Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Nektar looks for the positive in a failed PhIII breast cancer study

About two months ago, Nektar was talking up a big expansion, making way for the new staffers that would be needed to start commercializing the breast cancer drug NKTR-102. Today, the biotech may be rethinking that plan, as the drug failed in a pivotal late-stage study.

Combo-happy Diamyd launches new diabetes vaccine trial in children

Diabetes vaccine developer Diamyd Medical is running a Phase II test to see if its candidate, Diamyd, can prevent or delay the onset of Type 1 diabetes in children at very high risk of presenting with the disease.

Analyst: Ebola vaccine developers 'need to weigh risks' as cases dwindle

The number of Ebola cases in West Africa has been declining, which has made it more difficult to enroll patients for clinical trials of leading vaccine candidates. And the way GlobalData analyst Daian Cheng sees it, that means it's time for vaccine manufacturers to "weigh the risks and benefits of developing further interventions for a disease that goes through unpredictable cycles of intense outbreaks followed by its virtual disappearance."

Acadia craters as takeover buzz is silenced by (another) NDA delay, CEO exit

San Diego-based Acadia Pharmaceuticals put out word on Wednesday evening that it is delaying its expected NDA for pimavanserin from Q1 back to some time in the second half of this year. And the company says its CEO is out the door.

U.K. academics move cell-gene lung cancer therapy into clinic

A team of London-based academics is set to trial a stem cell-delivered gene therapy in patients with lung cancer. The 56-person trial is the first time a stem cell-gene therapy combination has been tested in humans in the U.K.

Eyeing an FDA filing, Ocular Therapeutix drug hits PhIIIa goals

Ocular Therapeutix says that its lead eye therapy successfully wrapped the first of two Phase III studies, reducing inflammation and pain among a group of patients after cataract surgery. And with the second late-stage trial due to report out in a matter of weeks, the biotech says it remains on track to file for an approval in Q2.

Baxter and its controversial partner CTI claim a win in PhIII blood cancer study

Baxter and CTI BioPharma say they have come up with statistically significant topline data on the effectiveness and safety of pacritinib, their late-stage therapy for myelofibrosis. But after the biotech's many twists and turns taken trying to advance pixantrone over the years, a few longtime observers preferred to wait and see the actual numbers before deciding for themselves.

J&J, Merck to advance Ebola vaccines in Africa, but their fate rests in WHO's hands

Johnson & Johnson is ready to start trialing its Ebola vaccine in Africa, where Merck and NewLink are preparing to take theirs into Phase III. GlaxoSmithKline is also testing its jab there. But while thousands of healthcare workers have volunteered to participate in Ebola vaccine trials, the decision to mass-vaccinate against the disease is still up in the air.

Aduro, BMS cancer vaccine combo to start Phase II

In another step forward for cancer vaccine combos, Aduro Biotech announced Thursday that an investigator-led Phase II trial of its GVAX and CRS-207 for pancreatic cancer with Opdivo, Bristol-Myers Squibb's PD-1 drug, would begin.

Amgen hands off an IL-15 drug--strings attached--for upstart effort on celiac disease

A week after first raising the flag on their newborn biotech, a pair of entrepreneurs unhatched a deal today to take down a drug program that has been gathering dust on Amgen's R&D shelves for the past 7 years and test it as a new treatment for celiac disease.