ERT Introduces Express Overread Service for Respiratory Clinical Trials

Company opts not to advance VX-993 into pivotal development after Phase II data show no statistically significant benefit over placebo in post-bunionectomy surgical pain relief.

In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how these proposals could jeopardize both participant safety and future innovation.

New results from the Phase III Portal extension study show that Susvimo maintained vision and disease control over five years in neovascular AMD, with 95% of patients requiring no supplemental treatment between six-month refill intervals.

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.

Clinical trial failure insurance is turning biotech’s most costly risk into a manageable asset, opening new pathways for funding and innovation.

In the BOHEMIA study, once-monthly ivermectin over 3 months significantly reduced malaria incidence versus albendazole in children aged 5 to 15 years, supporting its role as a novel vector-control tool amid rising insecticide resistance.