Japan's latest batch of product approvals includes high-profile Alzheimer's drug Leqembi (lecanemab), along with Alhemo (concizumab) for hemophilia, Phozevel (tenapanor) for hyperphosphatemia and others. Eyes are now on the shape of use guidelines and monitoring requirements for Leqembi, along with how its extended NHI  reimbursement pricing process will develop. All going well, it could reach the market by the end of the year.

Japan's latest batch of product approvals includes high-profile Alzheimer's drug Leqembi (lecanemab), along with Alhemo (concizumab) for hemophilia, Phozevel (tenapanor) for hyperphosphatemia and others. Eyes are now on the shape of use guidelines and monitoring requirements for Leqembi, along with how its extended NHI  reimbursement pricing process will develop. All going well, it could reach the market by the end of the year.

Fourteen user fee goal dates are on the October calendar, including three novel agents, according to the Pink Sheet US FDA Performance Tracker.

Bristol aims to bring more drugs into the clinic as fast as possible without compromising on quality, with many novel molecules emerging from its productive protein degradation and cell therapy platforms.