USGI Medical expects that its latest infusion of $19.5 million in cash and debt will enable it to complete a U.S. pivotal trial and to submit for FDA approval. The pivotal trial is currently in the follow-up phase; the financing will also enable a crossover study of patients who previously had received sham treatment in the trial.
Novo Nordisk's obesity therapy Saxenda is on a roll. Just over a month after snagging FDA approval, the drug scored a positive recommendation on Thursday from Europe's Committee for Medicinal Products for Human Use (CHMP). But by the time it gets to the regulatory finish line, the med may have some competition on the continent.
Micro cap EnteroMedics is up 35% in early trading on the news that it has garnered an FDA approval for its Maestro vagal blocking therapy as an obesity treatment. The device was narrowly supported by a June FDA panel due to concerns about efficacy. In addition, another obesity device company, Obalon Therapeutics, has secured $30 million to complete a U.S. pivotal trial in 2015 for its nonsurgical weight loss balloon.
Zafgen charted a third major victory for its in-development obesity drug, spurring weight loss for patients who have endured brain injuries and stoking hopes for success in Phase III.
Two months after its self-imposed deadline, the FDA finally signed off on Novo Nordisk's first weight-loss therapy, a milestone for the company as it blueprints a future in obesity.
Private insurers and public payers have refused to cover obesity drugs--or foisted big copays onto patients--dragging down new drugs. So, when Takeda rolled out Orexigen's new obesity drug Contrave a few weeks ago, the Japanese drugmaker also rolled out a direct-delivery program, Direct Save.
In new late-stage data, Novo Nordisk's inaugural obesity drug spurred statistically significant weight loss compared to placebo, bolstering the company's case as it works to build a portfolio of such treatments.
ReShape Medical said about a year ago that it had positive U.S. pivotal obesity data for its ReShape Integrated Dual Balloon. Now it has offered a glimpse of that data for the first time, ahead of an FDA review that's expected to come during the first half of 2015.
Researchers from the National University of Singapore have identified several potent inhibitors that selectively target FTO, a gene that has been associated with fat mass and obesity in certain people.
Researchers have identified a hormone that is associated with fructose, fibroblast growth factor 21 (FGF21), which increases rapidly in the blood after fructose ingestion. High FGF21 levels in the blood are associated with obesity, insulin resistance and nonalcoholic fatty liver disease in both humans and animals.