Tag:

clinical trials

Latest Headlines

Latest Headlines

Tonix's sublingual formulation for fibromyalgia reaches pivotal trial stage

Tonix Pharmaceuticals has completed enrollment in the 200-patient, placebo-controlled BESTFIT trial of sublingually delivered cyclobenzaprine for the treatment of fibromyalgia. 

Mouse model could have predicted drug toxicity that killed 5 in clinical trial

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.

NCI plans database of patients who experience miraculous recoveries

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."

Pharma continues to grapple with trial participants' use of social media

While it is years now since clinical trial participants started talking about their experiences online, the industry is still searching for the best way to approach the phenomenon. And with pharma needing to improve the clinical trial process, the onus is on the industry to find systems that not only manage the negative implications of social media, but tap into its power, too.

Europe to create public clinical trial results database after passing law

The European campaign for greater clinical trial data transparency faced a big test this week when the region's politicians voted on legislation. More than 95% voted in favor of the regulations, paving the way for the creation of a publicly-accessible database of clinical trial results.

Novartis' pitch to join trial data sharing bandwagon gets frosty reception

Johnson & Johnson was cautiously lauded for its clinical trial data-sharing initiative, but Roche's project was pilloried. Now Novartis has joined its Swiss peer in rolling out an underwhelming transparency program.

CamNtech gets an FDA nod as wearable devices advance into clinical trials

Clinical trial data collection has evolved slowly over the past two decades from site visits and paper questionnaires to telemedicine and electronic patient reported outcomes. The transition is far from complete though, with the likes of CamNtech and Medidata now looking to bring wearable computers to clinical trials.

Ariad halts Iclusig trial enrollment on blood-clot worries

After investigators tracked a rising rate of blood clots among leukemia patients in ongoing clinical studies, the biotech slammed the brakes on new trial enrollment and rolled out a lower dosing schedule for current participants.

Nanoparticles made from grapefruit lipids deliver drugs safely

Using lipids derived from grapefruits, researchers at the University of Louisville have created nanoparticles for drug delivery that are less toxic to both people and the environment and may offer a less expensive alternative to synthetic materials.

Elixir bolsters recent CE mark with successful pivotal trial

Less than a week after securing a CE mark for its DESolve drug-eluting stent, Elixir Medical reported successful results in a pivotal trial of the same device, which should reach the market by the end of this year.