Clinical Trials

The deadline is approaching for submissions to the 2023 Citeline Awards; gain recognition for your clinical research team, real world evidence project, diversity and inclusion efforts, and more. 

The US biotech’s lead candidate missed the mark in a Phase III hospital-related pneumonia trial due to low recruitment affected by macroeconomic headwinds but analysts retain high hopes for another upcoming study.

The confluence of data science and molecular biology fuels expectations among biopharma industry leaders for another year of breakthrough innovation in human therapeutics. More than 70 executives and experts reveal what they are most excited about on the technology front.

The diabetic retinopathy candidate failed on its Phase II primary endpoint, but showed efficacy on a key secondary endpoint that the company hopes to use as the Phase III primary outcome measure.

JAMA reports on the COVID-19 Prevention Network’s efforts. Also, Inhibikase said the US FDA lifted a hold on its drug for Parkinson’s disease, while Astellas Pharma said the agency lifted a clinical hold on its gene therapy for Pompe disease. And Trefoil, Theriva Biologics and Nektar initiated new trials.

The UK biotech will use the funds to advance the development of its first-in-class ERAP1 inhibitor, which could circumvent the limitations of poor tumor visibility and T cell exhaustion.

Scrip surveys the Phase III clinical trial readout landscape and picks 10 of the more interesting studies set to report in 2023, with a few added extras. AstraZeneca, Novo Nordisk, Novartis and Roche feature heavily.

With successful Phase III data, Merck will look to add biliary tract cancer to Keytruda’s label, but it will discontinue a Phase III study in prostate cancer after an interim analysis showed no survival benefit.

The US firm is touting top-line data from an open-label Alzheimer’s disease trial as a net positive, but the lack of p-values and a declining trend in efficacy left some investors and analysts lukewarm.

Drug makers have sought to branch into new frontiers of drug development in areas like cancers and neurology, but not all of them have been success stories. Here, Scrip looks at some of the more notable clinical trial misses of last year.

Hindsight is a wonderful thing but the saga of AstraZeneca's acquisition of CinCor is an eye-opener as SEC filings reveal that a $60 per share offer was rejected in September before a $26 bid won the day earlier this month.  

Any given year sees a variety of clinical trials produce positive or negative results. But some of those trials are especially important either for moving a field forward or for a company’s overall development and commercial strategy. Here, Scrip looks at some of the more notable trial successes of the last year.