Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Purdue preps potential Zohydro killer for FDA review after positive PhIII

As the commercial release of Zogenix's hydrocodone bitartrate pain drug Zohydro spawns headlines from coast-to-coast warning of a potential epidemic of abuse similar to what was seen with OxyContin, the rival Purdue Pharma says it has successfully wrapped a Phase III trial of its abuse-resistant competitor. And the data sets the stage for an FDA filing later this year as Zogenix labors at its own early-stage efforts at making a pain pill that's harder to abuse.

Geron shares blasted as FDA slams the brakes on imetelstat studies

Geron is back in the tank. The biotech's shares were in meltdown mode Wednesday morning, plunging about 60% in premarket trading after the company announced that the FDA put its one and only drug imetelstat on a full clinical hold after detecting a risk of long-term liver damage following prolonged exposure to the treatment.

Storm-tossed Chimerix rushes into a pilot study, with dying child as its 1st patient

On Tuesday morning, Chimerix CEO Ken Moch was at the center of a media storm, maintaining that there was no way the biotech could responsibly provide its experimental antiviral to a dying child named Josh Hardy, a drug the boy's parents vowed was all that could save the child's life. By Tuesday night, though, Moch had found a way to give the treatment to the 7-year-old after all, as part of the clinical development program for the drug.

La Jolla soars as kidney drug impresses in Phase II, but dosing questions linger

La Jolla Pharmaceutical's chronic kidney disease drug hit its primary endpoint of improving organ function in a Phase II trial, the company said, and while the results sent the biotech's shares skyward by 75%, a quirk in dosing gave some analysts pause.

Northwest Bio jumps as Phase III trial keeps on rolling

In contrast to NewLink Genetics, Northwest Biotherapeutics' interim analysis was a boon to the company's investors, as word that its Phase III trial of a personalized cancer vaccine was going according to plan sent its shares up as much as 10%.

NewLink's cancer vaccine brings hopeful investors back down to earth

After an interim analysis, NewLink Genetics is planning to keep on keeping on with a Phase III study of its cancer vaccine. But that news came as an apparent disappointment to investors, who hoped the drug's promise would result in an early trial termination, and the biotech's shares fell more than 12% on Friday morning.

A Phase III win puts Incyte's cancer drug in line for blockbuster status

Incyte CEO Hervé Hoppenot has been telling anyone who'll listen that his biotech is undervalued and underestimated, and now, with promising late-stage results for its lead drug in a rare blood cancer, the company has a shot at blockbuster sales alongside partner Novartis.

Roche scores upbeat data for a personalized asthma drug with blockbuster hopes

Roche's lebrikizumab significantly reduced the rate of asthma attacks in patients with a severe form of the disease, according to mid-stage trial results, lighting the way for a Phase III study on the novel, personalized treatment.

Roche racks up another PhIII setback as MetMab flops against lung cancer

More than two years ago Roche CEO Severin Schwan picked the cancer drug MetMAb out of the pipeline as one of the company's top blockbuster prospects. But on Monday its oncology R&D arm at Genentech was forced to halt a Phase III combo study matching MetMAb with Tarceva in a failed effort to block metastasis in non-small cell lung cancer after an independent monitoring group flagged the attempt for futility.

REVO looks to expand use of Atryn with preeclampsia PhIII

Framingham, MA-based rEVO Biologics--formerly GTC Biotherapeutics--is planning to put its drug ATryn through a late-stage study for preeclampsia, looking to see if it can help women extend their pregnancy, helping the women as well as their newborns.