Valeritas (NSDQ:VLRX) announced that the company and its subsidiaries filed voluntary petitions for Chapter 11 bankruptcy, having agreed to sell substantially all of the business to Zealand Pharma (CPH:ZEAL). The agreement is slated to provide a total cash consideration of $23 million along with certain liabilities related to the ongoing business. Once the acquisition is completed, Zealand plans […]
Zealand Pharma
Beta Bionics’ bionic pancreas wins breakthrough status from FDA
The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The designation provides Beta Bionics with priority FDA review. It covers all configurations of the device — insulin-only, glucagon-only, and bi-hormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution, according to Boston-based Beta Bionics. […]
Beta Bionics starts new trial for bionic pancreas
Boston-based Beta Bionics said this week that the first patients have begun home use of dasiglucagon in a clinical trial of the company’s iLet bionic pancreas system for people with Type 1 diabetes. The iLet device features an autonomous, dual-chamber infusion pump that is powered by dosing algorithms. Using machine learning and data from a continuous […]
FDA request delays timeline for Sanofi’s iGlarLixi drug-device combo for diabetes
By Sarah Faulkner The FDA’s request for more data on the iGlarLixi drug-device combination for treating Type II diabetes pushed the timeline for a decision back 3 months, Sanofi (NYSE:SNY) and Zealand Pharma (CPH:ZEAL) said last week. Sanofi said August 19 that it submitted a new data package for iGlarLixi, an injection pen designed to […]
