Topic:

Clinical Trials

Latest Headlines

Latest Headlines

AstraZeneca rushes immuno-oncology star into PhIII lung cancer study

Anxious to fight off Pfizer's $106 billion marriage proposal, AstraZeneca's research team has rushed its high-profile immuno-oncology drug into a late-stage test. And they're setting out by targeting non-small cell lung cancer in the first Phase III in the MEDI4736 program.

Cytomedix shutters R&D site after PhII failure

Shares of the penny stock biotech slid after the news was released.

Merck halts study of the billion-dollar cancer drug vintafolide

Merck and partner Endocyte have stopped a late-stage study of the ovarian cancer-treating vintafolide on the advice of a data safety monitoring board, saying the much-hyped drug failed to move the needle on progression-free survival.

Amid Zohydro controversy, Teva, Purdue and Pfizer race ahead with new pain drugs

Teva announced that its abuse-resistant version of extended-release hydrocodone--the opioid CEP-33237--aced a pivotal Phase III. Unsurprisingly, the pain drug beat out a placebo in the chronic back pain study, which sets the stage for a new drug application for later in the year. Purdue Pharma, meanwhile, has already raced to the FDA with its own tamper-resistant version of hydrocodone.

Merrimack heads to the FDA after scoring positive PhIII for pancreatic cancer

Merrimack Pharmaceuticals got roughed up when it went public back in 2012, then took it on the chin--twice--when one of their cancer drugs partnered with Sanofi failed two mid-stage studies. But this morning its stock price sailed up about 90% on the news that its lead drug scored a win in Phase III in a population of patients with advanced pancreatic cancer.

GlaxoSmithKline ups odds on heart drug hopeful with a changeup in endpoints

Expecting to improve its odds of success for the experimental heart drug darapladib, a top drug prospect that failed its first late-stage test, investigators at GlaxoSmithKline have changed up the primary endpoint in the remaining Phase III study that reads out later this quarter.

Transgene takes a hit as Novartis shreds $800M option deal

France's Transgene took a hit this morning after the biotech announced that Novartis had decided to pass on its option for the therapeutic cancer vaccine TG4010. But the CEO says he's laying the groundwork for a late-stage study, confident that he can find another partner.

CytoKinetics' ALS drug also misses string of secondary endpoints

Late last week, shares of CytoKinetics tanked when it put out the word that its lead drug for Lou Gehrig's disease had missed the primary endpoint. Today, the biotech added that the ALS drug also missed a string of secondary endpoints, as well. There was, though, one bright spot: The drug achieved the secondary endpoint on what's called "slow vital capacity," billed as an important indication of disease prevention.

Amicus shares rally as a revised PhIII delivers positive Fabry data

Last fall, when GlaxoSmithKline decided to bail on Amicus Therapeutics and bowed out of their deal for the late-stage Fabry disease drug migalastat, some investors gave up on the company. After all, the drug had already failed the first step in the first of two Phase III studies, unable to provide a statistically significant improvement over a placebo arm.

OncoGenex, Teva flag a failed PhIII for prostate cancer drug

Shares of OncoGenex went into meltdown mode this morning after the biotech and its partner Teva put out word that their experimental prostate cancer drug had flunked a long-awaited Phase III study. Shares of OncoGenex immediately shed more than half their value in the reckoning with investors.