One of the programs involved in AstraZeneca's $50 million bid to collaborate with Amgen on the development of a slate of biologics has run into a snafu of some sort. Late last summer investigators reported that a pair of mid-stage trials of AMG 181 for ulcerative colitis and Crohn's disease had been suspended, just after an early-stage trial was reported terminated.
Sanofi and Regeneron have rolled out promising Phase III data on their cholesterol drug alirocumab, which handily breezed by Merck's Zetia in lowering bad LDL cholesterol. The partners are in a high-stakes race to win the first regulatory approval for a PCSK9 inhibitor.
Coronado Biosciences' mid-stage trial of its experimental drug for Crohn's disease flopped in a mid-stage study. And while the biotech pointed to an unexpected placebo response and the possibility of finding something positive after some further analysis of the data, its stock cratered on the news, plunging 70%.
Parexel International has inked a deal to pool its clinical trial data management service with a Japanese provider, teaming up to expand its share of the local market.
Irish CRO Icon is riding the spike in demand for adaptive trial monitoring, unveiling a new service that parses study data and highlights potential safety issues in real time.
Like many top-tier schools, Yale University has a wealth of expertise and capability in clinical research, and now, citing demand for medical device studies, the Ivy League institution has teamed up with a CRO to land more trial contracts.
Lundbeck and its partners at Otsuka are embarking on a lengthy Phase III journey in search of solid evidence that their Alzheimer's drug Lu AE58054 in combination with donepezil can improve the swiftly eroding cognitive functions of Alzheimer's patients.
Just weeks after sending in an application to the FDA seeking approval to start marketing its PI3k-delta inhibitor idelalisib for non-Hodgkin's lymphoma, Gilead ($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.