One of the first deals Flemming Ornskov struck as the new CEO of Shire has soured quickly. The company says that its therapy for dry eye, lifitegrast, missed one of two key endpoints in a Phase III study, raising some serious questions about its future.
A lack of exposure to infections early in life is one of many proposed contributing factors to development of multiple sclerosis. With this in mind, some have questioned whether giving the immune system a light workout could stave off the autoimmune disorder.
Sanofi has peeled back the cover on another chapter of Phase III data for U300, advancing its case that its next-gen diabetes therapy can be safer and just as effective as its blockbuster Lantus as it sets the stage for a regulatory pitch next year. But analysts may be left wondering if the long-acting insulin can successfully beat back rivals with a better set of data.
Fresh off a $25 million IPO, Evoke is riding into Phase III with its gastroparesis-treating nasal spray, and now the biotech has recruited SynteractHCR to serve as its go-to CRO for the late-stage effort.
Shares of Cubist Pharmaceuticals surged this morning after the Lexington, MA-based company announced that it had reaped promising data from its Phase III of its antibiotic candidate ceftolozane/tazobactam in complicated urinary tract infections.
More than two years after Orexigen began a forced march back through a $100 million Phase III study for its weight drug Contrave, the biotech is back with the news that it scored the positive interim results it needs for a return trip to the FDA. And the drug developer says it can look ahead to a potential approval as early as June, 2014.
The Vietnamese government is looking to boost its share of the world's clinical research market, signing a deal with CRO giant Quintiles to get the ball rolling.
Canada's Oncolytics Biotech trumpeted some promising late-stage results for its viral head and neck cancer therapy, but a distortion in the company's overall survival data rattled investors, sending its shares down as much as 8.6% on Thursday.
The trial found two doses of the adjuvanted cell culture vaccine immunologically protected 85% of participants.
Daiichi Sankyo's atrial fibrillation-treating edoxaban posted promising results in Phase III, matching the stroke-prevention prowess of warfarin with a better safety profile, but the drug may struggle to carve out market share in a cluttered space.