Novo Nordisk has its Tresiba approval in the bag, and big ambitions for using it to capture a bigger share of the basal insulin market. But the Danish drugmaker sees another med--the combo drug Xultophy--as an equally potent tool for the same job.
Cleared for liftoff on Friday alongside a combo drug, Ryzodeg, Novo Nordisk's Tresiba can now go up against Sanofi's Toujeo, armed with a raft of data on its heart safety. But one area where Novo doesn't plan to compete with Toujeo--at least not publicly--is on price.
Two years after the FDA's shock rejection of Novo Nordisk's next-generation insulin, the Danish drugmaker has convinced U.S. regulators to change their tune, setting the stage for a market duel with Sanofi.
Novo Nordisk's in-development weekly diabetes treatment met its goals in a second Phase III trial, beating AstraZeneca's Bydureon in a 56-week study.
Novo Nordisk will step up its operations in Iran, saying today it will build a €70 million ($78.1 million) plant to produce its FlexPen prefilled devices to better supply the country with its insulin products.
Western sanctions have not prevented drugmakers from operating in Iran, and some European companies have sales operations there. Now Denmark-based Novo Nordisk has gone a step further, striking an agreement with Iran's government to build a plant to manufacture its insulin-injection devices in the country.
Novo Nordisk has made diabetes its business for about a century, although the company's foray into obesity drugs shows that diseases related to diabetes are close enough. Now Novo has decided to test liraglutide--aka Victoza and Saxenda--or a longer-acting version dubbed semaglutide in fatty liver disease, Bloomberg reports.
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.
Novo Nordisk is out trumpeting new data on its next-gen basal insulin Tresiba and a combo med, Xultophy. New studies to brag about are always good things. But they're particularly well-timed now, with the FDA on the verge of a decision on Tresiba--and analysts fairly certain that the drug will get the agency's stamp of approval.
Novo Nordisk and MIT's Langer Lab announced a three-year collaboration focused on developing next-generation drug delivery devices for the administration of peptides using noninjectable methods. There is an option to extend the deal for an additional three years.