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Spectrum Pharmaceuticals failed to impress an FDA advisory committee, which unanimously voted against recommending approval of the company’s treatment to prevent recurrence of low-grade non-muscle invasive bladder cancer. Read More
The FDA confirmed the use of total kidney volume measurements in selecting patients for clinical trials in autosomal dominant polycystic kidney disease. Read More
Kite Pharma announced positive interim results from a Phase II clinical trial of its immunotherapy in patients with aggressive non-Hodgkin’s lymphomas and said the study would form the basis of its marketing submissions to the FDA. Read More
Three pharmaceutical companies announced Phase III trial results from their injectable psoriasis treatments — with one delivering better head-to-head clinical results than international top-selling drug Humira, which reached over $14 billion in sales in 2015. Read More
To achieve the national cancer moonshot’s goal of accelerating cancer research, the FDA is planning to encourage more seamless, adaptive clinical trial designs for oncologic drugs. Read More
The expanded HHS mandate that clinical trial investigators publish their full results on ClinicalTrials.gov is backed up with strong consequences for non-compliance that will be enforced by the FDA and the National Institutes of Health. Read More
Juno Therapeutics has been sued in a class-action lawsuit alleging that the company violated federal securities law by failing to disclose a death during a clinical trial. Read More
Plasma fibrinogen can be used as a biomarker in interventional clinical trials examining patients at high risk for exacerbations or all-cause mortality in chronic obstructive pulmonary disease, according to final guidance to industry issued by FDA. Read More
A German agency criticized a report on the EMA’s adaptive pathway, taking the agency to task for leaving stakeholders in the dark on use of real-world evidence. Read More