Reports of the death of the market for continuous glucose monitors in individuals with type 2 diabetes are greatly exaggerated, Abbott Laboratories studies show. Far from being unnecessary given the enthusiastic uptake of GLP-1 drugs, the devices significantly improve blood glucose control regardless of the drug used, duration of SLP-1 therapy or use of insulin, presentations at the International Conference on Advanced Technologies & Treatments for Diabetes in Florence, Italy, demonstrated.
In a grand slam for Dexcom Inc., the U.S. FDA cleared its Stelo glucose biosensor system for over-the-counter marketing, making it the first integrated continuous glucose monitor available without a prescription. Designed for use by the 25 million adults with diabetes who do not use insulin and do not have problematic hypoglycemia, the FDA indication expanded the clearance for Stelo to include individuals without diabetes “who want to better understand how diet and exercise may impact blood sugar levels,” dramatically expanding the market opportunity.
Creative Medical Technology Holdings Inc.'s Immcelz (CELZ-101) has been awarded orphan drug designation by the FDA. Immcelz is aimed at preventing allograft rejection in patients undergoing pancreatic islet cell transplantation.
Osang Healthcare Co. Ltd. is attempting a second listing on the Kosdaq market with an IPO, planned sometime in March, to fund the company’s growth beyond the COVID-19 pandemic.
The U.S. Court of Appeals for the Sixth Circuit made it clear that it’s the court’s purview, not a jury’s, to determine whether an expert’s testimony is “relevant and reliable” when it comes to issues such as causation. It gave that lesson Feb. 13 when it affirmed a lower court’s dismissal of multi-district litigation in which the plaintiffs claimed that Onglyza (saxagliptin) and Kombiglyze (saxagliptin/metformin hydrochloride), developed by Astrazeneca plc and Bristol Myers Squibb Co., caused their heart failure.
Insulet Corp. received the greenlight from EU regulators to combine its Omnipod 5 automated insulin delivery (AID) system with Abbott Laboratories Freestyle Libre 2 Plus sensor to treat individuals aged two years and older with type 1 diabetes.
Amgen Inc. reported its latest financial numbers but much of the conversation on the Feb. 6 conference call was about obesity. The same was true with Eli Lilly and Co. as weight loss drove the narrative.
The week closed out with two IPOs on their way in. Alto Neuroscience Inc. (NASDAQ:ANRO) and Fractyl Health Inc. (NASDAQ:GUTS) both debuted on Wall Street with offerings looking to raise combined $238.6 million.
Kakao Healthcare Corp. launched an artificial intelligence (AI)-powered mobile application called PASTA on Feb. 1 for continuous glucose monitoring (CGM)-based diabetes care. PASTA pairs with two types of CGM sensors, either from Seoul-based I-sens Inc.’s Caresens Air or San Diego-based Dexcom Inc.’s G7 system.
Trinity Biotech plc. paid $12.5 million to acquire Waveform Technologies Inc.’s biosensor and continuous glucose monitoring (CGM) assets. It also formed a partnership with Bayer AG to launch a CGM biosensor in China and India. These moves are part of Trinity’s transformation strategy to become a leading player in wearable biosensor technology.
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