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 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.
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.
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 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.
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'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.
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).
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.
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.