Like many top-tier schools, Yale University has a wealth of expertise and capability in clinical research, and now, citing demand for medical device studies, the Ivy League institution has teamed up with a CRO to land more trial contracts.
Lundbeck and its partners at Otsuka are embarking on a lengthy Phase III journey in search of solid evidence that their Alzheimer's drug Lu AE58054 in combination with donepezil can improve the swiftly eroding cognitive functions of Alzheimer's patients.
Just weeks after sending in an application to the FDA seeking approval to start marketing its PI3k-delta inhibitor idelalisib for non-Hodgkin's lymphoma, Gilead ($GILD) says it has wrapped a Phase III study of the drug early because of the extremely promising progression-free survival data that had been gathered for previously treated chronic lymphocytic leukemia, one of the most common blood cancers.
Ariad Pharmaceuticals slammed the brakes on new trial enrollment and rolled out a lower dosing schedule for patients in a slate of ongoing studies of Iclusig (ponatinib) after investigators tracked cardiovascular events among a significant group of leukemia patients.
When NIH canned its HIV vaccine trial in April, the field, yet again, lost its brightest hope. Since then, NIH has continued to monitor participants in the trial, and this week it presented an update in the New England Journal of Medicine.
John Kraus, GSK's medical leader for drisapersen, unveiled more data from the failed study on the exon-skipping technology, which fell short not only on its primary endpoint for improved walking distances in a 6-minute test but also flunked out on three separate secondary endpoints, with the outcomes looking almost identical in each case with a placebo.
Pain drugs aren't easy to develop. Investigators have often had to struggle to design a trial that could effectively demonstrate a new treatment's efficacy to the FDA's satisfaction.
When Takeda bought LigoCyte Pharmaceuticals last year, it hitched the near-term fate of its nascent vaccine unit to a jab for the vomiting and diarrhea bug, norovirus. This week, exactly one year after moving to buy LigoCyte, Takeda revealed the vaccine missed its primary endpoint in an early-phase trial.
The National Institutes of Health normally enrolls about 200 patients a week in ongoing trials of experimental therapies. Now, with about 73% of NIH staff sitting at home, the agency can't begin any new studies, forcing researchers to turn patients away.
Quintiles, the world's largest CRO, has launched a study to determine whether preprofiling cancer patients for key biomarkers can ease trial enrollment and speed drug development.