Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Spark soars on success of gene therapy study, shot at groundbreaking approval

After repeatedly batting back doubts about its lead gene therapy, Spark Therapeutics says its pivotal study for SPK-RPE65, an FDA-designated "breakthrough" for sight-blighting inherited retinal dystrophies, came through with positive data. The biotech says that the treatment hit the primary and two of three secondary endpoints in the late-stage study, setting up a biologics license application at the FDA next year.

Roche wins kudos for game-changing atezolizumab cancer data

Roche released two more batches of promising outcomes for cancer patients taking its keenly followed PD-L1 checkpoint inhibitor atezolizumab, setting the stage for an accelerated approval campaign on both sides of the Atlantic as one expert in the field touts the pharma giant's chances of realigning the way lung cancer is treated.

Roche scores an MS first with a potential blockbuster on its hands

An in-development drug from Roche performed well against a hard-to-treat form of multiple sclerosis in what the company says is a Phase III first that could shake up a $20 billion market.

UPDATED: Westphal's Verastem concedes lead drug flopped in PhII mesothelioma study

A little more than a month ago Verastem had to mount a hasty defense of its lead drug defactinib (VS-6063) after an abstract hit the Twittersphere outlining poor efficacy and serious adverse events in its study for non-small cell lung cancer. This morning, though, the biotech could do little except acknowledge that the same drug had failed its most advanced study for mesothelioma.

OncoGenex's drug misses the mark in pancreatic cancer

OncoGenex, a small biotech going it alone in cancer R&D, said one of its drug prospects failed in a pancreatic cancer trial, denting the value of the company's pipeline.

Advaxis gets a whiplash after its upbeat assessment of PhII cancer vaccine data

After rounding up a long lineup of collaborations for its cancer vaccine axalimogene filolisbac (ADXS-HPV), Advaxis says that a small study for cervical cancer produced promising outcomes for a significant number of the 26 patients involved.

A player in J&J's hep C cocktail helps hustle a quick cure

Gilead has already made a megablockbuster fortune out of its hepatitis C cure. But the race to cure patients faster (and probably cheaper) is still on. And Achillion today posted some new data from small studies that show its NS5A inhibitor odalasvir (or ACH-3102) could feature prominently in one of the new cocktail therapies now in development at Johnson & Johnson.

UPDATED: Aerie skyrockets on a mixed success in second PhIII glaucoma study

After persuading the FDA to lower the bar on its second Phase III study for its glaucoma drug Rhopressa, Aerie Pharmaceuticals has delivered the efficacy data it asserts regulators will sanction in an upcoming new drug application.

Novo Nordisk buffs Tresiba's blockbuster rep as Sanofi showdown looms

Back in early 2013, the FDA stunned Novo Nordisk and the analysts covering the big diabetes drug player when regulators overrode their outside advisers and decided to require a cardio safety study of its long-acting insulin Tresiba. And now, as Novo steers its way toward a near-term reappraisal at the FDA, the company is ushering in some new data to support the combination of Tresiba and Victoza as analysts once again say an approval is all but certain.

XenoPort plunges as investors sour fast on 'positive' psoriasis data

Shares of Santa Clara, CA-based XenoPort were crushed today after the biotech touted what it called positive preliminary efficacy results from a midstage study of its oral psoriasis drug.
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