Applied Clinical Trials Digital Edition - April/May 2015

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Viatris reported that its MR-139 ophthalmic ointment failed to meet its primary endpoint in a Phase III blepharitis trial, while advancing its MR-141 and MR-142 candidates in presbyopia and night vision impairment with positive late-stage results.

Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and highlights global momentum behind Blenrep combination approvals.

New data from the VOLITION study reveal that 89% of treatment-naïve individuals with HIV chose to switch to long-acting cabotegravir and rilpivirine after achieving viral suppression with oral DTG/3TC, with real-world evidence further supporting its effectiveness across diverse populations.