When the early-stage CRO PRACS Institute filed for Chapter 7 bankruptcy late last week, suddenly dismissing hundreds of workers and leaving their trial subjects unpaid, the company left a Who's Who of the biopharma industry on its list of creditors as dozens of trials suddenly ground to a halt, unfinished.
The company didn't spell out the data, but it made clear that the drug failed to hit the primary endpoint of progression-free survival--prompting executives to call for the budget ax.
More and more research universities are jumping into the CRO game, using their existing labs and expertise to launch moneymaking operations. Duke University's clinical research unit has signed on with Benitec Biopharma to run Phase I/II trials for an RNAi hepatitis C drug.
Genzyme executives today rolled out positive data from a one-year extension study of its pivotal Phase III trial that gives the company some boasting rights for a drug that demonstrated a durable response in most patients.
Shares of San Diego-based Acadia Pharmaceuticals surged 28% this morning after the biotech spelled out some of its Phase III data on pimavanserin, its experimental therapy for treating psychosis in Parkinson's patients.
Teva and its multiple sclerosis partner Active Biotech rolled out some new top-line Phase III data on their troubled program for the oral multiple sclerosis drug laquinimod--still Teva's best shot at protecting the $4 billion franchise built up for Copaxone.
In a mid-stage study involving more than 400 children in Kenya investigators say that the RTS, S vaccine delivered a 43.6% efficacy rate in the first year and then plunged, falling to zero by the fourth year.
A tiny new study involving 5 patients with an acute and typically terminal case of relapsed leukemia has provided a few high-profile testimonials for a new and promising gene therapy strategy.
Shares of Israel's BioLineRx plunged 51% this morning when the biotech announced that it was shutting down a Phase II/III study for an experimental schizophrenia treatment--its lead program--after an interim analysis forced the company to acknowledge that investigators were headed for a failure.
Gilead Sciences has invoked Cancer Genetics to head up international clinical trials in an effort to diagnose patients with chronic lymphocytic leukemia.