Fierce 15 member Intersect ENT said a study of its bioabsorbable steroid-releasing sinus implant met its primary endpoint, as the company seeks to expand the indication of its drug delivery tech to include placement in the frontal sinuses, located behind the eyebrows.
Only 13% of clinical trials registered at ClinicalTrials.gov posted their results within one year of data collection, as required by federal law, according to a study in The New England Journal of Medicine.
Improved access by researchers to corporate clinical trial data, much like open-source software, is expected to help facilitate a conversation between academia and the business world that could both facilitate translational research and help to validate corporate research. Yale University and Johnson & Johnson have announced the first such deal to enable external investigator access to medical device and diagnostics clinical data from J&J.
A group of hackers is looking for information related to drug safety, clinical trials, regulatory decisions and legal issues that's significant enough to move the global financial markets--and it's raiding top pharma execs' email accounts to find it, The New York Times reports.
A study published Sept. 29 in The Journal of the American Medical Association concluded that publicly available information to support the safety and effectiveness of implanted, 510(k)-cleared devices is lacking.
The federal Patient-Centered Outcomes Research Institute added three medical device-related topics to its list of priority research areas that are eligible for enhanced funding under the Pragmatic Clinical Studies initiative. In the new funding round, comparative trials studying cardiology, hip fracture and surgical mesh are invited to apply.
A Wall Street Journal feature this week on researchers' long-standing concerns about the consequences of patients talking about clinical trials online digs into how biopharma companies are tapping technology to counter concerns about unblinding and manipulating inclusion/exclusion criteria.
Tonix Pharmaceuticals has completed enrollment in the 200-patient, placebo-controlled BESTFIT trial of sublingually delivered cyclobenzaprine for the treatment of fibromyalgia.
In a 1993 clinical trial of fialuridine--a drug originally designed as a therapy for hepatitis B--5 out of 15 patients died from sudden liver failure. A new study in PLOS Medicine found that mice with humanized livers demonstrate the drug's toxicity.
Every clinical trial has its outliers. Some patients respond far better to the treatment than the rest, but the focus on efficacy across the study population means these results--and their implications--are lost in the shuffle. The National Cancer Institute is trying to change this by improving the tracking of data on these "exceptional responders."