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Month: June 2020

Investigational, once-weekly insulin icodec showed comparable efficacy and safety to once-daily insulin glargine U100 in phase 2 trial

Bagsværd, Denmark, 15 June 2020 ­– Today, Novo Nordisk announced results from a phase 2 clinical trial of investigational insulin icodec, a once-weekly basal insulin analogue. In the trial, adults with type 2 diabetes randomised to once-weekly insulin icodec achieved similar blood sugar control and a similar safety profile compared with adults with type 2 diabetes randomised to once-daily insulin glargine U100. Results were presented during the 80th Scientific Sessions of the American Diabetes Association.1This 26-week, randomised, double-blind, double-dummy, treat-to-target phase 2 clinical trial involved 247 insulin-naïve adults with type 2 diabetes inadequately controlled with metformin with or without a DPP-4i. The primary endpoint showed that the change from baseline to week 26 in blood sugar control (HbA1c) was similar in participants...

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Pilgrim’s CEO on Paid Leave of Absence

GREELEY, Colo., June 14, 2020 (GLOBE NEWSWIRE) — Pilgrim’s Pride Corporation (NASDAQ: PPC) today announced that president and CEO Jayson Penn has begun a paid leave of absence, effective immediately. During his leave of absence, Mr. Penn intends to focus on his defense of the recently disclosed indictment against him, to which he has pleaded not guilty. The Pilgrim’s Board of Directors has appointed Fabio Sandri, Pilgrim’s CFO, as interim president and CEO.“Pilgrim’s operates with the highest standards of integrity and is committed to free and open competition that benefits both customers and consumers,” said Gilberto Tomazoni, chairman of Pilgrim’s Board of Directors. “The board takes the recent allegations very seriously and believes it is in the best interests of both Jayson and the company that he is given the opportunity to...

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Stockwik presenterar informationsmemorandum för fullt garanterad företrädesemission om ca 12,5 MSEK

Informationen i detta pressmeddelande är inte avsedd att publiceras, offentliggöras, eller distribueras, direkt eller indirekt, i eller till, Australien, Hongkong, Kanada, Nya Zeeland, Japan, Schweiz, Singapore, Sydafrika, USA, eller någon annan jurisdiktion där sådan publicering eller distribution skulle bryta mot tillämpliga lagar eller regler. Se avsnittet ”Viktig information” i slutet av detta pressmeddelande.Stockwik Förvaltning AB (publ) publicerar informationsmemorandum för fullt garanterad företrädesemission om 12,48 MSEK samt övertilldelningsemission om 1,87 MSEK i enlighet med beslut vid extra bolagsstämma den 3 juni 2020 i syfte att finansiera förvärv av Admit Ekonomi AB. Informationsmemorandumet finns publicerat i sin helhet på Stockwiks hemsida; www.stockwik.se, på Consensus Asset Managements hemsida; www.consensusam.se/stockwik,...

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Zealand Pharma presents clinical and non-clinical evidence for dasiglucagon rescue therapy at the 80th Scientific Sessions of the American Diabetes Association

Press release – No. 09 / 2020  Zealand Pharma presents clinical and non-clinical evidence for dasiglucagon rescue therapy at the 80th Scientific Sessions of the American Diabetes Association              The dasiglucagon HypoPal® rescue pen is under FDA review as a potential fast and effective treatment of severe hypoglycemia in diabetes In Phase 3 trials in pediatric and adult patients with diabetes, dasiglucagon has consistently demonstrated a median time to recovery from hypoglycemia of 10 minutesCopenhagen, June 14, 2020 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company changing lives with innovative peptide-based medicines, presented elaborated results from two Phase 3 clinical studies with dasiglucagon as treatment for severe hypoglycemia as well as one preclinical PK/PD study investigating aqueous...

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Esperion Announces Pooled Analysis from Phase 3 LDL-C Lowering Clinical Development Program of NEXLETOL™ (Bempedoic Acid) Tablets Presented at the American Diabetes Association 80th Scientific Sessions

ANN ARBOR, Mich., June 14, 2020 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today announced that pooled analysis from four Phase 3 clinical studies of NEXLETOL were presented at the American Diabetes Association 80th Scientific Sessions.  According to the American Diabetes Association (ADA) guidelines, elevated LDL cholesterol is a common problem for people with diabetes. Also referred to as hyperlipidemia, this condition greatly increases the risk of developing cardiovascular disease.The presentation, titled “Efficacy and Safety of Bempedoic acid in Patients with Diabetes, Prediabetes, and Normoglycemia: Analysis of Pooled Patient-Level Data From 4 Phase 3 Clinical Trials” was delivered by Lawrence A. Leiter, MD, FRCPC, FACP, FACE, FAHA Director of the Lipid Clinic at St. Michael’s Hospital and Professor of Medicine and Nutritional...

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Investigator-Initiated Study Shows Switching to Afrezza® Improves Glucose Control with No Additional Hypoglycemia in T2DM

WESTLAKE VILLAGE, Calif., June 13, 2020 (GLOBE NEWSWIRE) — MannKind Corporation (Nasdaq: MNKD) announced that data from a new clinical study of Afrezza® (insulin human) Inhalation Powder will be presented at the American Diabetes Association’s 80th Scientific Sessions during the ePoster session (Poster 990) on Saturday, June 13, 2020.The lead author, Mark Kipnes, MD (Diabetes and Glandular Disease Clinic, San Antonio, Texas) presented clinical data from an investigator-initiated observational “switch” study that evaluated quality of life and glucose control in patients with type 2 diabetes previously treated with injected mealtime insulin. Following conversion to Afrezza, patients were followed for 14 weeks, and glucose control (measured by both A1C and glucose time in range), rates of hypoglycemia and quality of life were assessed.Study...

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Lexicon Pharmaceuticals Presents Clinical Data at 80th American Diabetes Association Scientific Sessions

THE WOODLANDS, Texas, June 13, 2020 (GLOBE NEWSWIRE) —  Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today presented six posters for ZynquistaTM (sotagliflozin) at the virtual 80th American Diabetes Association (ADA) Scientific Sessions including additional efficacy and safety data patients with type 2 diabetes and moderate and severe renal impairment.Phase 3 CKD-3 StudyIn the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-3 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and moderate (CKD Stage 3) renal impairment.The study met its primary endpoint, demonstrating that sotagliflozin 400 mg significantly reduced A1C in the entire population of patients with moderate renal impairment compared...

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Switching to Ozempic® from another GLP-1 RA significantly reduced blood sugar and weight in people with type 2 diabetes in routine clinical practice

· A separate real-world study showed that people with type 2 diabetes on two oral antidiabetic drugs who intensified with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) were significantly more likely to reach their blood sugar goals and lose weight compared to adding a further oral antidiabetic drug(s) or insulin.1Bagsværd, Denmark, 13 June 2020 ­– Novo Nordisk today announced results from two real-world studies: EXPERT, which confirms the efficacy Ozempic® (once‑weekly semaglutide) demonstrated in the SUSTAIN clinical trial programme, and PATHWAY, which supports recommendations in clinical guidelines by showing that initiation of a GLP-1 receptor agonist (GLP-1 RA) helps people with type 2 diabetes reach their blood sugar goals (measured by HbA1c) while also losing weight. These studies, which analysed data from US databases,...

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Medtronic Shares Study Results on First of Its Kind Extended Wear Infusion Set from American Diabetes Association Conference

DUBLIN, June 13, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced data on its extended wear infusion set presented at the virtual 80th Scientific Sessions of the American Diabetes Association (ADA). Infusion sets allow people on insulin pump therapy to deliver insulin under the skin to maintain healthy blood glucose levels. Current generation infusion sets must be changed every two to three days. The research revealed that Medtronic Extended infusion sets last twice as long as standard infusion sets with study results suggesting they could provide safe and comfortable wear for patients using Medtronic insulin pumps. It is the only infusion set in the industry with the ability to be used for up to 7 days and adds to the portfolio of technology offerings from Medtronic which...

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vTv Therapeutics Presents Two Late-Breaking Poster Sessions on Simplici-T1 Study at the American Diabetes Association’s Virtual Sessions Supporting the Potential of TTP399 as First-in-Class Oral Adjunctive Therapy for Type 1 Diabetes Patients

– Treatment with TTP399 resulted in significant improvements in HbA1c with reduction in insulin, without increasing risk of hypoglycemia or diabetic ketoacidosis (DKA) –HIGH POINT, N.C., June 13, 2020 (GLOBE NEWSWIRE) — vTv Therapeutics Inc. (Nasdaq: VTVT) today made two presentations at the American Diabetes Association’s 80th Scientific Sessions. The clinical data presented from the positive Phase 2 Simplici-T1 Study confirms the potential for TTP399 to provide a benefit beyond standalone insulin treatment for patients living with type 1 diabetes.“These results from the Simplici-T1 Trial are a major step towards the future of care in type 1 diabetes.  They demonstrate that TTP399, a once-a-day pill, reduces HbA1c and improves time in range, without increasing hypoglycemia or any signal for adverse events including...

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