Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Amgen successfully hits another PhIII goal line with kidney dialysis drug

Amgen successfully wrapped its second Phase III study for AMG416, its late-stage drug for secondary hyperparathyroidism that's now one final study away from a prospective regulatory filing.

Chikungunya vaccine shows antibody response in Phase I trial

Following recent outbreaks in the Pacific and Caribbean, chikungunya virus has made its way to the U.S.--and drug developers have taken note of its continued spread.

AstraZeneca squares off against Roche in blockbuster PhIII asthma showdown

AstraZeneca has launched a Phase III test of its targeted IL-13 asthma drug tralokinumab, beefing up its late-stage pipeline for respiratory diseases and squaring off against some major league competition now in the clinic.

AstraZeneca clears some key PhIII hurdles with lesinurad gout combos

AstraZeneca had some upbeat news to report Wednesday morning, noting that a slate of key Phase III combination studies for the gout drug lesinurad crossed the finish line with positive results for three out of four primary endpoints, raising hopes that the once star-crossed pharma giant may be on the verge of a blockbuster approval. And the company says it plans to push ahead with regulatory applications with the late-stage data now in hand.

Hype and hope compete as overnight stardom engulfs untried Ebola drugs

It's not often that the president of the United States is asked to weigh in on whether an experimental drug should be OK'd for human use ahead of human trials. But when it comes to an outbreak of a lethal virus--even one that's been percolating in equatorial Africa for decades--everything is potential fodder for reporters operating in a 24-hour news cycle.

Cytori shares slammed as safety concerns halt stem cell trials

Cytori Therapeutics hit the brakes on a pair of clinical trials to find out why three patients in the study suffered from "cerebrovascular" events after they were treated with the biotech's experimental stem cell treatment. The San Diego-based biotech's shares plunged more than 30% in after-hours trading after putting out word of the hold in a late release.

Insmed shares shrivel as PhIII Arikayce plan chills hopes for quick OK

The news at Insmed tends to run hot and cold for investors. When their experimental antibiotic Arikayce hits trouble, its stock price goes cold and shrivels. Good news runs hot on the market. On Monday, though, the share price plunged after the biotech laid out plans for a lengthy pair of late-stage studies, squashing hopes for a quick dash to the FDA for an early approval.

NIH: Ebola vaccine trial could begin as early as September

The U.S. National Institutes of Health is set to begin an early-stage clinical trial for an Ebola vaccine in September, according to reports.

Biota tanks as its flu drug comes up empty in Phase II

Biota Pharmaceuticals' slow trip downward continued Friday as the company disclosed that its its lead program, a flu treatment called laninamivir octanoate, failed to beat out placebo in a midstage study, sending its shares to an all-time nadir.

UPDATED: Targacept's litany of trial failures continues with yet another flop

On Monday, Targacept reported that its midstage effort aimed at salvaging its lead drug flopped. Once partnered with AstraZeneca, which saw four late-stage studies for the one-time depression drug TC-5214 hopeful sour, Targacept says it's finally ready to dump the therapy after it failed in a Phase IIb study for overactive bladder.