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.
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.
The FDA has slammed the brakes on the late-stage Alzheimer's development program for encenicline after investigators reported a "small" number of serious gastrointestinal adverse events among patients taking the drug, the lead therapy for Waltham, MA-based Forum Pharmaceuticals.
Sanofi's second pivotal trial for a new diabetes drug combo came through with positive head-to-head results against Lantus, according to its biotech partner. And that clears the last hurdle standing in the way of marketing applications on both sides of the Atlantic as it tries to shore up an eroding blockbuster franchise against heated competition.
Last fall, Acacia Pharma's virtual crew cheered the late-stage success of a drug designed to prevent postoperative nausea and vomiting by bringing in strategic advisers to help hammer out a path forward. And evidently, they concluded that setting out to raise $230 million on the London Stock Exchange was the right way to go.
AstraZeneca may still be in front in the late-stage race to develop a targeted new drug for non-small cell lung cancer, but new data has analysts wondering if its lead over rival Clovis has shortened in the final stretch.
CRO giant Icon is working with IBM in hopes of making clinical trials more efficient, tapping the company's famed Watson technology with an eye on speeding up recruitment and site selection.
After 12 months of fraud accusations, legal threats and stock price swings, Clal Biotechnology and Hyperion Therapeutics now have data from the heavily scrutinized Phase III trial of the diabetes drug at the center of their spat. The trial was a flop, Globes reports.
Days after the FDA reiterated its demand for a new trial of AcelRx's pain drug Zalviso before it can reconsider a marketing application, the small biotech says it has garnered positive data from its late-stage study of another pain remedy in the pipeline.
GlaxoSmithKline, which recruited more than 16,000 patients in a monumental postapproval effort to distinguish Breo Ellipta by improving the mortality rates of high-risk patients with COPD, says that study failed.