Biogen and Eisai End Three More Alzheimer’s Studies

September 16, 2019

Biogen and Eisai announced this week that they are pulling the plug on three additional phase 3 Alzheimer’s trials of investigational oral beta amyloid therapies (BACE inhibitors) over safety concerns.

FDA Recommends Endpoint for Hormone Analogs for Prostate Cancer

July 22, 2019

Testerone level should be used as a surrogate endpoint in phase 3 trials of gonadotropin-releasing hormone (GnRH) analogs for treating advanced prostate cancer, the FDA says in a new draft guidance.

Sponsors should conduct single-arm trials that measure attainment and maintenance of castrate testosterone (T) levels, according to the draft guidance released last week. Trials should look at T levels maintained until the end of a dosing interval as well as immediately after later doses — not the first dose — of the study drug.