Despite "very interesting" preclinical data emerging on a heap of immuno-oncology molecules, "you still have to go into patients and show that it works," said Briggs Morrison, CEO of Syndax Pharmaceuticals Inc. "We went after patients with the biggest unmet need who are very hard to treat to try to demonstrate that we're actually seeing something in those patients. Not everybody has done that."

In the second half of the year, Minerva Neurosciences Inc. plans to initiate a single phase III trial of lead candidate MIN-101 that will enroll about 500 individuals with schizophrenia to evaluate improvement in negative symptoms. If the trial succeeds, the FDA agreed the data could form the basis – in conjunction with findings from the company's phase IIb trial – for a new drug application (NDA) submission.

Insights into the role of the microbiome in human disease represented one of the hottest tickets in town at Digestive Disease Week (DDW) 2017 in Chicago. Multiple biopharmas have efforts afoot to marshal the beneficial microorganisms that colonize the human body even though researchers are still endeavoring to show cause and effect between microbiota – the microorganisms that live in an established environment – and disease. One major question still confronting the field, for instance, is whether dysbiosis causes or results from intestinal inflammation, since the evidence doesn't yet point to an irrefutable conclusion.

CHICAGO – After gaining approval in January for Trulance (plecanatide) to treat chronic idiopathic constipation (CIC), Synergy Pharmaceuticals Inc. wasted little time posting the complete phase III dataset on a bigger win sought in irritable bowel syndrome with constipation (IBS-C).

CHICAGO – An 18 millimeter capsule colonoscope, outfitted with an internal magnet and guided by an external magnet attached to a robotic arm, may represent the next generation of colonoscopy technology, according to findings presented at Digestive Disease Week (DDW) 2017 in Chicago. "Colonoscopy saves lives through colon cancer screening, in that it can both identify and remove precancerous lesions and tumors," observed Keith Obstein, associate professor of medicine at Vanderbilt University Medical Center. "Unfortunately, a large segment of the population foregoes age-recommended colon cancer screening." The reasons are well known to clinicians, principally fear...

CHICAGO – An 18 millimeter capsule colonoscope, outfitted with an internal magnet and guided by an external magnet attached to a robotic arm, may represent the next generation of colonoscopy technology, according to findings presented at Digestive Disease Week (DDW) 2017 in Chicago.

CHICAGO – Drug-induced liver injury, or DILI, doesn't affect a large number of patients on drug therapy, but in clinical practice it disproportionately impedes patient care. When elevated liver enzymes are detected, treating physicians must consider whether DILI is implicated and, if so, which drug is involved, often forcing them to discontinue multiple medications while they investigate the cause.

CHICAGO – Conventional weight loss surgery – whether laparoscopic banding or laparoscopic sleeve gastrectomy – represents an important treatment option for individuals struggling to fight obesity. Not every patient seeking weight loss surgery is a candidate for these procedures, however. Now, these individuals may have another option. A study presented Saturday at Digestive Disease Week (DDW) 2017 in Chicago and featured in the meeting's press conference suggested that individuals with obesity who are not candidates for weight loss surgery may benefit from nonsurgical endoscopic sleeve gastroplasty (ESG), a procedure performed at a growing number of...

CHICAGO – Conventional weight loss surgery – whether laparoscopic banding or laparoscopic sleeve gastrectomy – represents an important treatment option for individuals struggling to fight obesity. Not every patient seeking weight loss surgery is a candidate for these procedures, however.