Endocrinology

Medtronic to Acquire Smart Insulin Pen Company Companion Medical

DUBLIN and SAN DIEGO, Aug. 11, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the planned acquisition of privately-held Companion Medical, manufacturer of InPen — the only U.S. FDA-cleared smart insulin pen system paired with an integrated diabetes management app on the market. The …

Read More »

Lexicon Pharmaceuticals Announces Topline Phase 3 Data From Four Phase 3 Sotagliflozin Studies in Type 2 Diabetes

THE WOODLANDS, Texas, July 21, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced topline data from four Phase 3 sotagliflozin studies in type 2 diabetes: SOTA-MONO, SOTA-SU, SOTA-GLIM and SOTA-INS. The final results of these studies will be preserved for upcoming medical congresses and publications. “We are pleased with …

Read More »

FDA Approves Lyumjev, Lilly’s New Rapid-Acting Insulin

INDIANAPOLIS, June 15, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company’s (NYSE: LLY) new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. Lyumjev is a novel formulation of insulin lispro, developed to speed …

Read More »

FDA Approves Trulicity for Reduction of Major CV Events in Adults with Type 2 Diabetes with CV Disease or Multiple Cardiovascular Risk Factors

INDIANAPOLIS, Feb. 21, 2020/PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Trulicity® (dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular (CV) disease or multiple cardiovascular risk factors. This decision makes Eli Lilly and Company’s (NYSE: LLY) Trulicity the first and only type …

Read More »

New Research Shows EarlySign’s AI Solution Can Identify Prediabetic Patients at High Risk of Developing Diabetes

TEL AVIV, Israel, Jan. 22, 2020 /PRNewswire/ — Medial EarlySign (earlysign.com), a leader in machine learning-based solutions to aid in the early detection and prevention of high-burden diseases, today announced the results of a new study assessing the effectiveness of its Pre2D-Flag AlgoMarker™ algorithmic model to identify individuals at high …

Read More »

FDA Approves Ozempic to Reduce Cardiovascular Risk in Adults with Type 2 Diabetes and Known Heart Disease

PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic® (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 …

Read More »

FDA Rejects Lexicon’s NDA for Sotagliflozin for Treatment of Patients with Type 1 Diabetes

The Woodlands, Texas, December 2, 2019 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the Office of New Drugs of the U.S. Food and Drug Administration (FDA) has reiterated the FDA’s prior position and denied Lexicon’s appeal of the Complete Response Letter in relation to the New Drug Application for …

Read More »

FDA Advisory Committee Votes Against Approval of Empagliflozin as an Adjunct to Insulin for Patients with Type 1 Diabetes

RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 13, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14 to 2 that the benefits of empagliflozin 2.5 mg do not outweigh the risks to support approval as an adjunct to insulin for adults with …

Read More »

FDA Approves Fiasp for Use in Insulin Infusion Pumps for Adults with Type 1 or Type 2 Diabetes

PLAINSBORO, N.J., Oct. 22, 2019 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes.1 Fiasp®, a …

Read More »

FDA Approves AstraZeneca’s Farxiga to Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved FARXIGA (dapagliflozin) to reduce the risk of hospitalization for heart failure (hHF) in adults with type 2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. The approval is based on …

Read More »