country to revise its drug pricing policies and support innovation, while cautiously welcoming new moves to waive a requirement for Phase I trials in the country.
The US innovation-based industry association, Pharmaceutical Research Manufacturers of America (PhRMA), has again called on Japan to reform its unpredictable and frequent reimbursement price-cutting policies for prescription drugs and to direct more funding and support to innovation in the national biopharma industry.
During a recent visit to the country for the group's annual PhRMA Week meetings with government officials, chairman Vasant Narasimhan...
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.
