Perhaps the hardest hit by the unintended consequences of well-intentioned legislation, U.S. insulin products continue to be the congressional poster child of all that's wrong with drug prices in America.
HONG KONG – Belgian drugmaker Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson, has decided to return the rights of diabetic obesity treatment HM-12525A to Hanmi Pharmaceutical Co. Ltd. The South Korean company said the decision followed phase II testing by Janssen, which showed the drug achieved the weight loss endpoint but didn't reach Janssen's internal criteria for blood glucose control in obese patients with diabetes.
The artificial pancreas represents a dramatic improvement over existing approaches to management of diabetes, but Sernova Corp. of London, Ontario, is intent on going one better on conventional device technology. The company recently presented the results from an early phase study of its Cell Pouch device with pancreatic islet cells to a major medical conference, and the results suggest that the Cell Pouch with islets will pass the safety bar and may prove efficacious for several measures, including glycemic control.
Boston startup Beta Bionics Inc. is headed into a pair of ambitious pivotal trials in 2020: one starting for an autonomous bionic pancreas device with insulin only and another to follow for a bihormonal version that also includes glucagon. These are expected to offer more precise, easy-to-use blood glucose maintenance for type 1 diabetes patients.
SAN FRANCISCO – Type 2 diabetes often becomes progressively more difficult to manage, moving from prediabetes that can be addressed via weight loss and exercise eventually through requiring multiple daily insulin injections. A novel procedure could offer the opportunity to turn back the clock for type 2 (T2) diabetes patients who are insulin-dependent. Fractyl Laboratories Inc. has developed an outpatient procedure known as duodenal mucosal resurfacing (DMR) that, when used in combination with a GLP-1 receptor agonist drug, can reverse the need for insulin for type 2 diabetes patients who were previously insulin-dependent. That's according to data from a small study presented here on June 9 at the American Diabetes Association's 79th Scientific Sessions.
At a family wedding earlier this month, an uncle was salivating over the prospect that the Vivus Inc. drug Qnexa could soon become the first in a new generation of obesity drugs to gain FDA approval. He needed to lose 50 pounds, he confided, and the drug seemed the answer to his prayers. Since we’ve written extensively about obesity and these drugs in BioWorld Today, he wanted my opinion. I politely inquired whether he had considered dieting and exercise, which could produce similar results without the potential side effects of a prescribed drug – especially one in a category that’s...