Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.

Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.

Unsuccessful attempts to use real-world evidence for approvals highlight the need to demonstrate relationship between real-world data and clinical trial patients. The Pink Sheet examines what went wrong for Bluebird/Bristol’s Abecma, Ultragenyx’s Dojolvi, and Karyopharm’s Xpovio.

The number of approvals under a South Korean fast-track scheme launched around two years ago has increased, led more recently by COVID-19 vaccines and treatments, as well as anticancer drugs. Meanwhile, a new breakthrough therapy program similar to that in the US has been introduced to prioritize and speed up regulatory reviews of innovative medicines.