Diabetes

Eli Lilly And Co (NYSE: LLY) posted data from the SURPASS-3 CGM sub-study of tirzepatide in a subpopulation of 243 participants who wore continuous glucose monitoring (CGM) for 7 to 10 days at baseline. Related Link: Eli Lilly's Tirzepatide Tops Novo's Semaglutide...

Reuters reports that Bausch Health Companies Inc (NYSE: BHC) will pay $300 million to settle an antitrust lawsuit related to illegally maintaining a monopoly on diabetes drug Glumetza. The FDA first approved Glumetza, a once-daily extended-release version of metformin, owned by...

Codexis Inc (NASDAQ: CDXS) has amended and extended its agreement with Merck & Co Inc (NYSE: MRK) to license and supply a proprietary enzyme used to manufacture sitagliptin. Sitagliptin is an active pharmaceutical ingredient (API) in Merck's two anti-diabetic...

A smart monitor company that received FDA approval in 2015 has seen a five-year stock performance that has outperformed the returns of Apple Inc (NASDAQ: AAPL), Alphabet Inc (NASDAQ: GOOG)(NASDAQ: GOOGL) and Amazon.com, Inc. (NASDAQ: AMZN). The company’s five-year outlook and guidance show...

The FDA has approved Xeris Pharmaceuticals Inc's (NASDAQ: XERS) Gvoke Kit for severe hypoglycemia in pediatric and adult patients with diabetes ages two years and above.  Gvoke Kit is the first ready-to-use glucagon available in a single-use vial and single-use syringe kit...

The FDA has approved the use of Eli Lilly And Co's (NYSE: LLY) Lyumjev (insulin lispro-aabc injection) 100 units/mL with Insulet Corporation's (NASDAQ: PODD) insulin management systems. Lyumjev, approved by the FDA in June 2020, is a formulation of insulin...

PolarityTE Inc (NASDAQ: PTE) has announced final data from a trial evaluating SkinTE plus standard of care (SOC) vs. SOC alone for Diabetic Foot Ulcers. The trial met the primary endpoint of wound closure at 12 weeks and the secondary endpoint of Percent Area Reduction (PAR),...

The FDA has approved AstraZeneca Plc's (NASDAQ: AZN) Budureon BCise (exenatide extended-release), once-weekly injectable suspension for type 2 diabetes (T2D) in pediatric patients (10 to 17 years) as an adjunct to diet and exercise. The approval was supported by the positive...

Precigen Inc's (NASDAQ: PGEN) subsidiary Precigen ActoBio announced topline results from the Phase 1b/2a study evaluating AG019 ActoBiotics to treat recent-onset type 1 diabetes (T1D). Results were presented at the Federation of Clinical Immunology Societies 2021. Phase 1b AG019...

Novo Nordisk A/S (NYSE: NVO) has resubmitted a label expansion application to FDA for Ozempic (semaglutide) to introduce a new dose of 2.0 mg.  Semaglutide is a glucagon-like peptide-1 (GLP-1) analog. The Type 2 diabetes injection is currently approved at 0.5-mg and 1-mg doses...

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-7 in favor of recommending approval of Provention Bio Inc’s (NASDAQ: PRVB) teplizumab to delay the development of type 1 diabetes in high-risk children and adults, with most committee members...

Eli Lilly and Co (NYSE: LLY) has reported topline data from Phase 3 SURPASS-4 clinical trial evaluating tirzepatide in adults with type 2 diabetes and increased cardiovascular risk. Measuring the GLP-1 receptor agonist tirzepatide against titrated insulin glargine, Lilly reported...

PolarityTE Inc (NASDAQ: PTE) has announced preliminary topline data from a multi-center randomized controlled trial evaluating SkinTE for the treatment of Diabetic Foot Ulcers. The 100-subject trial, which assessed SkinTE plus standard of care (SOC) vs. SOC alone, met...

While reporting financial results for the second fiscal quarter of the year, during which revenues grew more than 15% to $4.9 billion, Becton Dickinson and Co (NYSE: BDX) also laid out its plans to spin off its diabetes-focused segment. Split Highlights: The split...

The FDA has approved AstraZeneca plc's (NASDAQ: AZN) Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 inhibitor, to treat chronic kidney disease (CKD) even in patients without diabetes. Under the new approval, Farxiga can be used to reduce the risk of declining...