Eli Lilly's would-be rival to Pfizer's Ibrance (palbociclib) just gained an inside track at the FDA. Regulators handed Lilly the coveted "breakthrough therapy" designation for abemaciclib, another CDK 4/6 inhibitor with big plans for carving out a niche among patients with advanced breast cancer.
Neurocrine Biosciences says its experimental drug for tardive dyskinesia hit the primary endpoint in a Phase III study, setting up a near-term application with the FDA and spurring a 28% spike in the biotech's share price in premarket trading.
Euroscreen has topped up its bank balance to support the globalization of its clinical trial program. The €16 million ($18 million) round will allow the G-protein coupled receptor specialist to file an IND and advance ongoing Phase II trials of its lead candidate in women's health diseases.
Two weeks after reporting that its cancer vaccine spurred a positive response among a group of cervical cancer patients in a small clinical trial, Advaxis waited until after the market closed today to reveal that the FDA has placed the same cancer vaccine--axalimogene filolisbac (ADXS-HPV)--on a clinical hold, slamming the brakes on four studies.
Genentech has added another piece of the trial puzzle for its MEK inhibitor cobimetinib. The big Roche subsidiary's partner Exelixis announced early Tuesday that the drug combined with Zelboraf hit the mark in a Phase III study, offering a statistically significant overall survival benefit among advanced melanoma patients carrying a BRAF V600 mutation.
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 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.
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.
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, 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.