Novo Nordisk has made it official: The Danish drugmaker is making a full-fledged go at obesity R&D, looking to build a Seattle hub and hire some investigators as it expands its research palate.
Novo Nordisk has made it official: The Danish drugmaker is making a full-fledged go at obesity R&D, looking to build a Seattle hub and hire up some investigators as it expands its research palate.
Analysts have been waiting--and waiting--for drugmakers to realize the growth they've predicted for the obesity market. And with a couple of pharma companies preparing to pony up R&D and marketing resources for their obesity products, it could finally be on the way.
In the midst of its first major foray into treating obesity, Novo Nordisk is liking what it sees in the space, and now the Danish giant plans to hire hundreds of researchers in a gambit to develop new treatments for the global scourge.
More than three long years after Orexigen was turned back at the FDA and forced to do a costly late-stage safety study of its weight drug Contrave, the agency has come back and given its seal of marketing approval to the drug.
ReShape Medical revealed the first postapproval data from the EU for its nonsurgical, balloon-based weight-loss system: 42% of excess weight loss on average with a variance of 23%. But the company cautions that because of the different way the trials are designed, it won't have similar results when it releases pivotal U.S. trial data in November.
Investigators at The Scripps Research Institute discovered a signaling pathway that switches on a calorie-burning phenomenon in cells.
USGI Medical, a California-based devicemaker focused on incisionless, endoscopic procedures for weight loss, reflux and advanced therapeutic endoscopy, said enrollment has been completed for a pivotal study to evaluate the company's POSE (Primary Obesity Surgery, Endolumenal) procedure.
There has been no new medical device to treat obesity approved by the FDA in more than a decade. A series of companies are hoping to be the first, including ReShape Medical, which has filed a PMA with FDA for its ReShape Integrated Dual Balloon System aimed at weight loss for the obese with a body mass index from 30 to 40.
An implantable device to treat morbid obesity with vagal nerve blocking therapy will be considered by the FDA's Gastroenterology-Urology Devices panel on June 17. Its chances going into the meeting don't look great: The panel documents point out that it didn't meet either of its primary efficacy endpoints and the panel date was already delayed once in March. Still, while the 12-month data aren't good, at 18 months the device looks a bit more promising.