Positive clinical results pave path forward for Japanese firm’s potential istradefylline successor.

Clinical trial sponsors can obtain valuable support from contract research organizations (CROs) but nonetheless remain liable for the conduct of their trials. Sidley Austin partner Dorothee Schramm and senior associate Katie von der Weid, both specialized in international commercial disputes, share tips to protect against common problems that can arise during the course of clinical trials.

With gene editing making the news again after the recent Nobel Prize for CRISPR, China’s EdiGene has been raising new funds to accelerate its pipeline to the clinic, led by a potential one-time cure for thalassemia and helped by recent regulatory changes.

Teva, Sun and the AAM are among those urging the CMS to rescind its proposal to reimburse Part B drugs approved under section 505(b)(2) as multiple source products. The proposal would target one relatively small but growing part of Medicare Rx spending and reflects CMS’ ongoing concern with fast rising costs in the program.