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.
Orexigen had to wait three long years to take a second shot at an approval for its weight drug NB32, earlier called Contrave. Now it gets to wait another three months for an FDA marketing decision as they talk through a regulatory requirement on tracking cardiovascular outcomes among people taking the therapy.
If Orexigen wins FDA approval for its new weight loss drug, how will it and its pharma partner Takeda take on the obesity market?
If Orexigen wins FDA approval for its weight loss drug NB32 (which used to be called Contrave) by tomorrow's long-awaited PDUFA date--and the odds are in its favor--look for the biotech and its pharma partner Takeda to barrel into a huge obesity market that has provided a chilly reception for a pair of rivals.
Boston startup Gelesis has picked up $12 million in venture funding, cash that'll support its novel approach to obesity treatment: a pill that disperses expanding particles in the gut to make patients feel full.
Months removed from a field-affirming deal with Johnson & Johnson, Second Genome has struck up another Big Pharma partnership, teaming up with Pfizer to launch a sizable study in hopes of better understanding the link between obesity and the microbiome.
Zafgen has been turning heads with some jaw-dropping results from its mid-stage studies for a promising new obesity drug. And now the biotech hopes to parlay its eye-catching, if risky, technology into an $86 million IPO.
U.K. researchers have made advances developing a blood test that could screen for patients who have a genetic predisposition to obesity. Their work, published in the journal Diabetes, involves a team from the University of Southampton, University of Exeter Medical School and elsewhere.