Vivus completes protocol assessment for Phase III studies of Luramist
Under the special protocol assessment (SPA), the company and the FDA have agreed to design features for the pivotal Phase III efficacy studies including the primary endpoints, the
BeOne Medicines is set to invest $300m in expanding its manufacturing and research operations at the Princeton West Innovation Campus in Hopewell, New Jersey, US.
Pursuant to the special protocol assessment, the Phase III trial will be a randomized, double-blind, placebo-controlled trial of CB7630 plus prednisone in patients with metastatic castration-resistant prostate cancer
This orphan designation qualifies the company and it’s Neo-Bladder Augment for European Medicines Agency (EMEA) regulatory incentives, including eligibility for protocol assistance and possible exemptions or reductions of