Topic:

Clinical Trials

Latest Headlines

Latest Headlines

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.

AstraZeneca inks deal with Advaxis for immunotherapy-vaccine combo trial

AstraZeneca's MedImmune has joined up with immunotherapy maker Advaxis to evaluate the Big Pharma's antibody MEDI4736 in conjunction with the Princeton, NJ-based biotech's lead cancer vaccine in patients with HPV-related cancers.

Puma shares triple on positive PhIII neratinib data, plans to file for approval

Shares of Puma Biotechnology soared more than 220% after the markets closed on Tuesday as investors cheered the biotech's positive Phase III numbers for a late-stage study of their lead drug neratinib (PB272). 

Roche is at an Alzheimer's crossroads after mixed data for AC Immune's drug

An Alzheimer's treatment from AC Immune and Genentech posted mixed results in a midstage study, missing its coprimary endpoints but performing well in patients with milder symptoms. That leaves Roche, Genentech's parent company, with a big decision to make on whether to take the plunge into Phase III.

Solid PhIII brings Sanofi closer to blockbuster dengue sales

A new batch of results from a large-scale Phase III trial of Sanofi's dengue candidate holds mostly good news for French drugmaker, which is on track to produce the world's first vaccine for the deadly disease. But while the candidate showed itself to be by-and-large safe and effective, it once again faltered against serotype 2, the same variant that tripped it up in an earlier trial.

Regeneron, Sanofi herald a blockbuster contender with groundbreaking study

If you want to understand why Regeneron R&D chief George Yancopolous gets a king's ransom in annual compensation, you need look no further than the Phase IIb data that has just been posted on dupilumab for severe eczema.

Alzheimer's R&D suffers as trial failure rate hits an 'astounding' 99.6%

Jeffrey Cummings is directing one of the few early-stage studies underway on an Alzheimer's therapy. And now that he's scanned the records of clinicaltrials.gov, he's acutely aware of just how small his chosen field is.