Oxford-based PsiOxus Therapeutics came through with a slate of mostly upbeat results from its mid-stage study of its lead drug MT-102, an experimental therapy designed to combat potentially lethal weight loss among cancer patients.
Troubled Dendreon is again cutting its payroll, planning to shed about 200 employees in an effort to water down its cash burn rate and finally turn a profit. But, with a disappointing prostate cancer drug and a dim outlook for the future, the Seattle drugmaker may need more than lighter books to reverse its fortunes or find an acquirer.
The drug--designed to correct the circadian rhythms of the blind to ensure normal sleep patterns--worked as billed in the late-stage program for non-24 hour disorder, he wrote, and, given that there were no serious adverse events to consider, ought to be endorsed during an upcoming expert panel review and then approved by the agency.
In what has been one of the most hotly contested issues among biotech investors this year, many had bet big that the FDA would push through an accelerated approval for eteplirsen based on some very promising results from a mid-stage study. The study, though, only included a dozen boys, making the prospect of an early approval problematic at best.
The pharma giant reported that the drug did not produce a statistically significant improvement in the risk of heart attack, stroke or death, though it added that "greater reductions" for some of the secondary endpoints warranted careful follow-up review as investigators considered its potential.
The FDA has approved Sunovion's Aptiom (eslicarbazepine), an add-on therapy designed to prevent epilepsy seizures. "Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments," said Dr. Eric Bastings, acting director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.
GlaxoSmithKline has racked up a slate of drug approvals this year, an impressive accomplishment for a company that had to endure a lengthy fallow period in R&D after it reorganized its extensive research operations.
Over the past 5 years, the main arteries of drug R&D have pointed straight to the world's biggest biopharma hubs. As hubs have grown, outlying R&D operations have been steadily trimmed away.
A little more than a year since its last lead therapy bit the dust, Zalicus today reported that its new lead drug foundered in a pair of mid-stage studies and will join the company's growing scrap heap. The news triggered a rout on Wall Street, with shares in meltdown mode after the news hit.
Back in September, when Ultragenyx CEO Emil Kakkis was talking to FierceBiotech about the company for our annual Fierce 15 report, the biotech chief confidently predicted that he could take the company public next year.
The buyout--at $50 a share--will add Cinryze for hereditary angioedema to Shire's product lineup along with the experimental drug maribavir for cytomegalovirus, one of 8 clinical-stage programs in the pipeline.
After downsizing its sought-after haul, GlycoMimetics is postponing its $64 million IPO plans, a sign that the year's investor frenzy over biotech debuts may not be welcoming all comers.
Sanofi's multiple sclerosis drug Lemtrada may be too dangerous to warrant FDA approval, agency staff said, potentially damning news for an injection that has slogged through 25 years of back-and-forth development.
J&J has spent hundreds of millions of dollars in a so-far failed effort to develop a late-stage biologic that could be used to treat Alzheimer's. And it's now prepared to spend hundreds of millions more as it goes back to the drawing board to explore the molecular underpinnings of the disease in an attempt to find new therapies that promise to thwart the disease before it cripples the brain.
Bristol-Myers Squibb joined the lineup of biopharma companies executing R&D realignments today, announcing plans to cut back on some of its discovery work in three key disease areas and eliminate 70 to 75 positions in its R&D group as it concentrates resources on late-stage programs.
Ariad Pharmaceuticals is letting go of nearly half its U.S. staff just a week after pulling its leukemia drug Iclusig from the market at the FDA's request, an unsurprising next step in what has been a monthlong downward spiral for the Massachusetts biotech.
San Diego-based Sangart has gone missing in action after apparently burning through more than a quarter-billion dollars of Leucadia National cash.