Last year's FDA delay on Novo Nordisk's Tresiba was a major setback for the long-acting insulin that analysts said would severely dampen its earnings potential. But in the ever-changing pharma landscape, a new development has Novo CEO Lars Rebien Sørensen thinking the company may still get Tresiba to the U.S. market ahead of any significant competition.
Last year's stinging FDA rejection for Novo Nordisk's Tresiba wiped billions off the drugmaker's market cap, but, despite getting bogged down with new safety studies, the company believes it can still get its long-acting insulin on the market before its rivals can settle in.
In the race to win FDA approval for a long-acting hemophilia A treatment, Novo Nordisk said its factor VIII therapy came through in a Phase III study, helping the Danish drugmaker play catchup in a three-way contest with Biogen Idec and Bayer.
The growth of Novo Nordisk's information technology group from an internal team to a standalone business makes it a prime target to join the pharma spinoff trend. And having spent the first few months of 2014 considering its options, Novo Nordisk is edging forward with its plans.
As drugmakers are turning more often to technology to make their plants and R&D more productive, they are looking for help with information technology services. Novo Nordisk sees an opportunity in that. The Denmark-based insulin specialist thinks its IT services operation, NNIT, is pretty special, and is looking at spinning it off into a separate business.
Novo Nordisk has stepped closer to a spinoff. The Danish drugmaker wants to hive off its information technology business, NNIT, and it has chosen Morgan Stanley and Danske Bank to advise it on the potential deal.
Novo Nordisk is betting big on new diabetes treatments with plans to spend billions of dollars on R&D. That kind of effort necessitates more production capacity for early phase work, and so the drugmaker will spend $100 million on a new facility to facilitate the push.
Caisson Biotech, which signed on with Novo Nordisk in 2012 for the development of drugs using Caisson's delivery platform HEPtune, expanded the scope of the deal to cover specific indications, including its approach to insulin delivery.
Eli Lilly is one step closer to launching its promising new diabetes drug dulaglutide--and one step closer to putting a crimp in Novo Nordisk's big-selling rival, Victoza.
Eli Lilly is one step closer to launching its promising new diabetes drug dulaglutide--and one step closer to putting a crimp in Novo Nordisk's big-selling rival, Victoza. Lilly unveiled top-line results from a head-to-head trial between its once-weekly Type 2 diabetes remedy and the once-daily Victoza (liraglutide). And dulaglutide stood its own.