One of a handful of obesity devices aiming for the U.S. market has been sidelined. Australian company GI Dynamics has opted, after discussions with the FDA, to terminate its pivotal trial for its EndoBarrier due to safety concerns. The trial had already been placed on hold by the agency in March due to the incidence of hepatic abscess.
Researchers at the University of Southampton have developed a small molecule which they refer to as "Compound 14" that deceives cells into thinking they have run out of energy--spurring on glucose uptake and increasing metabolism.
An analysis by AdverseEvents shows the new generation of obesity meds are holding their own, safety-wise. Still, postmarketing data flag some serious cardiovascular and neuropsychiatric side effects that are worth monitoring, the healthcare informatics firm says.
Wall Street remains skeptical of the first obesity device to be approved by the FDA in more than a decade. The agency approved VBLOC Vagal Blocking Therapy via the EnteroMedics Maestro System in January based on less-than-stellar pivotal data and a mixed panel review. Some investors are backing the company in its follow-on, which has raised $35 million, but at very steep terms.
Rising cardiovascular disease rates in China are directly linked to a change in diet as incomes drive up demand for processed meat with high salt content. That and other dietary changes are creating a heavier population and driving government healthcare cost reforms, Xinhua reports.
The most common weight-loss surgery is the sleeve gastrectomy, in which two-thirds of the stomach is removed to create a pouch that is roughly the size and shape of a banana without touching the intestines. Medtronic has come out with a surgical tool, the GastriSail gastric positioning system, that it says will enable surgeons to consistently size the pouch, as well as to decompress the pouch and test for leaks.
Eli Lilly and Zealand Pharma have scrapped their diabetes and obesity-focused R&D collaboration. The companies teamed up in 2013 to explore using novel peptides to treat Type 2 diabetes and obesity, but 21 months later have decided there is no point pursuing the program.
A tussle over the termination of a trial to assess the cardiovascular safety of obesity drug Contrave is in swing, with Orexigen Therapeutics and Takeda Pharmaceutical entering a dispute process, according to Reuters, with earlier data breaches the subject of a separate issue.
An international group of investigators led by a scientist at Cedars-Sinai has identified a genetic mutation that protects people from Type 2 diabetes. And they say it makes for a good target for drug developers.
No drugmaker wants a generic challenger for a product it relies on--and certainly not two generics challengers. But in the case of Vivus, which has sued Actavis and now Teva over patent infringement for weight-loss drug Qsymia, the generic interest could be an "incremental positive," one analyst believes.