XTalks

SEPTEMBER 15, 2020

A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. In the trial, the vaccine was injected directly into the lymph nodes of type 1 diabetic individuals. The DIAGNODE-2 Trial.

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Vaccination Vaccine Insulin Trials 103

XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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Trials Drugs FDA Approval Clinical Trials 98

XTalks

SEPTEMBER 2, 2020

NAFLD is part of the metabolic syndrome that is characterized by diabetes, or pre-diabetes (insulin resistance), which includes being overweight or obese, elevated blood lipids such as cholesterol and triglycerides, as well as high blood pressure. VK2809 and the VOYAGE Trial. NASH may result in severe liver scarring and cirrhosis.

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Clinical Trials Clinical Trials Trials Insulin 98

XTalks

MARCH 8, 2021

Eli Lilly (NASDAQ: LLY ) reported late last week that its investigational diabetes injection, tirzepatide, demonstrated superiority to Novo Nordisk’s (NASDAQ: NVO ) ozempic (semaglutide) in a Phase III trial. GLP-1 receptor agonists lower blood glucose levels by increasing the production of insulin. SURPASS-2 Clinical Trial.

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XTalks

NOVEMBER 9, 2022

Lilly is also working towards an obesity treatment form of tirzepatide, with trials currently underway to evaluate its weight loss effects. GLP-1 receptor agonists, or incretin (metabolic hormones) mimetics, are analogs of the GLP-1 peptide hormone that binds to the GLP-1 receptor to regulate blood sugar levels by boosting insulin secretion.

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Insulin Hormones FDA Approval Sales 98

XTalks

APRIL 29, 2021

Multiple studies have confirmed that conducting clinical trials with a diverse range of ethnicities, genders, ages, and lifestyles is essential, since these factors can impact a treatment’s effectiveness among different groups. Despite this, ethnic minorities are underrepresented in clinical trials.

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Clinical Trials Clinical Trials Trials Drugs 95

XTalks

FEBRUARY 21, 2024

Recently, Eli Lilly revealed promising results from a mid-stage trial, indicating that its popular drug, tirzepatide (marketed as Zepbound and Mounjaro for weight loss and diabetes, respectively), may be an effective treatment for the fatty liver disease metabolic dysfunction-associated steatohepatitis (MASH).

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Clinical Trials Clinical Trials Trials Insulin 59

XTalks

JUNE 3, 2021

The study , published yesterday in the Endocrine Society’s Journal of Clinical Endocrinology and Metabolism , revealed that two helpings of fruit led to higher measures of insulin sensitivity than those who ate less than half a serving. Diabetes is a growing health problem globally. Keep it Fresh.

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Insulin Development Research Doctors 59

XTalks

DECEMBER 15, 2022

In September 2021, the US Food and Drug Administration (FDA) issued a partial US clinical hold on the phase III DIAGNODE-3 clinical trial of the drug. After over a year, on November 27 this year Diamyd Medical announced that the US FDA lifted the clinical hold on DIAGNODE-3, giving the company a green light to commence the trial in the US.

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Clinical Trials Clinical Trials Vaccination Vaccine 97

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. IGF-1 is an acceptable surrogate endpoint in trials of growth hormone receptor agonists like Somavert, and is preferred for pediatric patient populations.

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Trials Gene Hormones Clinical Trials 98

XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. In a recent webinar, Dr. Olsson described the benefits of flow cytometric receptor occupancy assays in clinical trials. The Benefits of Receptor Occupancy in Clinical Trials.

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Clinical Trials Clinical Trials Trials Antibody 98

XTalks

FEBRUARY 6, 2024

Revita, an outpatient endoscopic procedural therapy, which aims to eliminate insulin needs and enhance glycemic control by ablating dysfunctional duodenal mucosa. Another noteworthy candidate, ALTO-100, also demonstrates efficacy and favorable safety in patients with post-traumatic stress disorder (PTSD) in its Phase II trial.

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Gene Therapy Gene Clinical Trials Clinical Trials 98

Pharmaceutical Technology

JANUARY 31, 2023

Inflation Reduction Act Speaking during the keynote panel “FDA & ARPA-H: Life Sciences, Biopharma & Medtech Priorities in a New Year”, Califf discussed the Inflation Reduction Act of August 2022, which aims to lower prescription drug prices. But then, “you should have to prove it.

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Drugs Regulation Gene Therapy Insulin 130

XTalks

JANUARY 25, 2023

Brenzavvy’s approval was based on an impressive amount of data collected from 23 clinical trials involving over 5,000 patients with type 2 diabetes. TheracosBio will thus be going up against some major market competition.

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FDA Approval Drugs Life Science Cosmetics 52

XTalks

FEBRUARY 8, 2021

Last year, Biocon Biologics and Mylan announced they’d be seeking interchangeable status for their long-acting insulin product Semglee , developed to be an alternative to Sanofi’s Lantus (insulin glargine). MYTH: Treatment-experienced patients cannot be prescribed biosimilars.

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Production Insulin Branding Generic Drugs 78

XTalks

NOVEMBER 3, 2022

Mounjaro was approved this summer as a Type 2 diabetes treatment and is the first diabetes drug with dual action, targeting two hormones involved in insulin production and appetite (GIP and GLP-1). In contrast, Novo’s diabetes drugs Ozempic and Rybelsus (both semaglutide) are just GLP-1 agonists.

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Sales FDA Approval Production Insulin 98

XTalks

SEPTEMBER 22, 2020

The study investigators conducted a post-hoc analysis of data from the Phase III CANVAS Clinical Trial Program. Compared to other anti-diabetic drugs, such as sulfonylurea derivatives and insulin, SGLT2 inhibitors are associated with a low risk of hypoglycaemia. Related: New Drug Treatment Shows Efficacy for Lupus Kidney Disease.

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Trials Clinical Trials Clinical Trials Insulin 95

XTalks

AUGUST 2, 2023

This is largely due to failed trials as a prophylaxis resulting in the European Committee for Medical Products (CHMP) recommending against the approval of Lagevrio. It is a dipeptidyl peptidase-4 inhibitor that keeps insulin levels stable and reduces the amount of glucose produced by the body. billion in 2022. billion ($8.72

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XTalks

MAY 13, 2021

Its latest ad campaign, “Wake Up to the Possibilities” set to the backdrop of Simon Ravenhall’s song “You Are My Sunshine,” boasts about the possibilities of lowering blood sugar for type 2 diabetics through a trifecta of increasing insulin, decreasing glycogen breakdown in the liver and slowing digestion. Eli Lilly spent $14.7

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XTalks

SEPTEMBER 20, 2023

Its approval in January 2023 was grounded in an extensive clinical program comprising 23 trials that enrolled over 5,000 adults diagnosed with type 2 diabetes mellitus. The dosing regimen for Brenzavvy involves a single 20 mg tablet taken each morning. A 30-day supply of Brenzavvy through Cost Plus Drugs is $47.85, plus shipping and handling.

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Pharmacy Drugs Manufacturing Generic Drugs 64

XTalks

AUGUST 17, 2020

With several biologics in the pipeline, including one in early stage clinical trials for head and neck cancer, the company is positioned to engineer highly specific biologics against immune targets in the body. The starting dose of CUE-101 in the clinical trial was quite low (60 µg/kg). Cell-Based Immunotherapy vs. Immune Biologics.

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Protein Engineer Immune Response In-Vivo 98

Drug Discovery World

SEPTEMBER 6, 2022

And whilst clinical trials activity decreased by around 15% compared to 2020, last year still saw a number of regenerative medicines reach the bedside. As is always the case with pharmaceuticals, the industry’s capabilities to manufacture and produce these potentially life-saving therapies will be of concern. .

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Gene Therapy Gene Manufacturing Medicine 52

XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor.

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